1. THE DIMATCH-HTA STUDY
DETERMINANTS AND IMPACT OF
MEDICATION ADHERENCE AND
THERAPEUTIC CHANGE IN THE
CONTROL OF ARTERIAL HYPERTENSION
AMONG COHORTS OF IMMIGRANTS AND
NON-IMMIGRANTS AT THE PRIMARY CARE LEVEL
Principal Investigator: Evangelista Casimiro Rocha
Research team: Paulo Nicola, Mário Carreira, Violeta Alarcão, Paulo Nogueira,
Milene Fernandes, Maria Alves Cortes, Marta Godinho
Scientific consultants: Charles Agyemang, José Pereira Miguel
Unidade de Epidemiologia
Instituto de Medicina Preventiva
Faculdade de Medicina de Lisboa
June 2008

2. INDEX
SUMMARY …………………………………………………………………….. 3
RESUMO ………………………………………………………………………. 4
BACKGROUND ……………………............................................................. 5
SPECIFIC AIMS ……….............................................................................. 9
METHODS ……………............................................................................. 9
Study Design ……………………………………………………………………... 9
Study Population and Eligibility Criteria ……………………………………. 10
Sampling Process ……………………………………………………………….. 10
Data Collection Process ………………………………………………………... 11
Variables Definition ……………………………………………………………... 12
Measurements and Data Sources …………………………………………….. 15
Sample Size ………………………………………………………………………. 15
Statistical Methods ……………………………………………………………… 16
PRELIMINARY DATA ………………………………………………………….. 17
EXPECTED RESULTS ................................................................................ 20
STUDY TIMELINE AND HUMAN RESOURCES ................................................ 19
ETHICAL ISSUES ....................................................................................... 19
BUDGET AND MATERIAL RESOURCES ……………………………………….. 20
EXPECTED PUBLICATION AND PRESENTATIONS …………………………….. 21
BIBLIOGRAPHIC REFERENCES ……………………………………………….. 22
2

3. SUMMARY
INTRODUCTION: Hypertension is a serious problem of public health since it affects more then 50% of the
Portuguese population above 45 years. Lack of hypertension control is strongly associated with stroke
mortality and acute myocardial infarction, two leading causes of death and morbidity in Portugal. Among
the determinants of failure to control blood pressure, non-adherence and clinical inertia assume major
relevance. Cultural and socio-economic factors and health services access and utilization are critical
aspects underlying non-adherence and clinical inertia. These issues become even more complex when it
comes to hypertensive immigrants, due to the specifics involved in social integration, the migration
phenomenon and the own ethnicity. Both migrant and non-migrant populations are followed at primary
care level, where a strong patient-physician relationship and an integrated management of multiple
chronic diseases are a challenge to physicians. Longitudinal studies are the best approach to evaluate
medication adherence and therapeutic inertia dynamics, providing a better understanding on determinants
able to be intervened.
SPECIFIC AIMS: a) examine potential determinants of medication adherence and therapeutic adjustment;
b) identify multidirectional relations between adherence, inertia and the blood pressure control; c) identify
sub-groups, in each cohort, with high risk of uncontrolled hypertension related to poor adherence and/or
clinical inertia.
STUDY DESIGN: Observational, population-based prospective cohort study of medicated hypertensive
patients, followed at Primary Care Health Centres (PHCC) of the Lisbon Health Region, will be stratified to
two different cohorts, according to their status as immigrants or native.
METHODS: The sampling process will follow a multistage approach, by clusters, aiming to draw a
representative sample from the native and immigrant population who accesses primary care centres in
Lisbon, and their physicians. The final sample will be constituted by 1090 immigrants’ patients from African
Portuguese Speaking Countries and 1090 native medicated hypertensive patients. The inclusion criteria
will be verified through SINUS information system, by asking their physicians and during a phone interview
with the patient. The follow-up period will last for 18 months, and data collection will be performed by face-
to-face and phone interviews. The enrolled participants’ physicians will be asked to fulfil a questionnaire
after each medical appointment. Data collected will allow a longitudinal analysis by using the software
SPSS and R.
EXPECTED CONTRIBUTIONS: With a prospective evaluation of medication adherence and clinical
inertia, it will be identified the impact of key factors such as access and continuity of health care, the
patient beliefs regarding hypertension and antihypertensive medication and the patient-physician
relationship, and of key moments, such as a new medical appointment and time between appointments.
All these results will provide evidence for interventions and recommendations on hypertension
management. Also, by assessing both patients and physicians and their relationships, this study will be
able to examine the value of continuity and personalized care, which are specific values of Primary Health
Care. As we have preliminary results, we will be particularly interested in proposing and testing
interventions aiming to improve high blood pressure control and anti-hypertensive adherence.
KEYWORDS: Hypertension, Medication adherence, Clinical inertia, Migration
3

4. RESUMO
INTRODUÇÃO: A hipertensão arterial (HTA) é uma doença crónica que atinge mais de 50% da população
portuguesa acima dos 45 anos. O não controlo da HTA está fortemente associado ao acidente vascular
cerebral e ao enfarte agudo do miocárdio, identificados como as principais causas de morte e morbilidade
no nosso país. A não adesão e a inércia terapêutica têm sido apontadas como dois determinantes major do
não controlo da HTA. Sendo multi-dimensionais, ambas estão relacionadas com factores culturais e sócio-
económicos e com o acesso e utilização dos serviços de saúde, entre outros determinantes. Estes factores
tornam-se ainda mais complexos nos imigrantes hipertensos, devido às características próprias da
integração social, do fenómeno migratório e da própria etnia. Os cuidados de saúde primários acompanham
ambas as populações, imigrante e não-imigrante, colocando exigências ao nível da relação médico-doente
e continuidade de cuidados, bem como na adequação dos cuidados de saúde para as várias doenças
crónicas que o doente apresenta. Para compreender o impacto destes factores no controlo da HTA são
recomendados estudos longitudinais sobre a dinâmica da adesão e a inércia terapêutica. Da identificação
destes factores poderão surgir estratégias de intervenção para melhoria do controlo da HTA.
OBJECTIVOS: a) descrever os determinantes da dinâmica da adesão terapêutica e da mudança
terapêutica; b) analisar a relação multidireccional entre adesão, inércia terapêutica e controlo da HTA; c)
identificar sub-grupos, em cada coorte, com elevado risco de não controlo da HTA relacionado com a não
adesão e/ou inércia terapêutica.
DESENHO DE ESTUDO: observacional analítico, prospectivo e de base populacional, de 2 coortes de
imigrantes e não imigrantes, com HTA medicada e seguidos nos Cuidados de Saúde Primários da Região
de Saúde de Lisboa.
MÉTODO: O processo de amostragem será multi-etápico, por conglomerados, pretendendo-se uma
amostra representativa da população imigrante e não imigrante que acede aos cuidados de saúde
primários, bem como dos seus médicos de clínica geral e medicina familiar. A amostra final será
constituída por 1090 doentes imigrantes oriundos dos Países Africanos de Língua Oficial Portuguesa e
por 1090 doentes de naturalidade portuguesa com HTA medicada. Os critérios de inclusão serão
verificados através da informação obtida no sistema de informação SINUS, por questionário aplicado aos
médicos e durante uma entrevista telefónica com cada potencial participante. Os doentes de ambas as
coortes serão seguidos durante 18 meses, com recolha de informação por realização de entrevistas
presenciais e telefónicas. Será pedido aos médicos que preencham um formulário depois de cada
consulta com um dos doentes participantes no estudo. A análise dos dados recolhidos será feita com
recurso a modelos de estatística adequados, utilizando os softwares estatísticos SPSS e R.
CONTRIBUTOS ESPERADOS: A avaliação prospectiva da adesão e inércia terapêutica irá permitir a
identificação de factores-chave que possam ser alvo de intervenção, como o acesso e a continuidade de
cuidados de saúde, as crenças sobre a HTA e sobre a medicação e a relação médico-doente; e eventos-
chave, como uma nova consulta médica e o tempo entre consultas. Os resultados do estudo darão
suporte científico para estabelecer recomendações no controlo da HTA. Além disso, na medida em que o
estudo recolhe informação do doente, do médico e da relação entre ambos, será possível avaliar o valor
de cuidados de saúde continuados e personalizados, como defendido para os Cuidados de Saúde
Primários. Na presença de resultados preliminares, é de particular interesse propôr e testar intervenções
que melhorem a adesão à terapêutica e controlo da HTA.
PALAVRAS-CHAVE: Hipertensão, Adesão à terapêutica, Inércia terapêutica, Imigração e saúde.
4

5. BACKGROUND
Cardiovascular diseases are the main cause of death in Portugal, with a mortality rate
among the highest in Europe and the World1. Furthermore, ischemic heart diseases and
cerebrovascular are the third and fifth highest causes for potential years of life lost in Portugal.2
Moreover, international studies showed immigrants are more vulnerable to the effects of
hypertension, in particular with higher prevalence, severity and risk of premature hypertension
by ethnic group, which has been reflected in the differences in morbidity and mortality.3, 4
After age, hypertension is the highest attributable risk factor for cardiovascular diseases,
and it presents a very high prevalence in Portugal. In 2003, a national population-based study
detected hypertensive blood pressure levels in 42.1% of the 5023 adults examined.5 It has been
estimated that 40% of acute myocardial infarction or stroke is attributable to hypertension6. Even
mild or borderline hypertension has been showed to increase stroke’s incidence7. In contrast
with age, hypertension is amiable to prevention and control. This fact justifies the emphasis
given by the Portuguese National Health Plan (NHP) for its prevention and control.8
Also, given the high prevalence of hypertension in the Portuguese population, the National
Program for Prevention and Control of Cardiovascular Diseases recognizes that the control of
high blood pressure is a major objective for the improvement of cardiovascular mortality.9 These
objectives should be achieved by improving the “(…) diagnosis, treatment, follow-up of
hypertensive patients, medication adherence, self-care and self-control of hypertension and
associated risk factors”,10 and by recommending that “(…) scientific studies concerning the
prevalence, treatment and control of hypertension in Portugal should be developed.”11
Although effective antihypertensive treatments have been developed in the last decades, studies
have showed that 60-80% of medicated hypertensive patients do not achieve normal blood
pressure levels.12 A 2003 population-based national study showed that, among the Portuguese
medicated hypertensive patients, only 28.7% had normal blood pressure levels. This value is in
agreement with other international studies and surveys.13
Medication adherence and clinical inertia are key factors for hypertension control
Among the causes of failure to control hypertension, poor adherence and clinical inertia are
top high because of their impact and frequency.14 Adherence has been defined as “the extent
to which a person’s behaviour - taking a medication, following a diet (…) corresponds with
agreed recommendations from a health care provider”. Studies on medication-taking behaviour
have identified low adherence as a primary cause of inadequate control of blood pressure
5

6. (BP) and for having a higher risk of developing complications from coronary heart disease.7, 15
The best available estimates are that poor adherence to therapy contributes to lack of good
blood pressure control in more than two-thirds of people living with hypertension.7
Also, "medication adherence is a dynamic parameter that is not stable over time".16 For instance,
patients with variable adherence often improve compliance around the time of a scheduled clinic
visit but declines thereafter.17 Other key events related to adherence dynamic are acceptance,
representing if whether or not the patient ever starts the dosing regimen, and persistence,
defined as the time between the first and the last dose. Non-acceptance is less studied but it is
recognized by clinical experience,15 while studies on short persistence have pointed out that,
within first year prescription, up to half of newly diagnosed patients quit their antihypertensive
medication.16 All these medication taking parameters will be comprehensively examined during
this study. 18
Antihypertensive medication intensity is another main determinant of blood pressure
control.19 An interest finding is that, in chronic diseases, the problem isn't usually prescribing the
wrong drug but “failure to initiate or titrate medications until important evidence-based clinical
goals are reached”.20 This failure may lead to potentially preventable adverse events, disability,
death, and excess medical care costs.21 Regarding high blood pressure control, it is pointed out
the need to (1) recognize lack of control and (2) initiate and/or intensify treatment until
therapeutic goals are reached.22 Also, hypertension management guidelines reinforces that “the
effective and timely titration to BP control requires frequent visits in order to timely modify the
treatment regimen in relation to BP changes”.23 Despite these recommendations, clinical inertia,
defined as “an office visit at which no therapeutic move was made to lower blood pressure of a
patient with uncontrolled hypertension”24 has a major impact on blood pressure control in
hypertensive patients receiving regular care: a recent cohort study concluded that reducing
clinical inertia would allow to control increased blood pressure in additionally 20% of
hypertensive patients.19 To better evaluate clinical inertia, a sufficient time window should be
considered, to encompass several clinical visits. Furthermore, factors related to physician,
patient and the clinical visit should be considered, such as insufficient time with the patient and
lack of physician training and proactive care.25 Our study will include such design and
longitudinal data collection, to be able to examine and interpret these factors.
Migration, cultural and socio-economic characteristics as challenging factors for
hypertension control
Control and adherence to hypertension medication are complex and multidimensional. We
hypothesize that cultural and socio-economical factors, crucial to the understanding of
hypertension and adherence to anti-hypertensive treatment, and well to the two-way interaction
6

7. with health care services, are major determinants for the control of a chronic disease, such
as hypertension. Some of the factors associated to the nature and complexity of migration –
such as individual lifestyle and cultural and environmental conditions – may influence the
adherence to medication in immigrants. We aim to understand how these possible differences
affect the adherence to hypertensive medication, blood pressure control and clinical inertia, by
comparing eventual inequalities among immigrants to non-immigrants.26 Nevertheless, little is
known about migration as a health determinant and this topic has been neglected in the
scientific literature. In Portugal, we have found no published studies about adherence and
control of hypertension in immigrants.
It has been demonstrated that African Americans were more likely to have inadequate blood
pressure control when compared to whites.27, 28
Moreover, African were more aware of their
hypertension and more likely to be on treatment if aware of their diagnosis but among those
treated for hypertension, they were less likely to have their blood pressure controlled.29 The
reasons given to explain the poorer hypertension control in different races include genetic
factors, lower aggressiveness of treatment, factors related to lifestyle, diet and stress, side
effects acceptance and access and use of health care.29
Regarding medication adherence, African Americans were more likely to be non-adherent, to
perceive hypertension as more serious and to report increased side effects than whites, with
these factors being related to poorer blood pressure control.27 Non-adherence was shown to be
associated with a lack of a primary care physician and having blood pressure checked in an
emergency room.30 Adherence WHO Report states that race is frequently a predictor of
adherence, regardless of whether the members of a particular race are living in their country of
origin or elsewhere as immigrants. Often, cultural beliefs, fear of discrimination or being
distrusted by medical profession are the reason behind these racial differences.7
All these factors challenge hypertension control, health care and clinical practice. By comparing
immigrants and non-immigrants with high blood pressure, we will be able to better
understand the impact of socio-cultural characteristics, health care utilization and other
important factors in blood pressure control and medication adherence.
Our cohort of immigrant will be restricted to Portuguese Speaking African Countries. Regarding
the lately national migration statistic (with age information by country of origin),31 only migrants
from the Portuguese Speaking African Countries present a considerable number of individuals
above 40 years of age (25%). The great majority of migrants from Brazil and Ukraine (two of the
ten top origin countries) have less than 40 years of age. In fact, migration flows from these two
countries are more recent than from the African Countries.
7

8. Studying only African migrants is a limitation, but we believe that our findings could contribute for
relevant insights concerning barriers to blood pressure control in other minority groups and in the
general population. As we stated, the prevalence, severity and impact of hypertension are
increased in blacks, and therefore studying African migrants will allow us to better understand
those elevated risks.
Purpose and advantages of the current study proposal
Hypertension, as a paradigm of a chronic disease with enormous public heath impact, is a
particularly important social, disease and health care model to understand chronic disease
control and management. Including disadvantageous populations, such as immigrants, will
emphasize disease care areas that are fundamental to chronic disease control and
management.
This study will closely follow, for 18th months, a cohort of immigrants and non-immigrants,
allowing measuring and characterizing complex and dynamic phenomena which are
major determinants of blood pressure control, such as patient adherence to medication,
health care utilization and clinical inertia. Moreover, this study will characterize the care of
hypertension at the primary-care level, which will provide fundamentals data and insights
regarding the impact of primary care in the control of chronic diseases, such as hypertension.
Our team encompasses experienced and knowledgeable researchers, which have lead and
participated in community and primary-care based studies on cardiovascular disease,
medication adherence and health of migrants. This study will allow our country to participate in
international forums and networks were research, clinical care and public health policies for
chronic diseases, primary care, public health, health of immigrants and hypertension.
8

9. SPECIFIC AIMS
We will follow two cohorts of medicated hypertensive patients attending primary health care
clinics, one of immigrants and the other of non-immigrants, in order:
1. To compare migrants and non-migrants concerning the prevalence of controlled
hypertension, antihypertensive medication adherence, patterns of health services
utilization and approaches to hypertension control, adjusted for age, comorbidities, socio-
cultural and economical characteristics.
2. To examine potential determinants of medication adherence and therapeutic adjustment.
In particular, these will be related to:
a. Hypertensive disease, including severity and co-morbidities
b. Therapy, namely pharmacological and non-pharmacological approaches
c. Health Services, including access, patient-physician relationship and health
system utilization
d. Socio-economic aspects
e. Patient beliefs and attitudes towards hypertension and therapy
3. To identify multidirectional relations between adherence, therapeutic change, and blood
pressure (BP) control. We will identify situations of clinical inertia. We will test the
following hypotheses:
a. Therapeutic change is associated with medication adherence
b. Low adherent patients have a higher probability of uncontrolled BP, inducing
cyclic therapeutic change until higher dosages compensate non-adherence
c. Therapeutic change is determinant to BP control in high adherent patients, but not
much so in low adherent patients
4. To identify sub-groups in each cohort with high risk of uncontrolled BP related to poor
adherence and/or clinical inertia.
METHODS
STUDY DESIGN
This is an observational population-based prospective cohort study. Medicated hypertensive
patients, followed at Primary Care Health Centres of the Lisbon Health Region, will be stratified to
two different cohorts, according to their status as immigrants or native.
9

10. STUDY POPULATION AND ELIGIBILITY CRITERIA
Study participants will:
1) have a clinical record at Primary Health Care Centres from the administrative health
region of Lisbon;
2) have a clinical diagnosis of high blood pressure, as stated by the physician, or recorded in
the clinical medical record;
3) currently be taking antihypertensive medication, as indicated in the clinical medical record,
and confirmed during a visit to the participant;
4) have had their last clinical visit at least six months ago;
5) be aged between 40 and 80 years, included;
6) be responsible for taking their medication;
7) be able to be contacted, with an active phone number and address registered in the
primary health care centre information system;
8) be able to and consent in participate on the study.
We will exclude from this study subjects who are:
1) Institutionalized or those who depend on others to take the medication;
2) Patients with cognitive disorders such as dementia and schizophrenia, as indicated in the
clinical record or perceived during the interview.
3) Having plans to move from the Lisbon Health Region for more than consecutive 4
months within a 18th months period.
4) Patients unable to be contacted by telephone, after 10 attempts, in alternate days, at
different periods of the day.
In this study, immigrants are defined as subjects who were born in Portuguese Speaking African
Countries (Angola, Cape Verde, Guinea Bissau, Mozambique or Sao Tome and Prince), and
have arrived to Portugal after 1980. For the non-immigrants’ cohort, patients must have been
born in Portugal.
SAMPLING PROCESS
The sampling process will follow a multistage approach, by clusters, aiming to draw a
representative sample from the native and immigrant population who accesses primary care
centres in Lisbon Health Region.
a. Sampling of Primary Health Care Centres (PHCC)
Ten, out of 45 PHCC from Lisbon’s Health Region will be randomly selected. All selected PHCC’s
directors will be invited to participate, and any eventual refusal will be replaced by a new PHCC
randomly selected by the same process.
10

11. b. Within PHCC sampling of eligible subjects
For each PHCC, a list of all eligible users will be obtained from SINUS information system
managed by The National Health System Central Administration (ACSS). All eligible users will
be stratified in two lists (natives and non-natives) according to the location of birth (Portugal vs.
Portuguese Speaking African Countries).
c. Within PHCC sampling of participating physicians
Individual will be sequentially drawn from both lists. First 5 physicians reaching 75 users in each
of both cohorts will be selected and invited to participate in the study. Any eventual refusal of
participation by the physician will lead to the next physician reaching the same criteria.
d. Identification of medicated hypertensive patients
Potential medicated hypertensive patients will be identified by asking theirs physicians to
indicate those among the selected subjects. We have shown this identification process to be
superior, when comparing to telephone interview or reviewing the medical record32. Further
selection criteria will be assessed by phone interview.
DATA COLLECTION PROCESS
Data will be collected from following sources and times indicated in table 1.
The follow-up period will last for 18 months, during which it is expected to establish a continuous
relationship between the study participants and the research team by:
(1) Face-to-face interviews each 6 month (4 by participant in 1.5 years of follow-up);
(2) Phone interviews at 3, 9 and 15 months (3 by participant in 1.5 years of follow-up).
This frequency is expected to contribute to keep participants committed during the study and to
clarify any question that may arise by the participants.
11

12. TABLE 1. Data collection sources and periods.
DATA COLLECTION VERIFICATION AT FOLLOW-UP
INSTRUMENTS AND SOURCES OF ELEGIBILITY BASELINE 3M 6M 9M 12M 15M 18M
Patients’ eligibility form (to be fulfilled by the
physician) X
Patients’ eligibility questionnaire (to be fulfilled
during phone interview) X
Physician’s questionnaire X X X
Patients’ baseline questionnaire (face-to-face) X
Patients’ baseline questionnaire – immigrant cohort
(face-to-face) X
Clinical records’ form X
Social Support Questionnaire (SSQ6) X X X
Hospital Anxiety and Depression Scale (HAD) –
Portuguese version X X X
EUROPEP – Portuguese version X X
Beliefs about Medicine Questionnaire – General
and Specific (BMQ) – Portuguese version X X
Illness Perception Questionnaire (IPQ) –
Portuguese version X X
Patients’ follow-up questionnaire (face-to-face) X X X
Patients’ follow-up questionnaire (telephone
interview) X X X
Physicians’ follow-up form During each appointment.
Patients’ BP self-measurement and medication
adherence diary X X X X
Physicians’ participation consists in fulfilling
(1) A formulary per visit of the enrolled patients, with information about BP values and
changes in therapy.
a. The questionnaires will be annexed to clinical processes and collected monthly.
(2) A mid and final questionnaire regarding attendance to training courses and congresses
related to hypertension, as well as knowledge, attitudes and decision making regarding
management and experience with hypertensive patients.
VARIABLES DEFINITION
a. Outcome measures
Blood pressure (BP)
Blood pressure record will be collected by three sources of information: (1) patients’ clinical
records and (1.a) form filled by its physicians at each visit, (2) ambulatory BP, in a subgroup of
randomly selected patients, and (3) home BP, performed at all the face-to-face interviews
12

13. (baseline and follow-up period). BP will be measured as a continuous variable and its
classification will be according to 2007 ESH-ESC Practice Guidelines for the Management of
Arterial Hypertension.
Adherence to antihypertensive pharmacological therapy
Adherence will be evaluated as a time-changing parameter, which includes (1) acceptance (in
naïve medicated patients), (2) compliance and (3) persistence. A patient will be classified as
adherent if he accepts to take the prescribed medication, maintains the treatment during the
study period and presents compliance level of 80% or higher.
(1) Acceptance is defined has a dichotomous variable, assuming that a naïve medicated patient
accepts medication when it continues taking it for more than one month.
(2) Persistence is also defined as a dichotomous variable, assuming that a patient persists with
its medication when that is taken until the physician suspends it or the end of study period.
(3) A multi-method approach will be taken in order to access compliance, based on pharmacy
record and self-report:
• At the baseline interview, all the non-naïve patients will be submitted to the following
questions33: “People miss taking their medications for many reasons. Do you have
medicines for which you sometimes miss taking a dose? (..) How many doses might you
have missed in the past 10 days?” (Portuguese) “As pessoas podem falhar os seus
medicamentos por muitas razões. Há medicamentos para os quais, por vezes, falte a
toma de um ou mais comprimidos?” (....) “Nos últimos 10 dias, quantas tomas deve ter
faltado?” These questions had a specificity of 69.8% and a sensitivity of 80%, giving an
overall accuracy of 74.5%, when compared to pill count.33
• All participants will be requested to keep their pharmacy receipts for the duration of the
study period (18 months). This is usual practice as they allow taxes return. Compliance
will be defined as Medication Possession Ratio: sum of the days' supply of medication
divided by the number of days between the first fill and the last refill plus the days' supply
of the last refill. The accuracy of this methodological approach will be defined in a
previous validation study, assuming pill-count as the gold-standard.
Clinical inertia
We will use the O’Connor PJ et al. definition of clinical inertia. Newly added antihypertensive
therapy and increase in the dose of current antihypertensive therapy will be considered
therapeutic changes. Target blood pressure is assumed to be <140/90 mmHg (or <130/80 in
diabetic patients), according to 2007 ESH-ESC Practice Guidelines for the Management of
Arterial Hypertension. Therapeutic change is designated as timely when it occurs within 6 month
from the date of a clinical visit.
13

14. b. Predictors variables
The role of several variables – socioeconomic, health system and health care team, high BP,
treatment and patient-related factors – as determinants of adherence dynamic and therapeutic
change will be collected at baseline and throughout the study. This research team is
experienced in collecting such data and applying these questionnaires, as it has been happening
in other studies.
Socioeconomic-related factors
Patients’ baseline questionnaire will allow collecting information regarding socio-demographic
characterization (age, sex, ethnicity, Graffar scale), professional status and income, social
support networks (assessed with Social Support Questionnaire SSQ6), marital status,
educational degree (number of school years concluded). For immigrants, the level of
acculturation will be assessed through the Vancouver index.
Hypertension-related factors
From the patients’ clinical medical record, data will be collected regarding the time since the
diagnosis of hypertension, its aetiology and grade (according to European Guidelines); co-
morbidities included in Charlson Co-morbidity Index34 and lipid disorders. At the baseline
35
interview, the Portuguese version of the Hospital Anxiety and Depression Scale (HAD) will be
applied to all patients enrolled in the study. Cardiovascular risk factors will also be identified at
the baseline interview: alcohol consumption, smoking habits and physical activity practice will be
measured according to Portuguese National Health Survey methodology; height and weight will
allow the calculation of the body mass index.
Treatment-related factors
Antihypertensive medication will be assessed each medical appointment throughout the study by
means of a simple, one-page form that the physician will fulfil at the end of each appointment.
Data will be also collected / confirmed at each face-to-face or telephone interview. These data
will pertain to prescription details and allow the computation of the medication’s expenditure.
During face-to-face interview, further information will be collected regarding the patient
involvement in decision’s making, perceived self-efficacy and side-effects, use of over-the-
counter medicines and non-pharmacological treatments.
Health system and health care team-related factors
During the patients’ baseline interview, the Portuguese version of EUROPEP will be applied to
access the patients’ satisfaction with primary health care system, including the patient-physician
relationship.36
14

15. A questionnaire applied to the enrolled physicians will collect information concerning training and
practice in hypertension control, such as, years of clinical practice, enrolment in training
programs on hypertension management, the physician criteria for initiating and intensifying anti-
hypertensive medication and the adoption of guidelines. Other information as needs on
information concerning the management of hypertension, and problems faced when prescribing
antihypertensive medication will also be accessed.
Patient-related factors
Patients’ knowledge, attitudes, and lay beliefs about hypertension will be obtained during a face-
to-face interview with the application of Beliefs about Medicine Questionnaire – General and
Specific (BMQ)37 – and Illness Perception Questionnaire (IPQ)38.
MEASUREMENT AND DATA SOURCES
Instruments will be pretested and interviewers will have specific training to avoid systematic
errors. Test-retest reliability will be performed in a group of randomly selected patients, being
expected an inter-ratter agreement statistic (Kappa) ≥ 0.85. Adjustment and new testing process
will be conducted to those variables/questions in which Kappa < 0.85. A Manual of Procedures
(or Operations Manual), including definitions and quality control procedures, will be developed
and tested during the pilot study.
SAMPLE SIZE
Assuming medication adherence as 80% or more of expected drug intake, a difference of ± 5%
may be detected with a sample size of 907 among the two cohorts (total sample size of 1814).
With this sample size, 907 participants per cohort, and given a statistical power of 80%, it will be
possible to detect relative’s risks of 1.18 or more, or 0.85 or less. For this sample size a
difference among two continuous pair of variables will allow a high power to detect differences.
For instance, to detect differences of blood pressure levels among two groups we will be able to
detect 2 mmHg among two groups (assuming a standard deviation of 5mmHg in each group) in
98.9% of the times. Therefore this samples size will allow powerful multivariate models, even
more as repeated measures will be taken.
To account for lost to follow-up during the study, the total calculated sample size will be
increased in 20%. Therefore, the final sample size will be of 2180 subjects, that is, 1090 per
cohort.
15

16. STATISTICAL METHODS
Descriptive and inferential statistics will be performed. 95% confidence intervals will be
estimated for parameters of interest and a 5% significance level will be adopted for all statistical
hypotheses tests. Analysis will be performed using SPSS and R software. A careful data
inspection, cleaning and quality assurance phase will precede statistical analysis.
Accordingly to the study main objectives:
1) TO COMPARE MIGRANTS AND NON-MIGRANTS CONCERNING THE PREVALENCE OF CONTROLLED
HYPERTENSION, ANTIHYPERTENSIVE MEDICATION ADHERENCE, PATTERNS OF HEALTH SERVICES
UTILIZATION AND APPROACHES TO HYPERTENSION CONTROL, a description of both cohort will be
done, using categorical, parametric and non-parametric descriptive statistics, as appropriate.
Prevalence of controlled hypertension will be described according to relevant socio-
demographic variables (age, sex, education, economic status) for both groups and 95%
confidence intervals will be computed according to the F distribution. Relevant socio-
demographic and economical aspects, comorbidities scores and other clinical information (for
instance, number of years with hypertension), will be compared among migrants and non-
migrants, using chi-square tests for categorical variables, student t-test for parametric or
Wilcoxon rank sum test for non-parametric continuous variables, as appropriate. Non-migrants
and migrants will be compared regarding dichotomous variables, such as frequency of
controlled hypertension, percentage of subjects adherent to antihypertensive medication, etc.,
using logistic regression modelling, adjusted for age, comorbidities, socio-cultural and
economical aspects.
2) TO EXAMINE POTENTIAL DETERMINANTS OF MEDICATION ADHERENCE AND THERAPEUTIC
ADJUSTMENT bivariate and multivariate methods will be used. Bivariated association will be
tested using chi-square tests, Fisher Exact Test and binary logistic regression. Multivariated
binary logistic regression will be performed to check which factors simultaneously relate with
outcome variables.
3) TO IDENTIFY MULTIDIRECTIONAL RELATIONS BETWEEN ADHERENCE, THERAPEUTIC CHANGE, AND
BLOOD PRESSURE CONTROL bivariate and multivariated data analysis will be performed.
In bivariated analysis, when adherence or therapeutic chance is considered an dependent
variable, the analysis is identical to the recommended above for potential determinants
determination. Of particular interest here is the situation when blood pressure is considered
as the variable to be explained (as dependent variable): in such case t-tests and ANOVA will
be used, as well as their non-parametric equivalent Mann-Whitney and Kruskal-Wallis tests.
Multivariated approaches, aiming at identifying multiple factors and variables simultaneous
associated with blood pressure will consist of multifactorial ANOVA (General Linear Models)
and Multilevel Models.
In fact, Multilevel Models (also known as hierarchical linear models, generalized linear mixed
models, nested models, mixed models, random coefficient, random-effects models, random
parameter models, or split-plot designs) are statistical models of parameters that vary at
16

17. more than one level and are known to be a good very general framework to discover how
differences between studies in treatment implementations, research methods, subject
characteristics, and contexts related to treatment effect estimates within studies39. These
models can be seen as generalizations of linear models, although they can also extend non-
linear models.
Multilevel models are known to be very flexible but are also known to be sensible to presence
of missing data and low number of information waves (number of time points at which time
points were collected). In our study a high number of missing values is not expected. If
number of records with missing information is small, listwise selection/deletion will be
considered; otherwise data imputation or multiple imputation standard techniques will be
considered. In this latter case, sensibility analysis will be performed (analysis with and
without imputation) and reported.
4) TO IDENTIFY SUB-GROUPS IN EACH COHORT WITH HIGH RISK OF UNCONTROLLED BLOOD PRESSURE
RELATED TO POOR ADHERENCE AND/OR CLINICAL INERTIA profiles will be generated using
multivariate exploratory data techniques: Cluster Analysis and Q Factor Analysis will be
conducted.
PRELIMINARY DATA
Our research team has experience in working with the primary care setting; examining
antihypertensive medication adherence; and studying immigrants’ health. In this section we
describe preliminary work and results relevant to demonstrate our proficiency and how this study
builds on previous studies.
Immigrants access to primary health care40
There is a lack of studies concerning the health, health care access and equity for the
immigrant communities'. In 2007, our research team developed a study about the
"Evaluation of Health and Health Assessment of African and Brazilian Immigrants in
Portugal" with the objectives of characterizing the health, the access to health care and the
health determinants of the African and Brazilian communities living in Lisbon and Setubal
Districts, and comparing theses data with the data available from the general population
with the 4th National Health Survey.
Individuals were selected through a process of random simple cluster geographical
sampling with the help of GIS software (ArcGIS 9.1). The data collection was obtained by
teams of interviewers, most of them from the communities in study.
A total sample of 4508 individuals was surveyed, aged between 0 and 87 years old, 51%
were women. This population used mainly the National Health Service (86%). Within the last
three months, 24% have consulted once a doctor, 14% consulted 2-3 times, and 5%
consulted more than three times. The last consultation was mainly in the PHCC (61%).
17

18. Hypertension awareness, prevalence, control and treatment in Immigrants*
Furthermore, also in 2007, our research team conducted a study intituled: "Comparison
Between Self-Referred Hypertension and Blood Pressure Measurement in African
Immigrants and Brazilians", based on a sub-sample from the study described above. Blood
pressure measurements were obtained by trained observers using a validated OMROM
M6C sphygmomanometer. Additional information’s concerning hypertension and its
treatment was collected through a specific questionnaire, during an interview with an
interviewer from the same community.
The final sample was constituted by a total of 317 individuals, aged between 30 and 83
years old, 61% were women. Overall 45.6% had hypertension. Prevalence of hypertension
was higher among African (52.7%) than Brazilian (24.3%) (p<0.001).
Overall, 42% of hypertensive patients were aware of their diagnosis. Around 47% of those
with hypertension were medicated. Mean years of diagnosis is 11±10.8 and of medication,
10±9.6. Only 19% of hypertensive and 59.7% of hypertensive medicated achieved blood
pressure control.
Regarding our approach to study adherence the antihypertensive medication in the immigrant’s
cohort, these preliminary results show that hypertensive immigrants seem not to have limited
access to health care as they have frequent consultations in the PHCC (a great number had
consultations in the previously 3 months of the inquiry). This supports that sampling the
immigrant participants may be carried out in the same way as that for the non-immigrants.
How to identify medicated hypertensive patients at Primary Care Health Centres?
The answer to this question was possible with a previous study32 of 250 subjects followed at a
primary care centre of Lisbon’s Region, with age ≥ 40 years. To compare advantages and losses
of information, independent processes were applied: (1) physicians were asked to identify their
patients as with/without hypertension under medication, by answering a brief questionnaire, (2)
clinical records were consulted and (3) phone interviews were driven. With the study conclusion,
48% (120 patients) have medicated hypertension identified by, at least, one of the above processes.
The physician’s questionnaire allowed the identification of a larger number of medicated
hypertensive patients (74.2% of all medicated hypertensive patients) with fewer loss of information.
*
Unpublished data.
18

19. Study Timeline and Human Resources
Month Human
Task
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Resources
0. Study protocol and
Research team
choice of measures
1. Ethical Committee and
administrative Research team
permissions
2. Interviewers selection 2 Field
and training coordinators
3. Pilot study
2 Field
4. Database construction Coordinators
5. Validation of 2 Interviewers
compliance measure by 1 Informatic
pharmacy claims
1 Study
6. Sampling Process Coordinator
7. Recruitment of
medicated hypertensive 2 Field
participants Coordinators
8. Recruitment of primary 6 Interviewers
care physicians
9. Follow-up period 2 Field
(face-to-face interviews or
Coordinators
telephone interviews each
4 Interviewers
3 months)
10.Data analysis Research team
11.Publications and
divulgation of the study Research team
results
ETHICAL ISSUES
We will take in consideration the following ethical issues:
1. Health care data is sensible personal information. We will de-identify data such as name,
birthday, address and telephone contact. Patients and health care providers will be coded with a
unique non-identifying number. The database will have protected access (restricted access,
password-protected), and servers will be protected with state-of-art software firewalls and anti-virus.
2. Written informed consent will be requested to all participants: a copy of the signed informed
consent will remain with the participant. The right to leave the study at any time, and to have all data
erased, will be recognized. In order to infer external validity from the data analysis, a small set of
non-identifying data (e.g., gender, year of birth) will be used to compare consenting and non-
consenting subjects.
3. A permission from Protection Data Portuguese Authority (CNPD) will be required to use
centralized databases with individual data. This permission is particularly relevant since we will
collect sensible personal and clinical data. This research group is experienced in submitting similar
requests to CNPD.
A cross-sectional version of this study has already been approved by the Ethical Committee from the
Medical School of the University of Lisbon. Currently, it is pending a request for the modifications
related to the longitudinal design.
19

20. BUDGET AND MATERIAL RESOURCES
For an expected sample size of 2180 subjects (see sample size calculation), we anticipate the
following budget and material resources:
Amount Material
Item (Eur) Resources Description
Start-up costs
Consultant revision (including travel expenses).
Consultants 2500 Travel expenses
Includes 2 visits of 3 days.
Submission to the Ethical Committee and Portuguese
Ethical Approval 250
Data Protection Authority
Office material Pilot study for the validation of study methodology,
testing of the data collection and of the procedures
Pilot study 1500 Phone credits
manual, in 100 participants (50 per cohort), only at
Travel expenses baseline and one follow-visit at 3 months.
Database construction and testing, storage and
Database management 800 Server
protection.
Office material Contacts with the PCHCs and general physicians:
Implementation at Primary Care invitation to the PCHC directors; debriefing; invitation
500 Travel expenses
Health Centres (PCHC) to the physicians. Estimation of 4 visits for 2 persons
Phone credits to 14 PCHC at 4.5 Euros per visit.
Participant-related costs
Telephone contacts with GP's, during all study
Physicians' contacts 500 Phone credits phases (110 GP's, 3 visits per GP, 3 phone calls per
visit, 0,5 Euros per phone call)
Post expenses Appointment of face-to-face interviews + telephone
interviews (2180 participants, 4 visits per participant,
Participants' contacts 30000 3 phone interviews per participant, 3 phone calls per
Phone credits contact, 0.5 Euros per phone call) (2 letters per
participant, 0.5 Euros per letter)
Documentation 5500 Office material Paper questionnaires (~2.5 Euro/participant)
Staff and Analysis costs
Public transportation cards for 5 interviewers for 25
Traveling expenses 5000 Travel expenses
months, at 40 Euros per month.
5 part-time interviewers, working a mean of 6
Interviewers' part-time stipend 66000 Stipend
hours/day, for 22 months, at 600 Euros per month.
Statistical analysis performed by a team member and
Statistical Analysis & Report 2500
revised by an expert in longitudinal data analysis
30% time of a study coordinator, for 24 months, for a
Study coordinator 15000
full-time stipend of 2000 Euros/month.
30% time of a filed coordinator, for 24 months, for a
Field coordinator 10000
full-time stipend of 1400 Euros/month.
Participation and presentation in national and
Travel expenses
Publications and divulgation of international meetings;
2500
results Publications and divulgation of the study results in
Meeting registration
international and national peer-review journals.
sub-total 1 142550
Unexpected expenditures (15%) 21382.5
sub-total 2 163932.5
AIDFM (8%) 16000 Institution overheads.
IMP (10%) 18400 Institution overheads.
Total 198333
200 000
20

21. EXPECTED RESULTS, PUBLICATIONS AND PRESENTATIONS
It is expected to communicate the research’s potential contributions through publications in
international and national peer-review journals, and in international and national meetings
related to areas such as Public Health and Epidemiology, Cardiology, and Immigrant’s Health. In
these areas, the research’s foreseen contributions are
1- Clinical, Public Health, Care for Hypertensive patients, Primary-Care: (1) prevalence
of hypertension control, adherence to antihypertensive medication and clinical inertial; (2)
determinants of hypertension control, adherence dynamic and therapeutic change; (3)
implementation and compliance with current guidelines and recommendations; (4) profile
of the hypertensive patients at the primary-care;
We will be able to describe the dynamics of medication adherence according to
important key moments and factors concerning a chronic disease with major public
health impact. These key moments are, for example, a new appointment, attending the
emergency care or an adverse event. We will measure the impact of key factors, such as
patient-doctor relationship and continuity of care, time between appointments, and the
physicians’ criteria for intensifying therapy. All these results will provide insights to
elements which may be intervened, in order to improve the control of high blood
pressure. The importance of these results may be extended to other chronic diseases.
This study will be innovative since it will incorporate the information of both patients
and physicians. We will be able to understand how these two perspectives integrate
each other: for instance, we will be able to examine if a physician who easily intensifies
therapy associates with a more adherent patient; if physicians who like to treat
hypertensive patients are associated with patients who belief their antihypertensive
medication is effective; if physician who evaluate medication adherence and adverse
effects are more likely to have adherent patients. Moreover, this insight is of more value
as we will be including primary-care physicians, who are more likely to have long-term
relations with their patients, and to care about other chronic diseases of the same
subjects.
2- Epidemiology: (4) discussion of cohort studies methodology for multiple measurements
in chronic diseases; (5) measurement issues in medication adherence and clinical inertia
research; (6) measuring health care quality, equity to health care access, and ethnicity as
a variable in epidemiological research;
In Portugal it is not common to have longitudinal prospective studies, particularly at the
primary care level. These studies require a high level of organization and professional
management, along with a high-motivated team who will create and maintain a strong
commitment and relation with all participants and everyone else involved. We expect
21

22. that, in the course of this study, we will be able to make collaborations with other
researchers, so that we and other may take further scientific and clinical advantage with
this effort. Therefore, we expect that new projects will be created from these
opportunities. As we have additional preliminary results, we will be particularly interested
in proposing and testing interventions aiming to improve high blood pressure control
and anti-hypertensive adherence.
3- Immigrant’s health: (7) equity to health care access among immigrants and non-
immigrants; (8) discussion of the inclusion of ethnic minorities in health outcomes
research; (9) ethnic inequality in health status; (10) acculturation and health and
determinants for adherence in immigrants.
In Portugal there are few studies about migration and health and none about medication
or control of a chronic disease in migrants. As far as we know, this will be the first
longitudinal study with a prospective cohort of adult immigrants. A recent cohort
study was conduct with children with the objective of defining the prevalence of
immigrant children and to assess the children in their first months of life morbidity and
mortality.41 We expect a better understand of changes in health related to migration
status, which may lead to evidence-based measures regarding health services
organization and specific intervention programs.
We expect, during the next 2-3 years, to publish about 2 to 4 papers per year (total of 9-10
papers), both at national and international peer-reviewed journals. We estimate a similar number
of presentations at national and international meetings. This research unit is responsible for the
Master Degree in Epidemiology at the Lisbon’s University Medical School. This project should
provide enough scientific material for 2 master theses. Therefore, we anticipate the opportunity
to interest students in project and to present, during the next 2-3 years, about 1 seminar per year
concerning this study.
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