Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02657746
Recruitment Status : Enrolling by invitation
First Posted : January 18, 2016
Last Update Posted : October 31, 2019
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE January 14, 2016
First Posted Date  ICMJE January 18, 2016
Last Update Posted Date October 31, 2019
Actual Study Start Date  ICMJE May 1, 2016
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2016)
  • change in systolic BP from baseline to follow-up at 24 months post randomization. [ Time Frame: BP will measured at baseline and then at 6-month invtervals until 24 months after randomization ]
  • 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 [ Time Frame: information on healthcare cost will be collected at baseline and 24 months ]
Change History Complete list of historical versions of study NCT02657746 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
  • 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 ]
  • Questionnaire:Composite outcome of death (all cause), or hospital admission due to coronary heart disease (CHD), heart failure, or stroke [ Time Frame: 24 months ]
  • 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 ]
  • Morisky Medication Adherence Scale(MMAS):Change in antihypertensive medication adherence (Morisky score) [ Time Frame: 24 months ]
  • Height and weight measurements:change in body mass index ( BMI) [ Time Frame: 24 months ]
  • questionnaire:change dietary salt intake (urinary excretion) [ Time Frame: 24 months ]
  • Questionnaire:change in prevalence of current smokers [ Time Frame: 24 months ]
  • Questionnaire:incident diabetes [ Time Frame: 24 months ]
  • Lipid panel: change in serum lipid levels [ Time Frame: 24 months ]
  • questionnaire: change in INTERHEART cardiovascular disease (CVD) risk score [ Time Frame: 24 months ]
  • Questionnaire:incidence of adverse outcomes (medication side effects, sick days absenteeism, low QALY between randomized groups). [ Time Frame: 24 months ]
  • Questionnaire and serum creatinine:Change in estimated glomerular filtration rate (eGFR) [ Time Frame: 24 months ]
  • Urine albumin:Change in urine albumin [ Time Frame: 24 months ]
  • 24 hours mean diastolic BP [ Time Frame: 24 months ]
    Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
  • Daytime SBP/DBP [ Time Frame: 24 months ]
    secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
  • Night time SBP/DBP [ Time Frame: 24 months ]
    Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
  • Dipping Pattern [ Time Frame: 24 months ]
    Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
  • 24 hour BP variability [ Time Frame: 24 months ]
    Secondary outcome for the sub-study of 420 patients with poorly controlled BP at baseline
  • 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 ]
  • 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 [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2016)
  • BP controlled to target (SBP <140 mm Hg and DBP <90 mm [ Time Frame: at 6-month intervals over 24 months ]
  • Composite outcome of death (all cause), or hospital admission due to CHD, heart failure, or stroke [ Time Frame: 24 months ]
  • Incremental cost per QALY gained from baseline to end of follow-up [ Time Frame: 24 months ]
  • Change in antihypertensive medication adherence (Morisky score) [ Time Frame: 24 months ]
  • change in BMI [ Time Frame: 24 months ]
  • change dietary salt intake (urinary excretion) [ Time Frame: 24 months ]
  • change in prevalence of current smokers [ Time Frame: 24 months ]
  • incident diabetes [ Time Frame: 24 months ]
  • change in serum lipid levels [ Time Frame: 24 months ]
  • change in INTERHEART CVD risk score [ Time Frame: 24 months ]
  • incidence of adverse outcomes (medication side effects, sick days absenteeism, low QALY between randomized groups). [ Time Frame: 24 months ]
  • Change in eGFR [ Time Frame: 24 months ]
  • Change in urine albumin [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Primary Care Strategies to Reduce High Blood Pressure: A Cluster Randomized Trial in Rural Bangladesh, Pakistan and Sri Lanka
Official Title  ICMJE Control of Blood Pressure and Risk Attenuation-Bangladesh, Pakistan and Sri Lanka (COBRA-BPS)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Hypertension
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: multi-component interventions
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: January 15, 2016)
2550
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02657746
Other Study ID Numbers  ICMJE MR/N006178/1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Tazeen Jafar, Duke-NUS Graduate Medical School
Study Sponsor  ICMJE Duke-NUS Graduate Medical School
Collaborators  ICMJE
  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Aga Khan University
  • University of Kelaniya
Investigators  ICMJE
Principal Investigator: Tazeen H Jafar, MD,MPH Duke-NUS Medical School (Singapore)
PRS Account Duke-NUS Graduate Medical School
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP