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

NCT02657746 | Unknown DMC

• 1 other identifier: MR/N006178/1
• Study Type: interventional
• Target: 2,550
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: 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. The goal of the full-scale study is to evaluate the effectiveness and cost-effectiveness of multicomponent primary care strategies on lowering blood pressure among adults with hypertension in rural communities in Bangladesh, Pakistan, and Sri Lanka. Methods/Design: The mixed-methods, stratified cluster randomized controlled trial Intervention: The multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension. Usual care: Will comprise existing services in the community without any additional training. Participants: The trial will be conducted on 2550 individuals aged 40 years or older with hypertension (systolic BP ≥ 140 mm Hg or diastolic BP≥ 90 mm Hg, or on antihypertensive therapy) in 30 rural communities of Bangladesh, Pakistan and Sri Lanka. Out of the 2550 individuals, 420 with poorly controlled BP (Systolic BP≥160 mmHg or Diastolic BP≥100 mmHg) will be selected, 14 from each community, to investigate the effect of MCI on results from ambulatory BP monitoring. Qualitative component: Stakeholders including policymakers, district managers, and community health workers, GPs, hypertensive individuals and family members in the identified clusters will be surveyed. Outcome: The primary outcome will be change in systolic BP from baseline to follow-up at 24 months post randomization. The cost effectiveness outcome is the incremental cost of MCI per unit reduction in BP over the two year time period and in terms of incremental cost per CVD DALYs averted.

Conditions

Hypertension

Keywords

blood pressure monitoring; high blood pressure; cardiovascular disease; Antihypertensive agents; Non-pharmacological treatment; community health care workers; cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Blood pressure reading:change in systolic blood pressure (SBP) from baseline to follow-up at 24 months post randomization.

  Blood pressure (BP) will measured at baseline and then at 6-month intervals until 24 months after randomization

Secondary Outcomes (20)

• Blood pressure reading:Blood Pressure(BP) controlled to target (Systolic BP <140 mm Hg and Diastolic BP <90 mm

  at 6-month intervals over 24 months

• Questionnaire:Composite outcome of death (all cause), or hospital admission due to coronary heart disease (CHD), heart failure, or stroke

  24 months

• Questionnaire and EQ-5D-5L:Incremental cost per quality-adjusted life-year (QALY) gained from baseline to end of follow-up

  24 months

• Morisky Medication Adherence Scale(MMAS):Change in antihypertensive medication adherence (Morisky score)

  24 months

• Height and weight measurements:change in body mass index ( BMI)

  24 months

Study Arms (2)

usual care

NO INTERVENTION

Usual care comprises existing services for hypertension control in the community without any additional training

multi-component interventions

EXPERIMENTAL

: The multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension.

Other: multi-component interventions

Interventions

multi-component interventions OTHER

The multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension.

multi-component interventions

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 last 2 of 3 readings from 2 separate days
• maintained on anti-hypertensive medications
• Informed consent

You may not qualify if:

• Permanently bed-ridden individuals too ill to commute to the clinic
• Pregnancy, or individuals with advanced medical disease (on dialysis, liver failure, other systemic diseases)
• Individuals that are mentally compromised and unable to give informed consent
• Sub-study:
• \) fulfill all criteria of main study and, 2) Persistently elevated systolic BP \>160 mm Hg or diastolic BP \>100 mm Hg from each set of 2 readings from 2 separate days

Sponsors & Collaborators

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

Related Publications (7)

• Feng L, Jehan I, de Silva HA, Naheed A, Khan AH, Kasturiratne A, Clemens JD, Lim CW, Hughes AD, Chaturvedi N, Jafar TH. Effect of a Multicomponent Intervention on Antihypertensive Medication Intensification in Rural South Asia: Post Hoc Analysis of a Cluster RCT. Am J Hypertens. 2021 Sep 22;34(9):981-988. doi: 10.1093/ajh/hpab072.

  PMID: 34013966 DERIVED

• Jafar TH, Gandhi M, de Silva HA, Jehan I, Naheed A, Finkelstein EA, Turner EL, Morisky D, Kasturiratne A, Khan AH, Clemens JD, Ebrahim S, Assam PN, Feng L; COBRA-BPS Study Group. A Community-Based Intervention for Managing Hypertension in Rural South Asia. N Engl J Med. 2020 Feb 20;382(8):717-726. doi: 10.1056/NEJMoa1911965.

  PMID: 32074419 DERIVED

• Perera M, de Silva CK, Tavajoh S, Kasturiratne A, Luke NV, Ediriweera DS, Ranasinha CD, Legido-Quigley H, de Silva HA, Jafar TH. Patient perspectives on hypertension management in health system of Sri Lanka: a qualitative study. BMJ Open. 2019 Oct 7;9(10):e031773. doi: 10.1136/bmjopen-2019-031773.

  PMID: 31594895 DERIVED

• Gandhi M, Assam PN, Turner EL, Morisky DE, Chan E, Jafar TH; COBRA-BPS Study Group. Statistical analysis plan for the control of blood pressure and risk attenuation-rural Bangladesh, Pakistan, Sri Lanka (COBRA-BPS) trial: a cluster randomized trial for a multicomponent intervention versus usual care in hypertensive patients. Trials. 2018 Nov 29;19(1):658. doi: 10.1186/s13063-018-3022-8.

  PMID: 30486858 DERIVED

• Feng L, de Silva HA, Jehan I, Naheed A, Kasturiratne A, Himani G, Hasnat MA, Jafar TH. Regional variation in chronic kidney disease and associated factors in hypertensive individuals in rural South Asia: findings from control of blood pressure and risk attenuation-Bangladesh, Pakistan and Sri Lanka. Nephrol Dial Transplant. 2019 Oct 1;34(10):1723-1730. doi: 10.1093/ndt/gfy184.

  PMID: 29982770 DERIVED

• Jafar TH, Gandhi M, Jehan I, Naheed A, de Silva HA, Shahab H, Alam D, Luke N, Wee Lim C; COBRA-BPS Study Group. Determinants of Uncontrolled Hypertension in Rural Communities in South Asia-Bangladesh, Pakistan, and Sri Lanka. Am J Hypertens. 2018 Oct 15;31(11):1205-1214. doi: 10.1093/ajh/hpy071.

  PMID: 29701801 DERIVED

• Jafar TH, Jehan I, de Silva HA, Naheed A, Gandhi M, Assam P, Finkelstein EA, Quigley HL, Bilger M, Khan AH, Clemens JD, Ebrahim S, Turner EL; for COBRA-BPS Study Group; Kasturiratne A. Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial. Trials. 2017 Jun 12;18(1):272. doi: 10.1186/s13063-017-2018-0.

  PMID: 28606184 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Tazeen H Jafar, MD,MPH

  Duke-NUS Graduate Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 18, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: October 31, 2019

Record last verified: 2019-10