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

• ClinicalTrials.gov Identifier: NCT02657746
• Recruitment Status: Unknown
• First Posted: January 18, 2016
• Last Update Posted: March 3, 2017
• Sponsor: Duke-NUS Graduate Medical School
• Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh; Aga Khan University; University of Kelaniya
• Information provided by (Responsible Party): Professor Tazeen Jafar, Duke-NUS Graduate Medical School

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Other: multi-component interventions	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 2550 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Primary Care Strategies to Reduce High Blood Pressure: A Cluster Randomized Trial in Rural Bangladesh, Pakistan and Sri Lanka
• Actual Study Start Date: May 1, 2016
• Estimated Primary Completion Date: March 2019
• Estimated Study Completion Date: March 2019

Arms and Interventions

Arm	Intervention/treatment
No Intervention: usual care; Usual care comprises existing services for hypertension control in the community without any additional training
Experimental: multi-component interventions; : 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Blood pressure reading:change in systolic blood pressure (SBP) from baseline to follow-up at 24 months post randomization. [ Time Frame: Blood pressure (BP) will measured at baseline and then at 6-month intervals until 24 months after randomization ]
2. Questionnaire and EQ-5D-5L:Incremental cost per mm Hg BP reduction from baseline to end of follow-up at two years post randomization and incremental cost per projected cardiovascular disease ( CVD) disability adjusted life year (DALY) averted [ Time Frame: information on healthcare cost will be collected at baseline and 24 months ]
3. 24 hour mean systolic BP in the studied cohort [ Time Frame: Ambulatory Blood pressure (BP) will be measured at baseline and then yearly until 2 years after randomization ]
   primary outcome for the sub-study of 420 patients with poorly controlled BP at baseline

Secondary Outcome Measures :

1. Blood pressure reading:Blood Pressure(BP) controlled to target (Systolic BP <140 mm Hg and Diastolic BP <90 mm [ Time Frame: at 6-month intervals over 24 months ]
2. Questionnaire:Composite outcome of death (all cause), or hospital admission due to coronary heart disease (CHD), heart failure, or stroke [ Time Frame: 24 months ]
3. Questionnaire and EQ-5D-5L:Incremental cost per quality-adjusted life-year (QALY) gained from baseline to end of follow-up [ Time Frame: 24 months ]
4. Morisky Medication Adherence Scale(MMAS):Change in antihypertensive medication adherence (Morisky score) [ Time Frame: 24 months ]
5. Height and weight measurements:change in body mass index ( BMI) [ Time Frame: 24 months ]
6. questionnaire:change dietary salt intake (urinary excretion) [ Time Frame: 24 months ]
7. Questionnaire:change in prevalence of current smokers [ Time Frame: 24 months ]
8. Questionnaire:incident diabetes [ Time Frame: 24 months ]
9. Lipid panel: change in serum lipid levels [ Time Frame: 24 months ]
10. questionnaire: change in INTERHEART cardiovascular disease (CVD) risk score [ Time Frame: 24 months ]
11. Questionnaire:incidence of adverse outcomes (medication side effects, sick days absenteeism, low QALY between randomized groups). [ Time Frame: 24 months ]
12. Questionnaire and serum creatinine:Change in estimated glomerular filtration rate (eGFR) [ Time Frame: 24 months ]
13. Urine albumin:Change in urine albumin [ Time Frame: 24 months ]
14. 24 hours mean diastolic BP [ Time Frame: 24 months ]
    Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
15. Daytime SBP/DBP [ Time Frame: 24 months ]
    secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
16. Night time SBP/DBP [ Time Frame: 24 months ]
    Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
17. Dipping Pattern [ Time Frame: 24 months ]
    Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
18. 24 hour BP variability [ Time Frame: 24 months ]
    Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Main study:

Inclusion Criteria:

1. Age≥ 40 years
2. Residing in the selected clusters

3. Hypertension defined either as:

   1. 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
   2. maintained on anti-hypertensive medications
4. Informed consent

Exclusion Criteria:

1. Permanently bed-ridden individuals too ill to commute to the clinic
2. Pregnancy, or individuals with advanced medical disease (on dialysis, liver failure, other systemic diseases)
3. Individuals that are mentally compromised and unable to give informed consent

Sub-study:

1) 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

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Contacts and Locations

Sponsors and Collaborators

Duke-NUS Graduate Medical School

International Centre for Diarrhoeal Disease Research, Bangladesh

Aga Khan University

University of Kelaniya

Investigators

• Principal Investigator: Tazeen H Jafar, MD,MPH; Duke-NUS Medical School (Singapore)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Feng L, de Silva HA, Jehan I, Naheed A, Kasturiratne A, Himani G, Hasnat MA, Jafar TH; COBRA-BPS Study Group. 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. 2018 Jul 5. doi: 10.1093/ndt/gfy184. [Epub ahead of print]

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.

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.

• Responsible Party: Professor Tazeen Jafar, Professor, Duke-NUS Graduate Medical School
• ClinicalTrials.gov Identifier: NCT02657746 History of Changes
• Other Study ID Numbers: MR/N006178/1
• First Posted: January 18, 2016
• Last Update Posted: March 3, 2017
• Last Verified: March 2017

Keywords provided by Professor Tazeen Jafar, Duke-NUS Graduate Medical School:

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

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases