Home » Trials » SLCTR/2016/005
Primary Care Strategies to Reduce High Blood Pressure: A Cluster Randomized Trial in Rural Bangladesh, Pakistan and Sri Lanka
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SLCTR Registration Number
SLCTR/2016/005
Date of Registration
The date of last modification
Mar 03, 2019
View original TRDS
Trial Status
Scientific Title of Trial
Primary Care Strategies to Reduce High Blood Pressure: A Cluster Randomized Trial in Rural Bangladesh, Pakistan and Sri Lanka
Public Title of Trial
Control of Blood Pressure and Risk Attenuation- Bangladesh, Pakistan & Sri Lanka
Disease or Health Condition(s) Studied
Hypertension
Scientific Acronym
COBRA
Public Acronym
COBRA
Brief title
Control of Blood Pressure and Risk Attenuation- Bangladesh, Pakistan & Sri Lanka
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
ERC (Kelaniya) P/179/11/2015
What is the research question being addressed?
Is a multi-component intervention strategy more effective relative to usual care in lowering blood pressure of adults with hypertension in rural communities in Bangladesh, Pakistan, and Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
1). Study setting- will be carried out selected clusters in Puttalam District. Randomization will be stratified by the distance from the government clinic, and clusters will be randomized in a 1:1 ratio to either intervention or usual care, using a computer generated randomization program. A minimum distance of 10 km between randomized clusters will be ensured.
2). Number of arms- two arms
3). Multi component intervention It is an intervention which is a combination of the following
1. Home health education (HHE) by government community health workers (CHWs), to be provided every 3 months for 2 years
2. Blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, every 3 months for 2 years
3.Training public and private providers in management of hypertension and using a checklist, every 3 months for 2 years
4. Designating hypertension triage counter and hypertension care coordinators in government clinics
5. A financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension
Standard care will comprise existing services (pharmacological and non-pharmacological) in the community without any additional training.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Change in systolic blood pressure from baseline to final follow-up at two year post randomization (both measurements by independent data collectors who will be masked to randomization). Primary cost-effectiveness measure Incremental cost per mm Hg BP reduction from baseline to end of follow-up at two years post randomization and incremental cost per projected CVD disability adjusted life year (DALY) averted. |
[ At two years post randomization ] |
Secondary outcome(s)
|
1.
BP controlled to target (SBP <140 mm Hg and DBP <90 mm Hg). 2. Composite outcome of death (all cause) 3. Hospital admission due to CHD, heart failure, or stroke 4. Change in antihypertensive medication adherence (Morisky score) 5. Change in BMI, dietary salt intake (urinary excretion) 6. Prevalence of current smokers, incident diabetes, serum lipid levels, and interheart CVD risk score from baseline to final follow-up at two year post randomization 7. Incidence of adverse outcomes (medication side effects, sick days absenteeism, low DALY between randomized groups) 8. Secondary cost-effectiveness measure: Incremental cost per DALY gained from baseline to end of follow-up. |
[ Two years post-randomization ] |
Target number/sample size
850 subjects from Sri Lanka (425 in each arm)
Countries of recruitment
Bangladesh, Pakistan, Sri Lanka
Anticipated start date
2016-03-01
Anticipated end date
2019-02-01
Date of first enrollment
2016-05-08
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
• Welcome Trust, UK • Medical Research Council, UK • UK Department for International Development
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2015-11-18
Approval number
P/179/11/2015
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof Asita de Silva
Director
Clinical Trials Unit, Department of Pharmacology, Faculty of Medicine, University of Kelaniya Thalagolla Road, Ragama, Sri Lanka
Tel: +94 112665266
asitades@gmail.com
Contact Person for Public Queries
Dr Anuradani Kasturiratne
Senior Lecturer
Department of Pharmacology, Faculty of Medicine, University of Kelaniya
Tel: +94 11-2961140
anuradhani@kln.ac.lk
Primary study sponsor/organization
Professor Tazeen Jafar
(Lead Principal Investigator)
Duke-NUS Graduate Medical School, Singapore
tazeen.jafar@duke-nus.edu.sg
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
