Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06148142 |
| Other study ID # |
2023D016 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
March 31, 2025 |
Study information
| Verified date |
November 2023 |
| Source |
Hitotsubashi University |
| Contact |
Md. Mizanur Rahman, PhD |
| Phone |
+818035463610 |
| Email |
mizanurrub78[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this multi-country research project is to reduce the blood pressure of individuals
with hypertension over a 12-month period in Bangladesh and Pakistan. A cluster randomized
controlled trial (cRCT) will be conducted with two arms. The estimated sample size is around
3600 hypertensive adults. Bangladesh study participants will consist of 3600 hypertensive
individuals. Approximately 10% of participants will be selected based on Bangladesh samples
from Pakistan (360 hypertensive patients, four pharmacies). Community pharmacies will be
randomised to one of two parallel groups (allocation ratio 1:1). Pharmacy professionals will
provide educational training and counselling, as well as phone calls/mobile text messages and
care coordination in the health sector as part of the intervention. The study will be
conducted in three phases: baseline survey; intervention and follow-up; and endline survey
with impact evaluation. The primary outcome will be BP reduction and the secondary outcomes
will be BP controlled to target, treatment adherence, mortality or hospital admission rates
resulting from hypertension and its related complications, incremental cost per
quality-adjusted life year gained, improvement in knowledge on healthy lifestyle, change in
dietary salt intake, and change in prevalence of current smokers.
Description:
Globally, hypertension is a leading cause of cardiovascular disease and death. Approximately
two-thirds of the world's 1.28 billion hypertensive adults live in low- and middle-income
countries (LMICs). South Asian countries have experienced a steep rise in hypertension
prevalence, with Bangladesh, India, and Pakistan having 48.0%, 52.3%, and 46.2%. Hypertension
in low-income countries is disproportionately caused by rapid urbanization, unhealthy
lifestyles, and inactivity. In LMICs, though awareness, treatment, and control of
hypertension remain unacceptably low, mostly because of poor medication adherence, limited
health resources, and difficulties accessing healthcare. Furthermore, a systematic review
suggested that factors such as inadequate health care information, dissatisfaction with the
services provided, and fewer interactions with physicians contribute significantly to
medication nonadherence. LMICs with weak health literacy, poor health systems, and high
cardiovascular disease fatality rates have a disproportionately high prevalence of
hypertension. Consequently, most hypertensive individuals take medications only when
symptomatic and lead sedentary lifestyles despite being aware of dietary recommendations.
Therefore, this study aims to evaluate the impact and cost-effectiveness of enhanced
pharmacist care on blood pressure (BP) control and treatment adherence across two South Asian
countries.
Objectives:
In this study, the investigator will test the effectiveness and cost-effectiveness of
enhanced pharmacy-based care provided to community people in two South Asian countries
(Bangladesh and Pakistan) on blood pressure control and treatment adherence. It is the first
multi-country trial to evaluate pharmacy-based health promotion in these two countries,
focusing on the role of pharmacist in hypertension treatment. This study hypothesizes that
hypertensive participants receiving the community pharmacy-based health intervention will
achieve the following:
- Reduced SBP and/or DBP;
- Treatment adherence and BP controlled to target (SBP 140 mmHg and DBP 90 mmHg)
increased;
- Cardiovascular disease, heart failure or stroke are less likely to cause
hospitalizations.
- Hypertension management costs are reduced;
- Changes in lifestyle behaviors, such as reducing salt intake, smoking, and physically
inactivity.
Methods:
Study design and setting:
Two-arm cluster randomized controlled trial (cRCT) will be conducted among hypertensive
subjects in Bangladesh and Pakistan. Randomization clusters are community pharmacies. Each
country will follow a two-arm cRCT design. According to 4.65% BP reduction with 49.78
standard deviation, the estimated sample size for Bangladesh is around 3600 at 80% power and
5% significance. Approximately 10% of participants will be selected based on Bangladesh
sample from Pakistan (360 hypertensive patients, four pharmacies). The average number of
hypertensive participants per pharmacy is 90.
Study participants:
As part of the census, participants who come to the pharmacy to purchase hypertensive
medication will be listed with their basic information. The following information will be
needed: their name, address, gender, duration of hypertension, who will be taking the
medication, and at least two contact numbers. In order to confirm whether prospective
hypertensive participants are hypertensive, their blood pressure will be measured again. Both
male and female participants will be invited to participate. The eligibility criteria
include: (1) aged 18 years and above, (2) hypertensive (defined (a) SBP ≥140 mmHg and DBP ≥90
mmHg and/or taking antihypertensive medications), (3) having suboptimal medication adherence
to antihypertensive drugs according to the Morisky Medication Adherence Scale, (4) capable of
communicating verbally in local language, (5) permanent resident of the study area, (6)
access to mobile phone, and (7) consent to participate. Exclusion criteria will be: (1)
pregnant and lactating women, (2) individuals with advanced medical disease, (3) those having
cognitive and psychiatric problems, (4) involvement in any other interventional study, and
(5) individuals who are unable to give informed consent. Pharmacists' inclusion criteria
include: (1) ensuring sufficient amount of time to implement intervention on hypertensive
participants, (2) consent to participate and (3) able to operate smartphone or tablet.
Screening for patients' eligibility will be conducted by the CP during regular visits, and
upon deeming them eligible, the CP will inform the principal investigator or research
assistant of this study to approach the patients, briefly explain the study, and ask to sign
informed consent.
Randomization: Community pharmacies will then be randomised to one of two parallel groups
(allocation ratio 1:1) using a computer-generated random number sequence. Participants and
pharmacies will be assigned to intervention and control groups in a 1:1 ratio.
Training of the pharmacists:
A mandatory communication training will enhance treatment integrity, since pharmacist skills
and competences will determine the quality of the intervention. Before the study begins, CP
in the intervention arm will receive a training involving both theoretical and practical
sessions. It will cover prevalence, risk factors, complications, and diagnosis of
hypertension, as well as non-pharmacological ways of preventing it. On the practical side,
CPs will learn how to measure blood pressure using a manual sphygmomanometer, interpret the
measurements, and educate and counsel hypertensive patients through audio-visual
presentations. As part of the intervention strategy, blood pressure control, identification
of hypertension-related complications, health education, medication and lifestyle
modification counselling, follow-up, and referral to a medical practitioner or hospital will
be provided.
