Clinical trial NCT02657746: Primary Care Strategies to Reduce High Blood Pressure: A Cluster Randomized Trial in Rural Bangladesh, Pakistan and Sri Lanka
Official title: Control of Blood Pressure and Risk Attenuation-Bangladesh, Pakistan and Sri Lanka (COBRA-BPS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: blood pressure monitoring
high blood pressure
cardiovascular disease
Antihypertensive agents
Non-pharmacological treatment
community health care workers
cost-effectiveness
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Aga Khan University
name: University of Kelaniya
First posted: 2016-01-18
Enrollment: 2550
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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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Primary outcomes:
measure: Blood pressure reading:change in systolic blood pressure (SBP) from baseline to follow-up at 24 months post randomization.
timeFrame: Blood pressure (BP) will measured at baseline and then at 6-month intervals until 24 months after randomization
Secondary outcomes:
measure: Blood pressure reading:Blood Pressure(BP) controlled to target (Systolic BP <140 mm Hg and Diastolic BP <90 mm
timeFrame: at 6-month intervals over 24 months
measure: Questionnaire:Composite outcome of death (all cause), or hospital admission due to coronary heart disease (CHD), heart failure, or stroke
timeFrame: 24 months
measure: Questionnaire and EQ-5D-5L:Incremental cost per quality-adjusted life-year (QALY) gained from baseline to end of follow-up
timeFrame: 24 months
measure: Morisky Medication Adherence Scale(MMAS):Change in antihypertensive medication adherence (Morisky score)
timeFrame: 24 months
measure: Height and weight measurements:change in body mass index ( BMI)
timeFrame: 24 months
measure: questionnaire:change dietary salt intake (urinary excretion)
timeFrame: 24 months
measure: Questionnaire:change in prevalence of current smokers
timeFrame: 24 months
measure: Questionnaire:incident diabetes
timeFrame: 24 months
measure: Lipid panel: change in serum lipid levels
timeFrame: 24 months
measure: questionnaire: change in INTERHEART cardiovascular disease (CVD) risk score
timeFrame: 24 months
measure: Questionnaire:incidence of adverse outcomes (medication side effects, sick days absenteeism, low QALY between randomized groups).
timeFrame: 24 months
measure: Questionnaire and serum creatinine:Change in estimated glomerular filtration rate (eGFR)
timeFrame: 24 months
measure: Urine albumin:Change in urine albumin
timeFrame: 24 months
measure: 24 hours mean diastolic BP
timeFrame: 24 months
measure: Daytime SBP/DBP
timeFrame: 24 months
measure: Night time SBP/DBP
timeFrame: 24 months
measure: Dipping Pattern
timeFrame: 24 months
measure: 24 hour BP variability
timeFrame: 24 months
measure: 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
timeFrame: information on healthcare cost will be collected at baseline and 24 months
measure: incremental cost per mm Hg BP reduction from baseline to end of follow-up at 2 years post-randomization and incremental cost per projected CVD disability-adjusted life year (DALY) averted
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Tazeen H Jafar, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.