Implementation of DCP3 Strategies to Manage and Control Hypertension Among Hypertensive Patients in Pakistan: A Randomized Controlled Trial
Phase: NA
Conditions: Hypertension, Hypertensive Patients
Sponsor: Health Services Academy, Islamabad, Pakistan

i 
 
 
 
 
 
RESEARCH PROPOSAL TITLE: 
 
 
Implementation of DCP3 based Strategies to Manage and Control Hypertension 
among Hypertensive Patients in Pakistan: A Randomized Controlled Trial 
 
 
Submitted by: 
 
Subhana Akber 
PhD Public Health (2017) 
Health Services Academy, Islamabad 
 
 
Date of submission: 05th Spetember, 2019. 
 
 
 
Supervisor: 
Dr. Assad Hafeez 
PhD Public Health 
 
 
 

 
 
1. Introduction 
Hypertension is a clinical condition which refers to persistently raised pressure of blood in 
the vessels.(1) Since 1980s, there has been a reduction in the mean blood pressure (BP) level at 
population level. By 2010 however; still it was counted as the fourth highest risk factor for 
cardiovascular diseases (CVD) but then it became the highest risk factor attributable to disability 
adjusting life years (DALYs).(2) In low and middle-income countries, hypertension 
disproportionately affects the population which signals the weakness of health system. As 
hypertension is considered as a silent killer, it often undergoes unrecognized and leads to the 
development of major cardiovascular events. In addition, it also pertains to dietary and sedentary 
behaviors including excessive intake of salt in food, obesity and stressful life and environmental 
factors.(3) 
 
According to the findings of a meta-analysis, the quantifiable rise in lower-middle income 
countries was primarily due to aging and population growth. Approximately, 80% of global 
deaths due to cardiovascular deaths occur in lower-middle income countries(4) whereas; a 
significant decline has been experienced by high-income countries. The decline in high-income 
countries is mainly accredited to reduction in deaths from coronary heart diseases and stroke. 
Changes in population-level of risk factors, specific blood pressure control (BP) and effective 
antihypertensive treatment as well as management of hypercholesterolemia were the major 
attributable aspects of this success. However; with the exception of some regions of Africa, high 
blood pressure has been rated among five leading risk factors contributing to worldwide 
morbidity and mortality.(5) 
 
Globally, 9.4 million deaths per year are accounted for increased blood pressure and due to 
complications of hypertension alone.(5,6) An increased blood pressure is considered as the 
leading risk factor of mortality(5,7) however; an estimated 18 million deaths annually are 
attributed to cardiovascular diseases worldwide.(2,6) Heart diseases, stroke, renal failure, 
premature death and disability owing to hypertension contributes to the prevailing burden of 
cardiovascular diseases (CVDs) and therefore pose as an issue of public health concern.(6) The 

2 
 
findings from Global Burden of Disease study (2015) reports the burden from Eastern 
Mediterranean Region (EMR) due to cardiovascular diseases (CVD) which principally included 
stroke and ischemic heart disease. One-third of all deaths in 2015 were ascribed to 
cardiovascular diseases (CVD) alone. Amongst 22 countries of the EMRO region, Pakistan was 
ranked first for reporting 85.1% of total deaths due to cardiovascular diseases in the country. 
 
Despite the fact that majority of deaths owing to cardiovascular diseases occurred in low and 
middle-income countries. However; this decline in age standardized mortality rates have been 
observed since last 25 years which were mainly attributed to public health and preventive 
interventions.(8) For policy and health system perspective, cost-effective health interventions 
help to aid budgeting of national healthcare plans and strategies.(9) Some related interventions 
for the management of hypertension as per Disease Control Priorities (DCP3) includes initial 
screening by physicians, monthly visit and training of non-physician healthcare workers. Non-
physician healthcare workers can serve in task shifting and can contribute in increasing 
knowledge about cardiovascular risk, hypertension management and adherence to treatment 
particularly in low-resource settings.(5) 
 
Table 1: Interventions for the Primary Prevention of Cardiovascular Diseases in Disease 
Control Priorities 3rd Edition (Adapted)(5) 
INTERVENTIONS FOR MANAGEMENT OF HYPERTENSION 
A) 
Modifications of Risk factors through Life Style Changes 
i. 
Cessation of Smoking 
Smoking Cessation, Weight Loss 
ii. 
Exercise/Physical Activity 
iii. 
Dietary Modification 
Reduction in Salt Intake/Alcohol, DASH diet 
B) 
Pharmacological Treatments/Screening/Management 
i. 
Elevated Blood Pressure 
Regular check-ups, Recommended Target: 
140/90 mmHg 
ii. 
Hypercholesterolemia 
iii. 
Dyslipidemia 
iv. 
Diabetes 
C) 
Non-Pharmacological 
i. 
Behavioural Counseling 
Awareness, lifestyle modification and changes 
in diet and pattern 
 

3 
 
1.1 
The Research Problem 
Hypertension is a substantial public health concern and among major causes of deaths all 
over the world. It is a disease which is been termed as a “silent killer” that tends to cause 
premature mortality.(6,10,11) Approximately, more than 7 million deaths are accounted due to 
increased pressure of blood which reasons 12.8% of all causes of deaths in the world.(12) 
According to Global Health Observatory (GHO) data, the prevalence of increased blood pressure 
among men and women of age 18 years and above was 24% and 20%, respectively.(10) Risk of 
cardiovascular events such as coronary heart disease (CHD), ischemic heart disease (IHD) and 
stroke results in the presence of hypertension due to positive association. In addition to 
macrovascular complications, it can also result in number of microvasucular complications such 
as renal impairment, retinopathy and peripheral vascular diseases.(10) 
 
Managing and treating hypertension can cause a significant reduction in cardiovascular 
associated complications among hypertensive patients. Globally, a high prevalence of 
hypertensive patients can be attributed to the increase in population growth and aging. However; 
hypertension is 40% prevalent in low and middle income countries than in high income countries 
which is approximately 35% of their total population. Whereas; more men tend to have raised 
blood pressure as compared to women in all WHO regions.(12–14) 
 
A study was conducted in five countries including Pakistan to assess management of 
hypertension among 2185 patients in a clinical setting that focused on patient level factors. Rates 
of controlled hypertension were assessed as per the 2009 Reappraisal of the 2007 European 
Society of Cardiology/European Society of Hypertension (ESC/ESH) guidelines. Approximately, 
40% of the patients had controlled hypertension as per the guidelines. However; poor rates of BP 
control among patients was primarily linked to non-adherence to treatment, high salt intake and 
lack of understanding of importance of treatment along with co-morbidity.(15) The results of 
study recommended promotion of guidelines and implementation of strategies to improve BP 
control rate. 
 
In addition, non-pharmacological interventions including lifestyle modifications and dietary 
changes can help to reduce progression of hypertension and onset of cardiovascular diseases.(16) 

4 
 
There is extensive literature available eliciting role of healthcare professionals in hypertension 
management and control.(15–17) Other numerous studies are also available that focused on 
behavioural interventions using telemedicine and mhealth.(18,19) But sufficient and relevant 
evidence on physician’s engagement with hypertensive patients on a multi-component 
hypertension treatment and patients’ involvement into their self care and management of 
hypertension is though limited particularly in context of Pakistan.(20) Hence, this study aims to 
reduce blood pressure of hypertensive patients in three months to the recommended target of 
140/90 mmHg from the baseline at Armed Forces Institute of Cardiology/National Institute of 
Heart Diseases (AFIC/NIHD), Rawalpindi. 
 
 
 
 

5 
 
2. Literature Review 
Raised or persistent blood pressure level at 140/90mmHg or higher is defined as 
hypertension.(21) It is a wide known considered risk factor not only for cardiovascular diseases 
but for renal diseases as well. Hypertension is a risk factor for most, if not all, cardiovascular 
diseases and renal failure.(20) It is worth to repeatedly measure the blood pressure for the 
purpose of screening and diagnosis. New techniques of measuring the blood pressure such as self 
measurement using home or ambulatory blood pressure are bring extensively used for 
assessments during the treatment. It is however important to focus on blood pressure primarily to 
detect target organ damage, i.e. left ventricular hypertrophy (LVH) and renal effects.(22)The 
findings of a meta-analysis (2018) stated that the pooled prevalence of hypertension among 
Pakistanis was found to be 26.34% with higher prevalence among urban population (26.61%) 
than among the rural dwellers which was 21.03%.(11) 
 
Table 2: Comparison of Probability (%) of Dying Between Age 30 to 70 Years from any of 
Cardiovascular Disease, Cancer, Diabetes or Chronic Respiratory Disease from 2010-2016 
 
Year 
WHO Global* 
Eastern Mediterranean Region 
2016 
18.3 
22.0 
2015 
18.5 
22.3 
2010 
19.4 
23.5 
 
*Global Health Estimates 2016: Deaths by Cause, Age, Sex, by Country and by Region, 2000 2016. Geneva, World 
Health Organization, 2018; effective date on 05thApril, 2018. 
 
As indicated in Table 2, the probability of dying at the age of 70 years gradually decreased from 
2010 to 2016 as compared between WHO global regions versus East Mediterranean Region 
including Pakistan.(23)This necessitates implementation of effective public health interventions 
that has been found effective in low and middle income countries including Pakistan such as 
population-based intervention on hypertensive patients.(24) In this context, Disease Control 
Priorities, 3rd Edition is a project that is reviewed by policymakers and technical experts. It 
serves to provide evidence on economical and cost effective strategies in LMICs to address the 
burden of priorities diseases.(25)In addition, Table 3 shows global mortality from cardiovascular 

6 
 
events such as ischemic stroke, heamorrhagic stroke, hypertensive heart diseases and kidney 
diseases among both sexes of high income and low-middle income countries from 2000 to 
2016.(26) Although deaths from hemorrhagic stroke, hypertensive heart diseases and kidney 
diseases were reported higher in low-middle income countries during 2000 whereas; only 
hypertensive heart diseases and kidney diseases were also reported higher among high income 
countries during 2016. But the global burden of deaths from ischaemic stroke was significantly 
reduced in both high and low-middle income countries from 2000 to 2016.Worldwide, 
hypertension is one of the most important cardiovascular risk factor(6) which prevails due to 
increased longetivity as well as in the presence of contributing factors such as obesity, diabetes, 
salt intake, smoking, associated clinical conditions and other environmental risk factors. 
According to World Health Organization (WHO 2016), effective implementation of all of WHO 
“best buys” can help to save more than 169,000 lives.(27) This includes recommended 
interventions such as drug therapy, treating acute myocardial infarction (MI), acute ischemic 
stroke, managing diabetes etcetera.(28) Whereas, preventive efforts include regular check-ups, 
better diet (such as DASH diet), smoke cessation and physical activity as shown in Table 
1.(17,29,30) 
 
Table 3: Comparative Analysis of Global Mortality due to Cardiovascular Events between 
High and Low-Middle Income Countries 
 
 
 
Cause of Death 
High Income Countries 
(%) 
Low-Middle Income 
Countries (%) 
2016 
2000 
2016 
2000 
1. Ischaemic stroke 
16.8 
22.2 
16.3 
11.2 
2. Haemorrhagic stroke 
7.2 
10.3 
8.4 
7.0 
3. Hypertensive heart diseases 
1.4 
1.0 
1.3 
1.0 
4. Kidney diseases 
2.2 
1.6 
2.3 
1.5 

7 
 
3. Rationale of the Study 
The most common single risk factor for cardiovascular diseases is persistently high blood 
pressure. Incidence of hypertension is escalating in Pakistan with an estimated 18.9 - 29.2% of 
Pakistani adults are reported to be hypertensive.(11) According to a similar study conducted in 
Pakistan; almost 33% of individuals of age 45 years and above have hypertension.(20) Gender 
diversification reveals that an estimated prevalence of hypertension among males in Pakistan is 
reported to be 24.9% and in females the prevalence is reported to be 24.7%.(11,31) Whereas; 
among adults (age above 18 years), one in four is reported to be hypertensive along with 
smoking in Pakistan.(32) Consecutively, evidence also suggest that hypertension is more 
common among males than in females.(13,14) Furthermore, in Pakistan, every third adult over 
the age of 40 years is predisposed to a wide range of diseases where; nearly 50% of patients are 
diagnosed with hypertension, consequently.(33) It is however; essential for hypertension 
management and control that early screening may be done along with initiation of hypertension 
treatment and management to reduce incidence of cardiovascular diseases.(34,35) This study will 
contribute to existing evidence on managing hypertension as no reliable data till date exists on 
comparative strategies to manage hypertension in Pakistan.(20) Thus, it is substantially 
important to control blood pressure among hypertensive patients to avert cardiovascular diseases 
and related complications such as target organ and renal effects among patients.(22) 
Furthermore, this hospital-based study will serve as a test bed for the intervention’s effectiveness 
to be delivered in the community setting through trained workers.  
 
4. Aims and Objectives 
The aim of this study is to reduce systolic blood pressure to the recommended target of (SBP) 
≥140 mmHg among hypertensive patients registered in the trial. For primary prevention of 
cardiovascular diseases among hypertensive patients, it is important to early manage and treat 
hypertension which also helps to reduce the risk of developing coronary heart disease (CHD).  
Thus, the objectives of this study are as follows: 
 

8 
 
4.1. Primary Objectives: 
1. To conduct a formative study on hypertension management and control by including subject 
experts, cardiologists and patients. 
2. To test the feasibility, acceptability and adaptability of DCP3 interventions in the cultural 
context of Pakistan and modify it on the basis of findings of formative phase. 
3. To test the effectiveness of DCP3 interventions in reducing systolic blood pressure to the 
recommended target after three months of delivering the intervention. 
 
4.2. Secondary Objectives: 
1. To ascertain proportion of patients with adequate BP control at 03 months in both arms of 
the study. 
2. To calculate cardiovascular risk for each patient according to ACC/AHA 2013 guidelines. 
3. To assess each patient’s use of number of antihypertensive drugs, compliance to prescribed 
treatment and their self-rated health before and after the intervention. 
 
4.3. Hypothesis 
Hypertensive patients receiving the intervention will have a greater reduction in systolic 
blood pressure after three months as compared to patients in the control arm receiving the usual 
medical care. Moreover, patients in the intervention arm will have a higher proportion of 
controlled blood pressure, a high level of physical activity, weight loss and a greater reduction in 
salt intake as compared to the control arm at 03 months. The patients will manage and control 
their blood pressure after the completion of trial at 24 months. 
 
 

9 
 
 
5. Operational Definitions 
5.1. Hypertension 
It is defined as a condition in which sclerosis of vessels occurs due to persistent and 
increased pressure of blood. This also results in increased pumping of blood by the heart. 
Systolic blood pressure of ≥140 mmHg and diastolic blood pressure of ≥ 90 mmHg is termed as 
hypertension which can affect the overall health and well being of patients.(21) 
 
5.2. Uncontrolled Hypertension 
As per International Classification of Diseases (ICD-10 10-CM Diagnosis Code I10) 2019, 
“persistently high systemic arterial blood pressure. Based on multiple readings (blood pressure 
determination), hypertension is currently defined as when systolic pressure is consistently greater 
than 140 mm hg or when diastolic pressure is consistently 90 mm hg or more.”(36) 
 
5.3. Blood Pressure (BP) Control 
Blood pressure control will be considered when the systolic BP is less than or equal to 140 
mm Hg and the diastolic BP is less than or equal to 90 mm of Hg(37) at the end of the 
intervention and follow up in the intervention arm. 
 
 

10 
 
6. PHASE I: SOP (FORMATIVE RESEARCH) 
6.1. Study Objectives: 
The main objective of the formative phase is to enable the development of intervention 
comprising of DCP3 strategies for hypertension management and control for hypertensive 
patients. The specific objectives are as follows: 
 
1. To conduct a desk review on DCP3 interventions for hypertension management and control. 
2. To test the feasibility, acceptability and adaptability of DCP3 interventions in the cultural 
context of Pakistan and modify it on the basis of findings of formative phase. 
 
6.2. Research Questions: (Add RQ to dissertation) 
a. Who is the most appropriate healthcare personnel for delivering an intervention based on 
DCP3 strategies for managing and controlling hypertension among hypertensive patients 
in Pakistan? (Phase 1) 
b. Does a hypertension related intervention based on DCP3 strategies is acceptable among 
physicians or senior doctors or cardiologists? What are the key challenges in its 
applicability? Is it feasible in our local context? (Phase 2) 
 
6.3. Methodology: 
For the formative study, qualitative research methods will be employed to conduct a desk 
review analyze and its findings. To explore the feasibility, applicability and acceptance of DCP3 
based hypertension intervention, focus group discussion and in depth interviews with selected 
study participants will be conducted. A prior written and verbal consent will be obtained from 
the study participants by the principal researcher herself. Data will be collected after obtaining an 
ethical approval from the Institutional review Board of Health Services Academy (HSA). The 
following will be the key steps: 
 
A. Desk Review: 
A desk review will be conducted using PubMed, CINAHL and Google Scholar and 
literature available past five years will be selected for the review. The inclusion criteria 

11 
 
will comprise of DCP3 interventions or strategies to manage and control hypertension 
(Table 1). Specifically, for the non-pharmacological strategy which includes aspects of 
awareness, counseling, lifestyle modifications and changes in diet pattern to control and 
manage hypertension among hypertensive patients pattern; systematic reviews and 
randomized trials will be included for the literature search. The results will be coded into 
themes and review findings will be reported accordingly. 
 
B. Selection of Study Respondents: 
To test the acceptance of DCP3 based intervention on hypertension management and 
control, potential study respondents will be indentified in a sampling frame (Table 4). 
The study respondents will be included for qualitative interviews on hypertension, its 
management and control. Focus group discussion and in-depth interviews will be 
conducted to determine the feasibility and applicability of intervention among 
hypertensive patients. Furthermore, patient-focused topic guides will be developed on the 
non-pharmacological strategy based on DCP3 intervention. Subsequently, content of 
intervention will be developed based on the findings of qualitative interviews. Evidence 
suggests that a team-based care model is more effective in preventing CVDs and in 
reducing blood pressure. In addition, the team-based care model has also been found 
effective in communities when cost-effective interventions have been deployed im 
masses. Mainly, the team-based care model includes the patient, healthcare practitioner/ 
primary health care provider as well as nurses and pharmacists(38). Whereas; certified 
hypertension specialist, dieticians, medical assistants and social workers have proven 
contributing role in such team-based care model(39). For developing the intervention, 
following will be the potential study respondents: 
 
i. 
Subject experts who have been working for non-communicable diseases and / or 
involved in policy and decision making for health related priorities. 
ii. 
Cardiologists / physicians / senior doctors. 
iii. 
Pharmacist who are working in the hospital setting. 
iv. 
Nurses who are primarily involved with cardiac patients in OPDS and wards. 

12 
 
v. 
Patients with uncontrolled hypertension who are able to give consent without any 
organ damage or serious health condition requiring emergency care. 
 
C. Development of Topic Guides: 
A general topic guide on hypertension management and control will be prepared in 
English language which will be translated into local language Urdu. Initially, the guide 
will be prepared which will base on the gaps identified in the desk review. The guide will 
be further modified after collecting data from the identified study respondents for the 
formative phase. The format of the guide will include the procedure of obtaining consent 
from the study participants selected through convenience-based sampling technique. 
Their socio-demographic characteristics and contact details will be documented in 
information sheets. The topic guide and study tools will be administered by the principal 
researcher herself. Initially, length of time for each interview will be recorded in the pre-
testing phase and an average of time will be settled for consecutive interviews. Common 
ground rules will be established for the discussion on the topic which will be taken in the 
form of notes. The guide will be followed by questions concerning hypertension, its 
management, treatment and self management among hypertensive patients. The study 
tools will be reviewed by subject experts and will be pre-tested for DCP3 based 
hypertension intervention’s acceptance, feasibility and adaptability into the local context 
and will be thus modified based on the findings of the formative phase. Furthermore, 
their awareness, perception, self-rated health and importance of early detection of 
hypertension will also be assessed. The study questionnaires are adapted from RAND 
36‐item health survey 1.0. and Health Belief Model. The qualitative interviews will be 
transcribed into Urdu and will be translated into English language. The interviews will be 
conducted until saturation is achieved, the results will be coded into themes and findings 
will be hence reported.  
 
D. Sample Size: 
Using team-based care model(39), purposive sampling will be opted to select study 
respondents for qualitative interviews in accordance with the sampling matrix as follows: 
 

13 
 
 
  
 
 
 
 
 
 
 
 
Table 4: Sampling Matrix for Qualitative Interviews from Study Respondents (n=55) 
As indicated in the sampling matrix (Table 4), the in-depth interviews will be conducted 
after obtaining consent from the study participants who will be subject experts and 
cardiologists or physicians. Purposive sampling will be used to identify key subject 
experts in the field similarly; the physicians will be asked for their contribution to the 
study. The consent will be taken by the principal investigator herself and they will 
ensured for anonymity and confidentiality to be protected. The contact details of the 
study participants will be obtained from relevant authorities, they will be asked to provide 
a suitable time for the interview. All interviews will be audio recorded as well as notes 
will be taken which will be transcribed and translated into English language. The focus 
group interviews with 6-8 participants will be conducted twice or more until the 
saturation is achieved on the coded themes for the FGDs. However; FGD conducted 
among hypertensive patients will include equal number of male and female patients 
which will be stratified into two age groups i.e. less than 30 years and more than 30 years 
age groups. These FGDs will be conducted at the study site for which a suitable time, day 
and location will be decided. In FGDs, study assistant will accompany the principal 
researcher as facilitator and will ensure time and established rules to be followed in the 
discussion. 
 
 
E. Analysis Technique: 
S. No. 
Study Respondent/s 
Number of 
Participants 
Total 
Interviews 
For IDI 
1. 
Subject Experts 
02 
02 
2. 
Cardiologist / Physicians 
05 
05 
                             For FGD 
3. 
Pharmacists 
6-8 persons 
x2 
4. 
Nurses 
6-8 persons 
x2 
5. 
Patients with uncontrolled hypertension 
stratified in age groups of 30 years and 
30 years above 
6-8 persons 
x4 
Total number of interviews 
15 

14 
 
The interviews will be conducted according to the specified themes which will be coded 
for the purpose of analysis. All interviews will be audio recorded and will be transcribed and 
then translated into English language. Thematic analysis will be conducted to interpret the 
result findings for this study. 
 
F. Development of Intervention: 
Subsequent to above mentioned steps the intervention based on DCP3 strategies will be 
adapted, developed and modified. Following will be main components of the intervention 
development: 
 
a. Content of Intervention: 
The content of intervention will base on the findings of desk review and 
qualitative interviews. The behavioural intervention will be largely patient-focused 
which will adhere to aspects of self-management by the patient, compliance to 
treatment, involvement of family members in reducing the BP of the patient so as to 
facilitate changes in diet and life style pattern. The characteristics of the participants 
will be kept in consideration and preferred language as identified in the interviews 
will be used to develop the training materials to educate hypertensive patients on it. 
As the intervention based on DCP3 strategies will be deployed to 220 hypertensive 
patients with 110 patients in intervention and control arm. Minimum two physicians / 
resident medical officer (RMOs) will be trained by the principal investigator on 
delivering the intervention among patients recruited in the intervention arm. The 
physicians will be required to provide an allocated time as identified by the findings of 
qualitative interviews to counsel the patients on DCP3 defined strategies to reduce BP 
to the recommended target. Monitoring and supervision of the procedure and 
collection of data will be done by the principal investigator along with a study 
assistant. 
 
b. Feedback by Study Respondents: 
After completion of data collection, a feedback will be obtained from all study 
participants of the formative phase particularly the physicians who will deliver the 

15 
 
intervention. Following the formative phase, an evaluative research on effectiveness 
of intervention based on DCP3 strategies will be conducted using a randomized 
controlled study design (Phase II) which will adhere to CONSORT guidelines.  
 
7. Proposed Methodology 
The following research methodology will be used to conduct this study: 
 
 
7.1. Study Design 
A randomized controlled trial (RCT) study design will be employed (Figure 1) at single study 
setting. The study will be registered at clinicaltrial.gov. Unit of randomization will be the patient 
and the randomization will be achieved by blinding the subjects. 
 
7.2. Study Area 
This study will be conducted at Armed Forces Institute of Cardiology & National Institute of 
Heart Diseases (AFIC/NIHD), Rawalpindi. It is a 250 bedded major tertiary cardiac care center 
in Pakistan established in 1953.(40) The researcher will conduct the field work and will visit the 
study site for data collection after enrolling patients in the trial. 
 
7.3. Duration of Study 
The formative phase this study will be initiated in October 2019 and will complete by 
November 2019. Enrollment of patients will start from November 2019 and simultaneously the 
pre-testing will be conducted. The trial will be of three months from baseline data collection to 
the follow up of patients from November 2019 till January 2019. Patients will be enrolled after 
obtaining their verbal and written consent for participation. 
 
7.4. Data Sources 
The formative phase of the study will employ purposive sampling technique which will involve 
subject experts and physicians to assess the current practices for managing and treating 

16 
 
hypertension. It will also facilitate the adaptation of DCP3 interventions in the local context for 
primary prevention of cardiovascular diseases. The findings of formative research will help to 
modify the intervention, its convenience and mode of delivery. The formative survey will assess 
the current practices for managing and treating hypertension. The study participants will be 
interviewed using a face to face interview approach and participating patients will be observed 
for the blood pressure measurements.  
 
7.5. Study Population 
For the formative phase, the study population will consists of subject experts, physicians and the 
hypertensive patients at the study setting. For the intervention phase, hypertensive patients will 
be screened and recruited into the trial on the basis of pre-defined criteria and the intervention 
will administered to the patients randomized in the intervention arm. Whereas; patients in the 
control arm will receive the routine medical care for hypertension. Patients receiving the 
intervention will required for weekly follow-up and patients in the control arm will be required 
to follow every two week at the study setting for blood pressure evaluation. 

17 
 
 
Figure 2: Overview of Study Design 
7.5.1. Randomization 
For the formative phase, purposive sampling technique will be employed and face to face 
interviews of subject experts and physicians will be conducted. Similarly, 15% of the patients 
will be selected using a convenience-based sampling technique. The IDI study tools will be pre-
tested for the DCP3 intervention’s acceptance, feasibility and adaptability into the local context 
and will be thus modified based on the findings of the formative phase. Furthermore, their 
awareness, perception, self-rated health and importance of early detection of hypertension will 
also be assessed. The IDI study questionnaire will be adapted from RAND 36‐item health survey 
1.0. and the Health Belief Model. Whereas; for the intervention phase, study tools will be 
developed and modified on the preference of patients as indicated in the formative research. 
Study questionnaires will be pre-tested on 15% of patients and then the baseline data will be 

18 
 
collected. All the data will be collected after obtaining an ethical approval from the institutional 
review board of Health Services Academy and AFIC/NIHD hospital. The data will be kept 
confidential and will be maintained in the personal computer of the principal investigator which 
will not be shared in or outside the study setting except with the co-researchers.  
 
First 200 hypertensive patients meeting the eligibility criteria and having systolic blood pressure 
of  ≥140 mmHg in the absence of target organ damage, either on current treatment or been newly 
diagnosed with hypertension will be invited to participate in the study (Figure 1). After obtaining 
their written and verbal consent, systolic and diastolic blood pressure of recruited patients will be 
measured and patients will be assessed for medical history, current therapy, lipids and glucose 
level in the blood. Using random number technique, randomization will be achieved by selecting 
every 9th patient at the out-patient department (OPD) of AFIC/NIHD. Patients will be informed 
about the study purpose and their consent will be obtained for participation. They will be referred 
to the consulting physician/medical officer/RMO for their routine medical care/physical 
examination and ECG (if advised). The blood pressure and weight measurements will be 
assessed at each visit. The laboratory parameters involving routine blood investigations 
prescribed by the physician such as fasting glucose (RBS and HbA1c), lipids, cholesterol, urea, 
critinine, calcium will be assessed at the baseline and endline of the trial. Following the routine 
medical care, patients in the intervention arm will be provided counseling on diet and physical 
exercise. The key messages will be formulated on the basis of available evidence, literature 
review and formative research findings. Whereas; timing of each session, provision of 
awareness/counseling and mode of administering the intervention on DCP3 components will be 
determined on the preference of patients as specified in the IDIs. 
 
A study assistant / observer independent of the study will assign randomly selected 100 patients 
into each arm. The patients will be registered into the study with the randomization ID number or 
CNIC number. Baseline characteristics of all study participants will be recorded. The height of 
the patient will be measured using stadiometer by a wall and the weight will be measured using a 
weighing machine for the body mass index (BMI). The patient will be asked to sit in a relaxed 
position and after 5-10 minutes, the patient will be asked to put left arm at 45 degrees for BP 
check-up. Using the brachial artery, readings of BP will be taken thrice and an average of three 

19 
 
readings will be recorded. Patients will also be instructed to report any adverse event and will 
also be provided the contact information of the resident physician/principal investigator in case 
of emergency. In case of withdrawal from the study, patients will have no liability. Including 
10% non-response rate, the total number of study participants included will be 220. To reduce 
contamination, data will be collected at a point distant to physician’s room. 
 
7.5.1.1. Intervention Arm 
Patients in the intervention arm will receive a combination therapy for the management of 
hypertension for primary prevention of cardiovascular diseases & CHD risk reduction based on 
DCP3 recommended strategies (Table 1). Pharmacotherapy will be provided by the physician and 
the intervention comprising of DCP3 interventions will be administered by the principal 
investigator. To control BP to the recommended target, at least two hypertensive agents will be 
required in the treatment regimen according to the hypertension guidelines.(5) Furthermore, 
patients will be assessed for compliance to medications, follow up and subsequent counseling 
will be provided for lifestyle modification, stress management and changes in diet such as 
consuming vegetables and a low fat food.(5) At each appointment, patient will be evaluated for 
adherence to the aforementioned strategies and therapeutic regimen. The ultimate aim of the 
intervention will be to reduce the blood pressure and to improve patient’s risk factors within 
recommended goals. Figure 1 provides an overview of the combination therapy based on DCP3 
strategies. 

20 
 
 
Figure 3: Overview of a Four Component Hypertension Control Intervention based on 
DCP3 Strategies(5) 
7.5.1.2. Control Arm 
Patients assigned to the control arm will be expected to receive routine medical care involving 
pharmacotherapy prescribed by the physician. Patients will be screened for SBP, DBP, lipids, 
diabetes and smoking. Regular monitoring of patients in improvement seeking care and 
adherence to medication will be assessed. Patients will be asked for follow up after every two 
weeks for BP measurements. They will be given awareness about hypertension only at the initial 
point of recruitment into the study. 
 
7.6. Sampling Technique 
7.1. Participants’ Selection & Recruitment Procedure 
Patients will be enrolled using a convenience-based sampling technique. Study participants 
will be registered during the study duration. Every 9th patient will be assigned to either 
intervention or control arm in a 1:1 ratio. The study will be carried out in accordance with 
CONSORT guidelines.(41) Each patient will serve as a unit of randomization in this study. All 
Pharmacotherapy
Screening for 
i. SBP
iii. Diabetes
ii. BMI
iv. Lipids
v. Smoking
Compliance to 
Treatment/
Medication
Counseling
i. Smoking Cessation
ii. Lifestyle 
Modifications
iii. Changes in diet

21 
 
data will be collected after obtaining their consent (both written and verbal). They will be 
enrolled after explaining them the purpose of the study. The provided information will be kept 
strictly confidential and their privacy will be protected. 
 
7.2. Sample Size Calculation 
First 200 hypertensive patients will be selected through convenience-based sampling technique. 
The sample size was calculated using a two-tailed alpha level of p=0.05 and power of 0.80 
including a non-response rate of 10%, the total sample size calculated was 220 hypertensive 
patients. Each 110 of patients will be assigned to either intervention arm or control arm into 1:1 
ratio.  
 
 7.2.1. Sample Recruitment:  
7.2.1.1. Inclusion Criteria 
 Pakistani nationals both male and female of age 18 years and above will be invited to 
participate in the study  
 Similarly; known hypertensive patients having systolic blood pressure of ≥140 mmHg 
on current treatment will be included & 
 Patients with co-morbidities will also be included such as those suffering from 
cardiac ailments (angina or transient ischemic attack (TIA) and diabetes  
 
7.2.1.2. Exclusion Criteria 
 Patients with compromised neurological or cognitive state who are unable to provide 
their consent will be excluded 
 Patients suffering from non-cardiovascular diseases and life-threatening illnesses such 
as angiographically proven coronary disease, peripheral or cerebral vascular disease, 
pulmonary hypertension, having history of myocardial infarction, stroke/PCI/stent or 
high-risk conditions will be excluded from participation 
 Patients with chronic conditions and co-morbidities requiring surgical intervention or 
treatment such as cardiomyopathies or congenital abnormalities & 

22 
 
 Patients receiving dialysis will also be excluded from the study 
 
7.3. Data Collection Techniques 
The data collection will be initiated after obtaining an ethical approval from Health Services 
Academy (HSA). Open-ended and structured study instruments will be used to collect data for 
the formative phase (Appendices) which will be adapted from RAND 36‐item health survey 1.0. 
and the Health Belief Model.(42,43) It will be covering the constructs as shown in Figure 3. 
Initially, it will be drafted in English and will be translated into the local language Urdu and will 
be then back translated in English language. The study instruments will be pre-tested on the same 
study population. Purposive sampling technique will be used to collect data from study 
participants of the formative phase which will include subject experts, physicians and 
hypertensive patients at the study site. In-depth interviews with the study participants will be 
conducted by the principal investigator which will last for 40-60 minutes. All interviews will be 
recorded in a rechargeable audio stick / audio recorder. The collected data will be then 
transcribed and translated for the purpose of analysis. The questionnaire will be self-
administered to the subject experts and physicians while patients will be asked to answer the 
questions. They will be ensure for comfort and confidentiality. A written and verbal consent for 
participation will be obtained from all the study participants before the data collection.s 
 
Figure 4: Health Belief Model (Jones, 2015) 

23 
 
For the intervention phase, the study instrument will be adapted based on DCP3 strategies 
(Figure 1). The intervention will encompass counseling on the components of DCP3 strategies as 
mentioned in Table 1. The study instrument will be pre-tested and will be then modified 
accordingly. It will be drafted in English and the principal investigator will record and maintain 
the database, periodically. Each patient will serve as the unit of randomization and will be 
systematically assigned to either intervention or control arm of the trial. The principal 
investigator will collect weekly data from the patients in the intervention arm at the baseline and 
subsequently at second and third months of delivering the intervention. All researchers involved 
in this study will assure for the completeness and accuracy of the data collected. 
 
7.4. Procedures for Data Collection and Study Measures 
The following will be the method of assessments: 
 
7.4.1. Blood Pressure & Physical Measurements 
Five blood pressure readings will be taken of which average will be recorded in the information 
sheets in the first visit of the patient. The patient will be asked to be seated for 5-10 minutes prior 
to the assessment using manual sphygmomanometer and in accordance to American Heart 
Association guidelines.(44) The same procedure will be followed at every visit of patients in 
intervention and control arm both. Height will be measured using stadiometer /tape rule and 
weight will be measured using a weighing machine to calculate the body mass index (BMI). 
 
7.4.2. Cardiovascular Risk Scoring 
The CV risk score will be evaluated through scoring the indicators of CV risk using American 
College of Cardiology/American Heart Association ACC/AHA guildelines 2013.(45) It will 
include laboratory parameters such as fasting blood glucose (FBS), lipid profile, cholesterol and 
calcium levels. 
 
7.4.3. Patient’s Socio-demographics 
Socio-demographic data of patients will be collected on selected variables such as age, marital 
status, educational level, employment status, occupation and total household income. Also, it 

24 
 
will include medical history health insurance coverage, number and cost of medicines, year of 
diagnosis of hypertension, previous medical history, and adherence to medication(46) will be 
assessed. Consumption of specified food and restriction on salt intake will be monitored as well 
as daily physical activity(47,48) will be recorded.  
 
7.5. Data Collection Tool 
Study instrument of the formative phase administered to the subject experts and physicians 
will assess current hypertension guideline being practiced for the treatment and management of 
hypertension control. Study instrument for hypertensive patients will assess patient’s knowledge 
regarding hypertension, perception about structured care being received, life style practices, 
follow-up pattern and compliance to treatment. Socio-demographic characteristics of the 
patients, information on physical activity and diet pattern will be assessed. The study tools will 
be will be pre-tested and validated. Expert review on study instruments will be obtained and 
these will be modified accordingly (Appendices). The study tools will be drafted in English, 
translated into local language Urdu and will be then back translated into English language. 
 
7.5.1. Pre-testing 
Study instruments will be pretested on 15% of the patients. For formative phase, the study 
instrument will be administered to subject experts and physicians sampled through purposive 
sampling technique.  
 
7.6. Issues of reliability and validity 
Concurrent validity will be calculated by administering the study instrument to subject 
experts, physicians and 15% of hypertensive patients. For the IDIs, construct validity will be 
opted to ensure generalizability. Study instrument of the intervention phase will be validated 
using face validity and it will be then modified after expert review. Whereas, Test-Retest Method 
will be used to ensure reliability of the study instruments. 
 
 

25 
 
7.7. Data Analysis Plan 
The average of blood pressure measurements will be taken for each of the study participant at the 
baseline and follow-up visits. Repeated ANOVA measure will applied to calculate the changes in 
mean scores of BP measurements at baseline, second and third month of trial. Paired t-test will 
be used to test the significance between the baseline and follow-up blood pressure measurements 
within each study arm. Chi-square test will be used to analyze the difference in blood pressure 
control rate between the intervention and control arm and with other co-variates. A p-value of ≤ 
0.05 will be considered as significant. Predictors of blood pressure control at the patient level 
will be identified at the follow up where covariates will be included in the analysis. Whereas; the 
effect size will be reported in odds ration with 95% CI. Data will be double entered for the 
purpose of cleaning and will be analyzed using SPSS version 21.  
 
7.7.1. OUTCOME MEASURES 
7.7.1.1. Primary Endpoint 
The primary endpoint of the study will be control and reduction in systolic blood pressure 
below recommended target of 140/90 mm Hg from baseline to 03 months after intervention. 
Adequate BP control will be assessed by taking BP measurement and BMI of the patients in the 
intervention arm and it will be compared with the control arm. 
 
7.7.1.2. Secondary Endpoint 
The secondary endpoint will be to determine proportion of patients with adequate BP control 
at 03 months. Secondary outcomes for BP reduction will be assessed through use of number of 
antihypertensive drugs, compliance to treatment, self-rated health before and after the 
intervention. Moreover, cardiovascular risk score will also be calculated. 
 
7.8. Ethical Considerations 
Ethical approval will be obtained from the Institutional Review Board (IRB) of Health 
Services Academy (HSA) and Armed Forces Institute of Cardiology/National Institute of Heart 
Diseases (AFIC/NIHD), Rawalpindi. After obtaining an ethical approval, the study will be 

26 
 
carried out as per the institutional and ethical guidelines for research studies involving human 
subjects.(49) The data will be collected after obtaining an informed consent (both verbal and 
written) from each of the study participant. All participants will be enrolled after explaining them 
the purpose of the study. Their provided information will be kept strictly confidential and their 
privacy will be protected. 
 
8. & 9.Timeline and Budget 
 
 
 
Figure 5: Study Phases from Baseline to Follow Up
PHASE 1
FORMATIVE STUDY
Basline information gathering after 
recruiting participants thorugh IDIs
PHASE 2
Developing & testing of intervention.
Baseline measurement & follow up after 
one month of delivering intervention
PHASE 3
Evaluation & Follow up at 3 months 
post-intervention

 
 
References 
1.  
WHO | Hypertension. WHO [Internet]. 2017 [cited 2018 Dec 30]; Available from: 
https://www.who.int/topics/hypertension/en/ 
2.  
Murray CJL, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C, et al. Disability-
adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010: a 
systematic analysis for the Global Burden of Disease Study 2010. Lancet [Internet]. 2012 
Dec 15 [cited 2018 Dec 31];380(9859):2197–223. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/23245608 
3.  
Batool A, Gilani P, Javed T. Risk factors, pathophysiology and management of 
hypertension. Int J Pharma Sci Sci Res [Internet]. 2018 [cited 2019 Feb 11];4(5):49–61. 
Available from: https://biocoreopen.org/ijpsr/Risk-factors-pathophysiology-and-
management-of-hypertension.pdf 
4.  
Yusuf S, Rangarajan S, Teo K, Islam S, Li W, Liu L, et al. Cardiovascular Risk and 
Events in 17 Low-, Middle-, and High-Income Countries. N Engl J Med [Internet]. 2014 
Aug 28 [cited 2018 Dec 31];371(9):818–27. Available from: 
http://www.nejm.org/doi/10.1056/NEJMoa1311890 
5.  
Jeemon P, Gupta R, Onen C, Adler A, Gaziano TA, Prabhakaran D, et al. Management of 
Hypertension and Dyslipidemia for Primary Prevention of Cardiovascular Disease 
[Internet]. [cited 2018 Dec 31]. Available from: http://dcp-
3.org/sites/default/files/chapters/DCP3 CVRD_Ch 22.pdf 
6.  
WHO | A global brief on hypertension. WHO [Internet]. 2013 [cited 2018 Dec 31]; 
Available from: 
https://www.who.int/cardiovascular_diseases/publications/global_brief_hypertension/en/ 
7.  
Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, et al. A comparative 
risk assessment of burden of disease and injury attributable to 67 risk factors and risk 
factor clusters in 21 regions, 1990–2010: a systematic analysis for the Global Burden of 
Disease Study 2010. Lancet [Internet]. 2012 Dec 15 [cited 2018 Dec 31];380(9859):2224–
60. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23245609 
8.  
GBD 2015 Eastern Mediterranean Region Cardiovascular Disease Collaborators G 2015 
EMRCD. Burden of cardiovascular diseases in the Eastern Mediterranean Region, 1990-
2015: findings from the Global Burden of Disease 2015 study. Int J Public Health 
[Internet]. 2018 May [cited 2019 Jan 8];63(Suppl 1):137–49. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/28776245 
9.  
Horton S, Gelband H, Jamison D, Levin C, Nugent R, Watkins D. Ranking 93 health 
interventions for low- and middle-income countries by cost-effectiveness. 2017 [cited 
2019 Feb 12]; Available from: https://doi.org/10.1371/journal.pone.0182951 
10.  
WHO | Raised blood pressure. WHO [Internet]. 2016 [cited 2019 Jan 11]; Available from: 
https://www.who.int/gho/ncd/risk_factors/blood_pressure_text/en/ 
11.  
Shah N, Shah Q, Shah AJ. The burden and high prevalence of hypertension in Pakistani 
adolescents: a meta-analysis of the published studies. [cited 2019 Jan 11]; Available from: 
https://doi.org/10.1186/s13690-018-0265-5 
12.  
WHO | Raised blood pressure. WHO [Internet]. 2015 [cited 2019 Jan 11]; Available from: 

2 
 
https://www.who.int/gho/ncd/risk_factors/blood_pressure_prevalence_text/en/ 
13.  
Singh S, Shankar R, Singh GP. Prevalence and Associated Risk Factors of Hypertension: 
A Cross-Sectional Study in Urban Varanasi. Int J Hypertens [Internet]. 2017 [cited 2019 
Jul 27];2017:5491838. Available from: http://www.ncbi.nlm.nih.gov/pubmed/29348933 
14.  
EVERETT B, ZAJACOVA A. Gender Differences in Hypertension and Hypertension 
Awareness Among Young Adults. Biodemography Soc Biol [Internet]. 2015 [cited 2019 
Jul 27];61(1):1. Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4896734/ 
15.  
Ragot S, Beneteau M, Guillou-Bonnici F, Herpin D. Prevalence and management of 
hypertensive patients in clinical practice: Cross-sectional registry in five countries outside 
the European Union. Blood Press [Internet]. 2016 Mar 3 [cited 2019 Jul 31];25(2):104–16. 
Available from: http://www.ncbi.nlm.nih.gov/pubmed/26873621 
16.  
Mahmood S, Shah KU, Khan TM, Nawaz S, Rashid H, Baqar SWA, et al. Non-
pharmacological management of hypertension: in the light of current research. Irish J Med 
Sci (1971 -) [Internet]. 2019 May 22 [cited 2019 Jul 31];188(2):437–52. Available from: 
http://link.springer.com/10.1007/s11845-018-1889-8 
17.  
Bazzano LA, Green T, Harrison TN, Reynolds K. Dietary approaches to prevent 
hypertension. Curr Hypertens Rep [Internet]. 2013 Dec [cited 2018 Dec 30];15(6):694–
702. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24091874 
18.  
Brokmann JC, Rossaint R, Müller M, Fitzner C, Villa L, Beckers SK, et al. Blood pressure 
management and guideline adherence in hypertensive emergencies and urgencies: A 
comparison between telemedically supported and conventional out-of-hospital care. J Clin 
Hypertens [Internet]. 2017 Jul [cited 2019 Jul 31];19(7):704–12. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/28560799 
19.  
Siddiqui M, Islam MY ul, Mufti BAI, Khan N, Farooq MS, Muhammad MG, et al. 
Assessing acceptability of hypertensive/diabetic patients towards mobile health based 
behavioral interventions in Pakistan: A pilot study. Int J Med Inform [Internet]. 2015 Nov 
1 [cited 2019 Jul 31];84(11):950–5. Available from: 
https://www.sciencedirect.com/science/article/abs/pii/S1386505615300332?via%3Dihub 
20.  
Tazeen Jafar. AKU Launches Largest Study on Hypertension in Pakistan | The Aga Khan 
University News [Internet]. [cited 2019 Jul 28]. Available from: 
https://clinicaltrials.gov/ct2/show/record/NCT00327574 
21.  
WHO EMRO | High blood pressure: a public health problem | World Health Day 2013 | 
World Health Days [Internet]. [cited 2019 Jan 8]. Available from: 
http://www.emro.who.int/media/world-health-day/public-health-problem-factsheet-
2013.html 
22.  
Kjeldsen SE, Aksnes TA, Fagard RH, Mancia G. Hypertension. In: The ESC Textbook of 
Cardiovascular Medicine [Internet]. Oxford University Press; 2009 [cited 2019 Jul 19]. p. 
437–63. Available from: 
http://oxfordmedicine.com/view/10.1093/med/9780199566990.001.0001/med-
9780199566990-chapter-13 
23.  
GHO | By category | Risk of premature death from the four target NCDs - Data by WHO 
Region. WHO [Internet]. [cited 2019 Jan 11]; Available from: 
http://apps.who.int/gho/data/view.main.2485REG?lang=en 
24.  
Afshin A, Micha R, Webb M, Capewell S, Whitsel L, Rubinstein A, et al. Effectiveness of 
Dietary Policies to Reduce Noncommunicable Diseases [Internet]. [cited 2019 Jan 11]. 

3 
 
Available from: http://dcp-3.org/sites/default/files/chapters/DCP3 CVRD_Ch 6.pdf 
25.  
About the Project | DCP3 [Internet]. [cited 2019 Jul 28]. Available from: http://dcp-
3.org/about-project 
26.  
GHO | By category | Risk of premature death from the four target NCDs - Data by MDG 
Region. WHO [Internet]. [cited 2019 Jan 11]; Available from: 
http://apps.who.int/gho/data/view.main.2485MDG?lang=en 
27.  
Pakistan Risk of Prematre Death to NCDs (%)*. [cited 2019 Jan 12]; Available from: 
https://www.who.int/nmh/countries/2018/pak_en.pdf?ua=1 
28.  
Best Buys. Tackling NCDs [Internet]. 2009 [cited 2019 Jan 12]. Available from: 
http://apps.who.int/iris/bitstream/handle/10665/259232/WHO-NMH-NVI-17.9-
eng.pdf?sequence=1 
29.  
World Health Organization. Men’s health checklist [Internet]. [cited 2019 Jan 12]. 
Available from: https://www.who.int/news-room/feature-stories/detail/men’s-health-
checklist 
30.  
DASH Eating Plan | National Heart, Lung, and Blood Institute (NHLBI) [Internet]. [cited 
2018 Dec 30]. Available from: https://www.nhlbi.nih.gov/health-topics/dash-eating-plan 
31.  
Ishtiaq S, Ilyas U, Naz S, Altaf R, Afzaal H, Muhammad SA, et al. Assessment of the risk 
factors of hypertension among adult &amp; elderly group in twin cities of Pakistan 
[Internet]. Vol. 67. 2017 [cited 2019 Jul 27]. Available from: 
https://jpma.org.pk/PdfDownload/8428 
32.  
HEALTH SITUATION [Internet]. 2018 [cited 2019 Jul 20]. Available from: 
http://apps.who.int/gho/data/node.cco 
33.  
Saleem F, Dua JS, Hassali AA, Shafie AA. Hypertension in Pakistan: time to take some 
serious action. Br J Gen Pract [Internet]. 2010 Jun [cited 2019 Jul 27];60(575):449–50. 
Available from: http://www.ncbi.nlm.nih.gov/pubmed/20529498 
34.  
Lippincott Williams & Wilkins. 2003 World Health Organization (WHO)/International 
Society of Hypertension (ISH) statement on management of hypertension. [cited 2019 Jan 
11]; Available from: 
https://www.who.int/cardiovascular_diseases/guidelines/hypertension_guidelines.pdf?ua=
1 
35.  
WHO | WHO/ISH Hypertension guidelines. WHO [Internet]. 2013 [cited 2019 Jan 11]; 
Available from: https://www.who.int/cardiovascular_diseases/guidelines/hypertension/en/ 
36.  
2019 ICD-10-CM Diagnosis Code I10: Essential (primary) hypertension [Internet]. [cited 
2019 Jan 12]. Available from: https://www.icd10data.com/ICD10CM/Codes/I00-I99/I10-
I16/I10-/I10 
37.  
Ogedegbe G, Plange-Rhule J, Gyamfi J, Chaplin W, Ntim M, Apusiga K, et al. A cluster-
randomized trial of task shifting and blood pressure control in Ghana: study protocol 
[Internet]. 2014 [cited 2019 Jul 19]. Available from: 
http://www.implementationscience.com/content/9/1/73 
38.  
Control High Blood Pressure | 6|18 Initiative | CDC [Internet]. [cited 2019 Oct 18]. 
Available from: https://www.cdc.gov/sixeighteen/bloodpressure/index.htm 
39.  
Community Preventive Services Task Force T. Cardiovascular Disease Prevention: Team-
Based Care to Improve Blood Pressure Control Task Force Finding and Rationale 
Statement.  
40.  
AFIC / NIHD [Internet]. [cited 2019 Jul 14]. Available from: 
http://afic.gov.pk/?page_id=126 

4 
 
41.  
Consort - Welcome to the CONSORT Website [Internet]. [cited 2019 Jul 15]. Available 
from: http://www.consort-statement.org/ 
42.  
Jones CL, Jensen JD, Scherr CL, Brown NR, Christy K, Weaver J. The Health Belief 
Model as an explanatory framework in communication research: exploring parallel, serial, 
and moderated mediation. Health Commun [Internet]. 2015 [cited 2019 Sep 
15];30(6):566–76. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25010519 
43.  
RAND. The RAND 36-Item Health Survey The RAND 36-Item Health Survey. Heal (San 
Fr. 1992;2(March):91–7.  
44.  
2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline 
for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in 
Adults - Health Metrics [Internet]. [cited 2019 Jul 15]. Available from: 
https://healthmetrics.heart.org/2017-guideline-for-the-prevention-detection-evaluation-
and-management-of-high-blood-pressure-in-adults/ 
45.  
Lloyd-Jones DM, Bennett G, Coady S, D RB, Gibbons R, Greenland P, et al. 2013 
ACC/AHA Guideline on the Assessment of Cardiovascular Risk. S49 (Circulation 
[Internet]. 2014 [cited 2019 Jul 27];129:49–73. Available from: 
http://circ.ahajournals.org/lookup/suppl/doi:10.1161/01.cir.0000437741.48606.98/-/DC1. 
46.  
Plank T. 41 to improve hypertension control [Internet]. [cited 2019 Jul 17]. Available 
from: http://www.measureuppressuredown.com/HCProf/Find/Toolkit/Plank4Tool1.pdf 
47.  
WHO Global Recommendations on Physical Activity for Health [Internet]. 2010 [cited 
2019 Jul 17]. Available from: https://www.who.int/dietphysicalactivity/global-PA-recs-
2010.pdf 
48.  
Global Physical Activity Questionnaire (GPAQ) WHO STEPwise approach to NCD risk 
factor surveillance Surveillance and Population-Based Prevention Prevention of 
Noncommunicable Diseases Department World Health Organization [Internet]. [cited 
2019 Jul 17]. Available from: www.who.int/chp/steps 
49.  
International Ethical Guidelines for Health-related Research Involving Humans Prepared 
by the Council for International Organizations of Medical Sciences (CIOMS) in 
collaboration with the World Health Organization (WHO). 2016 [cited 2018 Apr 9]; 
Available from: https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-
EthicalGuidelines.pdf 

 
 
10. Appendix 
Appendice A. Informed Consent for Participation into the Research Study 
 
 
 
[YOUR INSTITUTIONAL LETTER HEAD] 
 
[Informed Consent Form for participation in formative study (Phase 1)] 
This informed consent form is for cardiologists, subject experts, nurses and patients.  
 
[Name of Principle Investigator] 
Subhana Akber, PhD Fellow 2017 
[Name of Organization]  
 
Health Services Academy, Islamabad Pakistan 
[Name of Project]  
Implementation of DCP3 Strategies to Manage and Control 
Hypertension among Hypertensive Patients in Pakistan: A 
Randomized Controlled Trial 
 
Part I: Information Sheet 
Introduction  
 
I am Subhana Akber, doctoral student at HSA, Islamabad. I am conducting a research on 
hypertensive patients which comprises of an intervention on reducing blood pressure. The study 
duration is of 03 months. Hence, I would like to invite you for participation in this study. I shall 
be having your interview which will require less than 10 minutes of your time. Your participation 
is entirely voluntary. Read the information below, and please feel free to ask any question before 
participation. 
 
Purpose of the research  
Hypertension is a substantial public health concern and among major causes of deaths all over the 
world. It is a disease which is been termed as a “silent killer” that tends to cause premature 
Informed Consent Form 

2 
. 
 
mortality. Incidence of hypertension is escalating in Pakistan with an estimated 18.9 - 29.2% of 
Pakistani adults are reported to be hypertensive. It is however; essential for hypertension 
management and control that early screening may be done along with initiation of hypertension 
treatment and management to reduce incidence of cardiovascular diseases. Therefore, we want to 
learn about the current practices of physicians and awareness among patients about hypertension.   
 
Type of Research Intervention 
The study is a randomized controlled trial which involves non-invasive blood pressure 
measurements. Moreover, IDI interviews are a component of qualitative research. Your answers 
will help to contribute to the formative phase of our study and in the deployment of intervention 
to hypertensive patients. This will require less than 10 minutes of your valuable time. 
 
Participant Selection  
You have been randomly selected and invited to participate in this study on the basis of your 
experience and knowledge. If case, if you are a patient, we would like to know about your 
understanding on this public health priority. 
 
Voluntary Participation  
Your participation in this research is entirely voluntary. It is your choice whether to participate or 
not. However; you can withdraw only in case you report serious adverse events during the study 
period. 
 
Procedures  
After obtaining your verbal and signed consent form, you will be required to answer a few set of 
questions that will assess your knowledge about hypertension. Whereas; participation into the 
trial will require you to visit the health facility where twice a weekly your blood pressure will be 
measured and record will be kept. All information will be kept save in the personal computer of 
the principal investigator.  
 
 
 

3 
 
Duration 
The research will take place for a period of four months. Recruited patients will be required to 
visit the health facility twice a month for measuring their BP readings and baseline 
characteristics.  
 
Risks  
Since, the study bears no clinical procedure or clinical testing of medicine. However; still you 
will be provided contact information of physician in case of emergency. 
 
Benefits  
There will be no direct benefit to you, but your participation is likely to help us find out more 
about how to manage and control high bold pressure among hypertensive patients. 
 
Reimbursements 
You will not be provided any incentive to take part in the research or for your time, and travel 
expenses. 
 
Confidentiality  
It is to assure that all your information will be kept highly confidential and in strict privacy. No 
data will shared with anyone except with the co-investigators. 
 
Sharing the Results  
Nothing that you tell us today will be shared with anybody outside the research team, and nothing 
will be attributed to you by name. The knowledge that we get from this research will be shared 
with you (upon request) before it is made widely available to the public. Each participant will 
receive a summary of the results. Small meetings will be held at hospitals to ensure that the gap of 
knowledge is fulfilled by the results of this research. 
 
Right to Refuse or Withdraw  
This is a reconfirmation that participation is voluntary and includes the right to withdraw. 
Participants will have an opportunity to review their remarks in individual interviews. 

4 
. 
 
 
Who to Contact 
If you have any questions, you can ask them now or later. If you wish to ask questions later, you 
may contact any of the following: [Subhana Akber, Contact No. 0312-8661755, email: 
subhanaakber@gmail.com. This proposal has been reviewed and approved by IRB of Health 
Services Academy which is a committee whose task it is to make sure that research participants 
are protected from harm. 
 
Part II: Certificate of Consent 
 
I have read the foregoing information, or it has been read to me. I have had the opportunity to ask 
questions about it and any questions I have been asked have been answered to my satisfaction. I 
consent voluntarily to be a participant in this study. My participation is entirely voluntary in this 
research and I agree to the terms of research and the principal investigator. 
 
 
Name of Participant/Thumb Impression 
__________________  
  
 
 
 
Signature of Participant  
 
 
__________________ 
 
Date ___________________________ 
 
Day/month/year 
 
  
 
 
Thumb print of participant  
 
 
 
 

5 
 
Statement by the Researcher/Person Taking Consent 
 
I have accurately read out the information sheet to the potential participant, and to the best of 
my ability made sure that the participant understands that the following will be done: 
 
1. 
It is a non-invasive study that bears no clinical testing except measuring the blood pressure 
of the patients. 
2. 
The participation of the patient is entirely voluntary and bears no benefit, risk or harm. 
3. 
Participating patient has been provided the complete contact information of the physician 
and principal investigator in terms of emergency or adverse event. 
 
I confirm that the participant was given an opportunity to ask questions about the study, and all 
the questions asked by the participant have been answered correctly and to the best of my ability. 
I confirm that the individual has not been coerced into giving consent, and the consent has been 
given freely and voluntarily. 
 
A copy of this ICF has been provided to the participant. 
 
Name of Researcher/person taking the consent:  
Subhana Akber 
 
 
 
 
Signature of Researcher /person taking the consent:    ________________________ 
Date ___________________________ 
 
 
 
                 Day/month/year 
 
 

6 
. 
 
Appendice B: IDI: PATIENTS 
Ground Rules  
 The interviewer and the note taker shall turn off their cell phones 
 Remain as neutral or impartial as possible  
 Use probes and clarifying questions where required 
 Avoid asking leading questions 
 Ensure all sections are covered 
 
Introduction: 
Asalam-o-Alaikum.Mr/Ms: ____________________s/d/w/o__________________ 
 
I am Subhana Akber, PhD Scholar at Health Services Academy, Islamabad. My 
purpose to meet you today is for an in-depth interview regarding hypertension 
management and control. I thank you for providing me your valuable time to talk on the 
topic. You are requested to provide us your detailed information and your relevant 
experiences with the health care services in the hospital. I would like to know about your 
knowledge regarding hypertension and your health seeking behavior to manage it. I 
assure that your all information will be kept confidential and anonymous. Your interview 
and answers to the questions asked for this interview will be recorded after obtaining 
your consent. I thank you for your contribution to this study and for taking out few 
minutes from you precious time. Please provide your signed consent below: 
 
Time for discussion: One hour 
 
Interviewer’s 
Name & 
Signature: 
  
Affiliation: 
 
 
 
  
  
Email & Contact: 
  
Study participant’s signature for consent: 
Day & Date:  
 
 

7 
 
I. 
PATIENTS’S PROFILE 
Socio-Demographic History of the Patient: 
Name: 
  
s/d/w 
  
Age: 
  
Gender: 
  
Marital Status: 
  
Ethnicity: 
  
Number of Children: 
  
Family Type: 
  
Current Diagnosis: 
  
Duration (years): 
  
Address: 
  
  
  
Contact No. 
  
  
Highest Educational 
Level: 
  
Total Household 
Income (monthly): 
  
Occupation: 
  
Occupation Type: 
  
Regular Medical 
Care: 
Yes      No  
Provider: 
  
Any health insurance 
Yes      No  
Height: 
 Weight: 
Cardiovascular risk factors: 
Smoking Status: 
Yes      No  
 BMI: 
Duration (Years): 
  
 Diabetes: 
Yes      No  
Other co-
morbidities: 
  
 Since Years: 
Duration (Years): 
  
Medical Prescription 
Advised by: 
 
Cost of Medicines 
Purchased (in 
PKR): 
  
Name of Medicines: 
  
  
  
Recommendation: 
 
Next follow-up: 
 

8 
. 
 
II. INTERVIEW 
1. In general, would you say your health is [Self-rated health]: (Circle One) 
 
i. 
Excellent ………………….1 
ii. 
Very good…………………2 
iii. 
Good………………………3 
iv. 
Fair…………………….…..4 
v. 
Poor………………………..5 
 
2. Have you ever been part of any hypertension control program? If please share the details. 
3. In your opinion, what is hypertension? 
4. How early detection of hypertension is important? (Circle One) 
Not Important --------------------Moderately Important ------------------Most Important 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
5. How do you perceive your satisfaction level with the provided healthcare services at this 
hospital for hypertension? (Circle One) 
 
Not Satisfied --------------------- Moderate/Likely -----------------------Most Satisfied 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
6. How do you perceive your satisfaction level as a patient with your healthcare provider for 
managing and treating hypertension? (Circle One) 
 
Not Satisfied --------------------- Moderate/Likely -----------------------Most Satisfied 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
7. Please describe your diet pattern or the diet changes that you have adopted for managing 
hypertension? (e.g. food and restriction on salt intake) 
8. Do you regularly follow up with the doctor for BP check-up? (Circle One) 
i. 
Yes 
 
 
 
 
ii. No 
 
9. [Probe: Since your current diagnosis is of _____________.  Then ask the following 
questions:] 
i. 
How many years it’s been for seeking health care for hypertension: ____________ 
ii. 
How many years have been of seeking health care from this facility: ___________ 

9 
 
10. How do you rate the health care services in this healthcare facility: 
 
Not Satisfactory ------------------ Moderate/Likely ------------------Most Satisfactory 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11. What procedure you follow to get to a doctor for BP check up? Provide the details. 
12. Have you visited some other doctor for treating HTN before? If yes, then please provide 
details why the follow-up has been discontinued? 
13. Do you comply with the medicines? If yes, then how much? If no, they state the reasons. 
Please provide details. 
14. How do you manage hypertension yourself? Provide details. 
15. What type of life style pattern do you follow? 
i. Sedentary 
 
 
 
ii. Non-Sedentary 
16. What about lifestyle changes you have adopted and why? Concerning the aspects of 
exercise, diet, lifestyle modifications? 
17. Did your family members contribute towards managing hypertension? If yes then explain 
how? Who advised them? 
18. During the past 4 weeks, to what extent has your physical health or emotional problems 
interfered with your normal social activities with family, friends, neighbors, or groups? 
(Circle One) 
i. 
Not at all…………………………….………….1 
ii. 
Slightly………………………………………....2 
iii. 
Moderately……………………………………..3 
iv. 
Quite a bit………………………………………4 
v. 
Extremely………………………………………5 
 
19. Do you think family members are integral to manage hypertension of the patient? How 
much likely: 
 
Not Likely ----------------------- Moderate/Likely -------------------------Most Likely 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
20. What measures do you take for diet in relation to manage and treat hypertension? 
21. Do you do physical exercise for controlling hypertension? 
i. Yes  
 
 
 
ii. No 
22. Kindly give details how you do exercise and who advised it? Give details for complete 
timing of the way the physical exercise you do? 
 

10 
. 
 
23. During the past 4 weeks, have you had any of the following problems with your work or 
other regular daily activities as a result of your physical health? (Circle One)   Yes    No 
 
i. 
Cut down the amount of time you spent on work or other activities…      1        2 
ii. 
Accomplished less than you would like……………….……. 
         1        2 
iii. 
Were limited in the kind of work or other activities………………           1        2 
iv. 
Had difficulty performing the work or other activities 
(For example, it took extra effort)……………………….……            1        2  
 
24. During the past 4 weeks, have you had any of the following problems with your work or 
other regular daily activities as a result of any emotional problems (such as feeling 
depressed or anxious)? (Circle One) 
 
i. 
Cut down the amount of time you spent on work or other activity…..       1        2 
ii. 
Accomplished less than you would like…………………………….         1        2 
iii. 
Were limited in the kind of work or other activities…………….. 
         1        2 
iv. 
Had difficulty performing the work or other activities 
(For example, it took extra effort)……………………………             1        2  
 
25. How do you adhere to the prescribed medicines and if not, then provide the reasons for 
non-adherence to the prescribed treatment? 
26. [Probe about the smoking status and ask the following question] Have you taken any 
steps to quit smoking? If you have successfully quit smoking, what were the facilitators 
and barriers? 
27. How do you manage other co-morbidities along with hypertension?  
28. What alone as a component have helped to manage your blood pressure more? 
29. How TRUE or FALSE is each of the following statements for you. (Give one number on 
each line) 
 
Definitely true -------Mostly true------Don’t know-------Mostly false--------Definitely false 
 
1----------------2-------------------3------------------4---------------------5---------- 
i. 
I seem to get sick a little easier than other people…………….. 
_______ 
ii. 
I am as healthy as anybody I know……………………………. 
_______ 
iii. 
I expect my health to get worse……………………………….. 
_______ 
iv. 
My health is excellent………………………………………… 
_______ 
---------------------------------------------------------------------------------------------------------------- 
 
 

11 
 
Adapted from: 
1. Hays RD, Sherbourne CD, Mazel RM. The rand 36‐item health survey 1.0. Health economics. 1993 
Oct;2(3):217-27. 
2. Young DR, Coughlin J, Jerome GJ, Myers V, Chae SE, Brantley PJ. Effects of the PREMIER interventions 
on health-related quality of life. Annals of Behavioral Medicine. 2010 Aug 27;40(3):302-12. 
3. De Villiers MR. Three Approaches as Pillars for Interpretive Information Systems Research: Development 
Research. Action Research and Grounded Theory. In Bishop, J & D Konrie. Research for a Changing 
World." Proceedings of SAICSIT. 2005 Sep;2005:l42-5l. 
4. Abdel-Fattah MA. Grounded theory and action research as pillars for interpretive information systems 
research: A comparative study. Egyptian Informatics Journal. 2015 Nov 1;16(3):309-27. 
5. Jones CL, Jensen JD, Scherr CL, Brown NR, Christy K, Weaver J. The Health Belief Model as an 
explanatory framework in communication research: exploring parallel, serial, and moderated mediation. 
Health Commun. 2015;30(6):566–76. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25010519 
 
 

12 
. 
 
Appendice C: IDI: PHYSICIAN & SUBJECT EXPERTS 
 Time Allocation: The interview will last about 30-40 minutes 
 
Ground Rules  
 The interviewer and the note taker shall turn off their cell phones 
 Remain as neutral or impartial as possible  
 Use probes and clarifying questions where required 
 Avoid asking leading questions 
 Ensure all sections are covered 
 
Introduction: 
Asalam-o-Alaikum. Dear Dr. __________________________ 
 
I am Subhana Akber, PhD Scholar at Health Services Academy, Islamabad. My 
purpose to meet you today is for an in-depth interview regarding hypertension 
management and control. I thank you for providing me your valuable time to talk on the 
topic. You are requested to provide us your detailed information. I assure that your all 
information will be kept confidential and anonymous. Your interview and answers to the 
questions asked for this interview will be recorded after obtaining your consent. I thank 
you for your contribution to this study and for taking out few minutes from you precious 
time. You are requested to provide detailed information where deemed necessary and to 
give us your signed consent below: 
 
I. 
INTERVIEWEE’S PROFILE: 
Name: 
  
s/d/w 
  
Age: 
  
Gender: 
  
Qualifications: 
  
Current 
Designation: 
  
Affiliation: 
 
 
 
  
Total years of 
service: 
  
Email & 
Contact: 
  
Signature for Consent: 
Date:  _______________________ 

13 
 
IDI INTERVIEW 
SECTION 1: RAPPORT BUILDING 5 minutes 
 
1. Kindly inform us what criteria or protocol is followed for diagnosing hypertension? 
2. How hypertension is managed among hypertensive patients? 
3. How hypertensive patients are treated and what protocol is followed to treat hypertensive 
patients in your hospital? 
4. How much do you think it is important to screen patients for hypertension? What are the 
main reasons? 
 
SECTION 2: HYPERTENSION GUIDELINESS & POLICY CONTEXT 10 minutes 
5. Are you aware of any national or international policy regarding hypertension or its 
management? 
6. What guidelines are recommended? What guidelines are followed in practice? (e.g. NICE) 
 
SECTION 3: PRACTICES REGARDING HYPERTENSION Rx & MANAGEMENT 15 
minutes 
7. How the record of the patient’s follow up is maintained and kept? How often: 
a. Every week 
b. Every two weeks 
c. Other: __________________ 
8. How you measure the blood pressure of your patient? 
9. What is the recommended procedure to measure the blood pressure? 
10. How regularly your patients comply with your advice? What an average is the compliance 
rate? 
11. Do you provide awareness regarding hypertension to your patients? If not, then who is 
responsible to provide the awareness in your hospital? 
12. What measures do you take to counsel the hypertensive patients and provide them 
awareness? What awareness is provided to the patients? Kindly inform in detail: 
13. What are the facilitators & barriers: 
 In screening hypertension: 
 Prevention: 
 Diagnosis and Management: 
 Treating: 
14. Do you use any tools for predicting cardiovascular risk? 
 
SECTION 4: CONCLUSION 5 minutes 
15. How do you think hypertension can be prevented considering primary, secondary and 
tertiary levels of prevention? 
16. What benefits are gained by early detection of hypertension among patients? 
17. Do you have any recommendation? Or if you like to add something to the topic? 
 
WRAP UP INTERVIEW: 
Finally, I would like to thank you for providing us your valuable time. Your contribution is 
highly appreciated for this research work.

 
 
C. Appendix 
Study Questionnaire 
REGISTRATION OF BASIC DEMOGRAPHIC & CLINICAL DATA TO BE USED FOR RAPID ASSESSMENT AND FOLLOW-UP 
 
Patients Registration ID: 
__________________________________  
 
Date: ________________________ 
 
Sr. 
Q# 
Participant’s Baseline Characteristics 
2. 
Age (years): 
__________________________ 
 
Less than ≤30 years           
More than ≥60 years         
3.  
Marital Status: 
 
Unmarried                                  
Married                                      
Separated/divorced/prefer not to mention                 
 
4. 
 
Highest Education Level: 
 
No education                              
Matric/Intermediate                    
Graduate                                     
Postgraduate & higher                
 
5. 
Total household income (monthly): 
 
PKR: ______________________ 
6. 
 
Regular medical care provider: 
 
Public                                       
Private                                      
Specify:  _____________________________ 
 
 
7. 
 
Regular Provider: 
 
Doctor/GP                                 
Consultant/Specialist                 
 

2 
 
8. 
Any health insurance: 
 
Yes                       
No                        
 
If yes, please specify:  
 
 
________________________________ 
9. 
Cardiovascular risk assessment for high risk 
group: 
 
Family Hx                        years: __________ 
High BP                           years: __________ 
High Lipid profile            years: __________ 
 
*Mark unknown if patient does not knows 
 
10
. 
 
Anthropometric Measures: 
 
a. Height: _________________________ 
 
b. Weight: 
_________________________ 
 
c. BMI: 
_______________________________ 
 
*Reference Categories: 
 
Underweight: BMI is less than 18.5. 
Normal weight: BMI is 18.5 to 24.9. 
Overweight: BMI is 25 to 29.9. 
Obese: BMI is 30 or more. 
 
11. 
Smoking Status: 
 
Currently                                
Ex-Smoker                             
Occasionally                          
12. 
a. Years: 
__________________________________ 
 
b. Cigarettes per day: 
_______________________ 
13
. 
 
 
Family Size: Total household members 
 
_________________________________ 
 
14. 
 
Co-morbidities: 
 
Diabetes                                 
Cancer                                    
Congenital Abnormalities      
Others: 
 
______________________________ 
 
15. 
Life Style pattern 
 
Sedentary                    
Non-Sedentary            
16
. 
Physical Exercise 
 
Yes                             
No                               
 
If yes, specify minutes per 
day:_____________ 

3 
 
17. 
 
Pattern of Exercise: 
 
Walk 
Jogging/Running 
Yoga 
Others: __________________________ 
18. 
 
Category of regimen prescribed: 
 
Antihypertensive 
Cholesterol-lowering therapies 
Use of Aspirin 
Other, please specify:  
 
_____________________ 
19
. 
a. Total number of medicines taken: 
 
____________________ 
 
b. Dosage: 
 
OD                             
BD                             
TDS                           
 
20. 
 
Cost of medicines purchased (monthly): 
 
PKR: _____________________________ 
 
21. 
 
Occupation: 
 
Public Servant 
Private employee 
Laborer/Worker 
Other 
___________________________________ 
 
2. 
Years of HTN being diagnosed: 
 
Recently                              
Less than five years             
5-10 years                            
More than 10 years              
23. 
Hematological Findings: 
 
Lipid Profile (at baseline, 3 & 6 months): 
 
HDL     _______, __________, _________ 
LDL     _______, __________, _________ 
Triglycerides 
_______, __________, _________ 
 
Urea                       _______________________ 
Critenine                ________________________ 
Electrolytes:          _________________________ 
 
FBS Follow-up: 
At baseline       ______________________ 
At 1 months     _______________________ 
At 3 months 
24
. 
Disability due to HTN: 
CHD                                        
Hypercholesterolemia             
Blindness                                 
Stroke/Paralysis                       
Depression                               
Any other: ____________________ 
25.  
Presenting complaint/s: 

4 
 
26. 
Adverse Event (any reported) 
 
Yes                        No                       
27. 
 
AE Type (ever): 
 
IHD                                                 
Cardiac Arrest                                 
CHD/Angina                                   
Stroke                                              
Hemorrhage                                    
Other                                               
 
 
28. 
 
Food Intake 
 
Salt intake              Yes         No   
Red Meat                Yes         No   
Sugary items           Yes         No   
Beverages               Yes         No   
Sweets                    Yes         No   
Caffeine/Tea           Yes         No   
 
-------------------------------------------------------------------------------------------------------------------------------------