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Primary Care Strategies to Reduce High Blood Pressure: A Cluster Randomized Trial in Rural Bangladesh, Pakistan and Sri Lanka -

SLCTR Registration Number

SLCTR/2016/005


Date of Registration

16 Feb 2016

The date of last modification

Jan 27, 2017


View original TRDS


Trial Status



Application Summary


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 of 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


Trial Details


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


Assignment

Parallel


Purpose

Health services research


Purpose


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

  1. Age >40 years
  2. Residing in the selected clusters in Puttalam District
  3. Hypertension defined either as: a).Persistently elevated BP (systolic BP ?140 mm Hg or diastolic BP ?90 mm Hg) from each set of last 2 of 3 readings from 2 separate days
    b). Maintained on anti-hypertensive medications

Exclusion criteria

  1. Permanently bed-ridden individuals too ill to commute to the clinic
  2. Pregnancy, individuals with advanced medical disease (on dialysis, liver failure, other systemic diseases)


Primary outcome(s)

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.


Primary outcome(s) - Time of assessment(s)

At two years post randomization


Secondary outcome

  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.

Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Complete


State of ethics review approval

Approved by Ethics Review Committee, Faculty of Medicine, University of Kelaniya on 18 Nov 2015 (ref P/179/11/2015)


Funding source

• Welcome Trust, UK • Medical Research Council, UK • UK Department for International Development



Contact & Sponsor Information


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

Secondary study sponsor (If any)

None