Control of Blood Pressure and Risk Attenuation-rural Bangladesh, Pakistan, Sri Lanka, Feasibility Study

NCT02341651 | Completed DMC

• 1 other identifier: MR/L004224/1
• Study Type: interventional
• Target: 453
• Locations: 3 countries
• Sites: 3

Brief Summary

High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD). In rural South Asia, hypertension remains to be a significant public health issue with sub-optimal rates of case finding and management. A trial to investigate integrated primary care strategies to control hypertension is planned. Packaged interventions for the planned full-scale study are varying combinations of 1) home health education (HHE) by trained community health workers (CHW), 2) trained government primary health centre mid-level providers (MLP) led care and 3) trained private practitioners. The goal of the full-scale study is to test which combination of the above interventions is the most effective in lowering blood pressure among adults with hypertension in rural communities. In addition, the full-scale study aims to quantify the incremental cost- effectiveness of each approach in terms of cost per projected cardiovascular disease (CVD) disability adjusted life-years (DALYs) averted.

Conditions

Hypertension

Keywords

High blood pressure; Cardiovascular diseases; Antihypertensive agents; Pharmacological treatment; Non-pharmacological treatment; Community health care workers; Treatment algorithm; Public and private healthcare providers; Strategy; Referral loops; Intervention

Outcome Measures

Primary Outcomes (1)

• retention rate

  proportion of hypertensive individuals followed up at 3 months in 3 countries

  3 months

Secondary Outcomes (4)

• Fidelity measure- Proportion of providers trained

  3 months

• Fidelity measure- home health education sessions delivered

  3 months

• fidelity measure 3- physician management checklist collected

  3 months

• Baseline to follow-up change in systolic blood pressure level

  3 months

Study Arms (2)

Multicomponent "combination"

EXPERIMENTAL

Multicomponent intervention is a combination of the following 1) community health worker (CHW)- led blood pressure (BP) screening and referral to provider, plus 2) home health education (HHE) adapted to the local diet by trained CHW plus 3) trained primary health center mid-level providers (MLP) and physicians using evidence-based treatment algorithm of BP lowering in all and lipid lowering for high risk, plus 4) process-based incentives

Other: Multicomponent intervention

Usual Care

NO INTERVENTION

No active intervention

Interventions

Multicomponent intervention OTHER

Multicomponent intervention is a combination of the following 1) community health worker (CHW)- led blood pressure (BP) screening and referral to provider, plus 2) home health education (HHE) adapted to the local diet by trained CHW plus 3) trained primary health center mid-level providers (MLP) and physicians using evidence-based treatment algorithm of BP lowering in all and lipid lowering for high risk, plus 4) process-based incentives

Multicomponent "combination"

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥ 40 years
• Residing in the selected clusters
• Hypertension defined either as:
• persistently elevated BP (systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg) from each set of 2 readings from 2 separate days
• maintained on anti-hypertensive medications
• Informed consent

You may not qualify if:

• Bed-ridden individuals too ill to commute to the clinic
• Individuals with advanced medical disease (on dialysis, liver failure, other systemic diseases)
• Individuals that are mentally compromised and unable to give informed consent

Sponsors & Collaborators

• Duke-NUS Graduate Medical School: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Aga Khan University: collaborator
• University of Kelaniya: collaborator

Study Sites (3)

Initiative for Non-Communicable Diseases icddr,b

Dhaka, Mohakhali, 1212, Bangladesh

Location

Aga Khan University Hospital

Karachi, Karachi, 74800, Pakistan

Location

University of Kelaniya

Ragama, Ragama, Sri Lanka

Location

Related Publications (1)

• Jafar TH, Silva Ad, Naheed A, Jehan I, Liang F, Assam PN, Legido-Quigley H, Finkelstein EA, Ebrahim S, Wickremasinghe R, Alam D, Khan AH; COBRA-BPS Study Group. Control of blood pressure and risk attenuation: a public health intervention in rural Bangladesh, Pakistan, and Sri Lanka: feasibility trial results. J Hypertens. 2016 Sep;34(9):1872-81. doi: 10.1097/HJH.0000000000001014.

  PMID: 27488552 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Tazeen H Jafar, MD, MPH

  Duke-NUS, Singapore

  PRINCIPAL INVESTIGATOR

• Aliya Naheed

  Initiative for Non-Communicable Diseases icddr,b, Bangladesh

  PRINCIPAL INVESTIGATOR

• Imtiaz Jehan

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Asita de Silva

  University of Kelaniya, Sri Lanka

  PRINCIPAL INVESTIGATOR

• Shah Ebrahim

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2014
• First Posted: January 19, 2015
• Study Start: August 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

SR (1); BA (1); PA (1)