Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial

BACKGROUND: High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD). In rural South Asia, hypertension continues to be a significant public health issue with sub-optimal BP control rates. The goal of the trial is to compare a multicomponent intervention (MCI) to us...

Descripción completa

Detalles Bibliográficos
Autores principales: Jafar, Tazeen H., Jehan, Imtiaz, de Silva, H. Asita, Naheed, Aliya, Gandhi, Mihir, Assam, Pryseley, Finkelstein, Eric A., Quigley, Helena Legido, Bilger, Marcel, Khan, Aamir Hameed, Clemens, John David, Ebrahim, Shah, Turner, Elizabeth L., Kasturiratne, Anuradhani
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5469065/
https://www.ncbi.nlm.nih.gov/pubmed/28606184
http://dx.doi.org/10.1186/s13063-017-2018-0
_version_ 1783243513982353408
author Jafar, Tazeen H.
Jehan, Imtiaz
de Silva, H. Asita
Naheed, Aliya
Gandhi, Mihir
Assam, Pryseley
Finkelstein, Eric A.
Quigley, Helena Legido
Bilger, Marcel
Khan, Aamir Hameed
Clemens, John David
Ebrahim, Shah
Turner, Elizabeth L.
Kasturiratne, Anuradhani
author_facet Jafar, Tazeen H.
Jehan, Imtiaz
de Silva, H. Asita
Naheed, Aliya
Gandhi, Mihir
Assam, Pryseley
Finkelstein, Eric A.
Quigley, Helena Legido
Bilger, Marcel
Khan, Aamir Hameed
Clemens, John David
Ebrahim, Shah
Turner, Elizabeth L.
Kasturiratne, Anuradhani
author_sort Jafar, Tazeen H.
collection PubMed
description BACKGROUND: High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD). In rural South Asia, hypertension continues to be a significant public health issue with sub-optimal BP control rates. The goal of the trial is to compare a multicomponent intervention (MCI) to usual care to evaluate the effectiveness and cost-effectiveness of the MCI for lowering BP among adults with hypertension in rural communities in Bangladesh, Pakistan and Sri Lanka. METHODS/DESIGN: This study is a stratified, cluster randomized controlled trial with a qualitative component for evaluation of processes and stakeholder feedback. The MCI has five components: (1) home health education by government community health workers (CHWs), (2) BP monitoring and stepped-up referral to a trained general practitioner using a checklist, (3) training public and private providers in management of hypertension and using a checklist, (4) designating hypertension triage counter and hypertension care coordinators in government clinics and (5) a financing model to compensate for additional health services and provide subsidies to low income individuals with poorly controlled hypertension. Usual care will comprise existing services in the community without any additional training. The trial will be conducted on 2550 individuals aged ≥40 years with hypertension (with systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg, based on the mean of the last two of three measurements from two separate days, or on antihypertensive therapy) in 30 rural communities in Bangladesh, Pakistan and Sri Lanka. The primary outcome is change in systolic BP from baseline to follow-up at 24 months post-randomization. The incremental cost of MCI per CVD disability-adjusted life years averted will be computed. Stakeholders including policy makers, provincial- and district-level coordinators of relevant programmes, physicians, CHWs, key community leaders, hypertensive individuals and family members in the identified clusters will be interviewed. DISCUSSION: The study will provide evidence of the effectiveness and cost-effectiveness of MCI strategies for BP control compared to usual care in the rural public health infrastructure in South Asian countries. If shown to be successful, MCI may be a long-term sustainable strategy for tackling the rising rates of CVD in low resourced countries. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02657746. Registered on 14 January 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2018-0) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-5469065
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-54690652017-06-14 Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial Jafar, Tazeen H. Jehan, Imtiaz de Silva, H. Asita Naheed, Aliya Gandhi, Mihir Assam, Pryseley Finkelstein, Eric A. Quigley, Helena Legido Bilger, Marcel Khan, Aamir Hameed Clemens, John David Ebrahim, Shah Turner, Elizabeth L. Kasturiratne, Anuradhani Trials Study Protocol BACKGROUND: High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD). In rural South Asia, hypertension continues to be a significant public health issue with sub-optimal BP control rates. The goal of the trial is to compare a multicomponent intervention (MCI) to usual care to evaluate the effectiveness and cost-effectiveness of the MCI for lowering BP among adults with hypertension in rural communities in Bangladesh, Pakistan and Sri Lanka. METHODS/DESIGN: This study is a stratified, cluster randomized controlled trial with a qualitative component for evaluation of processes and stakeholder feedback. The MCI has five components: (1) home health education by government community health workers (CHWs), (2) BP monitoring and stepped-up referral to a trained general practitioner using a checklist, (3) training public and private providers in management of hypertension and using a checklist, (4) designating hypertension triage counter and hypertension care coordinators in government clinics and (5) a financing model to compensate for additional health services and provide subsidies to low income individuals with poorly controlled hypertension. Usual care will comprise existing services in the community without any additional training. The trial will be conducted on 2550 individuals aged ≥40 years with hypertension (with systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg, based on the mean of the last two of three measurements from two separate days, or on antihypertensive therapy) in 30 rural communities in Bangladesh, Pakistan and Sri Lanka. The primary outcome is change in systolic BP from baseline to follow-up at 24 months post-randomization. The incremental cost of MCI per CVD disability-adjusted life years averted will be computed. Stakeholders including policy makers, provincial- and district-level coordinators of relevant programmes, physicians, CHWs, key community leaders, hypertensive individuals and family members in the identified clusters will be interviewed. DISCUSSION: The study will provide evidence of the effectiveness and cost-effectiveness of MCI strategies for BP control compared to usual care in the rural public health infrastructure in South Asian countries. If shown to be successful, MCI may be a long-term sustainable strategy for tackling the rising rates of CVD in low resourced countries. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02657746. Registered on 14 January 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2018-0) contains supplementary material, which is available to authorized users. BioMed Central 2017-06-12 /pmc/articles/PMC5469065/ /pubmed/28606184 http://dx.doi.org/10.1186/s13063-017-2018-0 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Jafar, Tazeen H.
Jehan, Imtiaz
de Silva, H. Asita
Naheed, Aliya
Gandhi, Mihir
Assam, Pryseley
Finkelstein, Eric A.
Quigley, Helena Legido
Bilger, Marcel
Khan, Aamir Hameed
Clemens, John David
Ebrahim, Shah
Turner, Elizabeth L.
Kasturiratne, Anuradhani
Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial
title Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial
title_full Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial
title_fullStr Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial
title_full_unstemmed Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial
title_short Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial
title_sort multicomponent intervention versus usual care for management of hypertension in rural bangladesh, pakistan and sri lanka: study protocol for a cluster randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5469065/
https://www.ncbi.nlm.nih.gov/pubmed/28606184
http://dx.doi.org/10.1186/s13063-017-2018-0
work_keys_str_mv AT jafartazeenh multicomponentinterventionversususualcareformanagementofhypertensioninruralbangladeshpakistanandsrilankastudyprotocolforaclusterrandomizedcontrolledtrial
AT jehanimtiaz multicomponentinterventionversususualcareformanagementofhypertensioninruralbangladeshpakistanandsrilankastudyprotocolforaclusterrandomizedcontrolledtrial
AT desilvahasita multicomponentinterventionversususualcareformanagementofhypertensioninruralbangladeshpakistanandsrilankastudyprotocolforaclusterrandomizedcontrolledtrial
AT naheedaliya multicomponentinterventionversususualcareformanagementofhypertensioninruralbangladeshpakistanandsrilankastudyprotocolforaclusterrandomizedcontrolledtrial
AT gandhimihir multicomponentinterventionversususualcareformanagementofhypertensioninruralbangladeshpakistanandsrilankastudyprotocolforaclusterrandomizedcontrolledtrial
AT assampryseley multicomponentinterventionversususualcareformanagementofhypertensioninruralbangladeshpakistanandsrilankastudyprotocolforaclusterrandomizedcontrolledtrial
AT finkelsteinerica multicomponentinterventionversususualcareformanagementofhypertensioninruralbangladeshpakistanandsrilankastudyprotocolforaclusterrandomizedcontrolledtrial
AT quigleyhelenalegido multicomponentinterventionversususualcareformanagementofhypertensioninruralbangladeshpakistanandsrilankastudyprotocolforaclusterrandomizedcontrolledtrial
AT bilgermarcel multicomponentinterventionversususualcareformanagementofhypertensioninruralbangladeshpakistanandsrilankastudyprotocolforaclusterrandomizedcontrolledtrial
AT khanaamirhameed multicomponentinterventionversususualcareformanagementofhypertensioninruralbangladeshpakistanandsrilankastudyprotocolforaclusterrandomizedcontrolledtrial
AT clemensjohndavid multicomponentinterventionversususualcareformanagementofhypertensioninruralbangladeshpakistanandsrilankastudyprotocolforaclusterrandomizedcontrolledtrial
AT ebrahimshah multicomponentinterventionversususualcareformanagementofhypertensioninruralbangladeshpakistanandsrilankastudyprotocolforaclusterrandomizedcontrolledtrial
AT turnerelizabethl multicomponentinterventionversususualcareformanagementofhypertensioninruralbangladeshpakistanandsrilankastudyprotocolforaclusterrandomizedcontrolledtrial
AT multicomponentinterventionversususualcareformanagementofhypertensioninruralbangladeshpakistanandsrilankastudyprotocolforaclusterrandomizedcontrolledtrial
AT kasturiratneanuradhani multicomponentinterventionversususualcareformanagementofhypertensioninruralbangladeshpakistanandsrilankastudyprotocolforaclusterrandomizedcontrolledtrial