Implementing a Multi-component Hypertension Control Strategy in Rural Pakistan
NCT ID: NCT06726057
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
3476 participants
INTERVENTIONAL
2024-12-01
2027-12-31
Brief Summary
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Hypertension is a major public health concern globally. It is a significant risk for cardiovascular disease (CVD) and premature death. In Pakistan, the prevalence of hypertension, including those on medication, is high. However, there are also high rates of undertreatment and underdiagnosis of hypertension in Pakistan. Addressing the prevention and control of CVD requires a multi-faceted approach that targets diverse populations across different settings. In some populations, we have interventions that have been proven effective but have not been implemented for example in rural communities. In Pakistan, prior community-based trial regarding multi-component hypertension intervention has proven to be effective in reducing blood pressure. However, the findings of this work have not translated to change in practice on the ground suggesting the need for implementation research to examine the best ways to implement this intervention in the real world. Hence, in this study researchers aim to assess the impact of this evidence-based intervention when implemented at scale in rural communities.
Participants will be asked to participate in a research study designed to improve their blood pressure control. This study enrols participants aged 35 years and above. As part of this study, they will undergo:
* blood pressure measurements at regular intervals by lady health workers
* home health education sessions conducted by lady health workers
* participants may be referred to a nearby health facility/qualified medical practitioners for management of high blood pressure
* baseline survey at the start of the study having questions about participants' medical history, risk factors for cardiovascular disease and high blood pressure and bodily measurements including weight, height and waist circumference
* follow-up surveys every 6 months for 2 years. The survey questions will comprise of medical history, risk factors for cardiovascular disease and high blood pressure; and bodily measurements including weight, height and waist circumference
* blood and urine samples for testing at baseline survey and during endline survey
POSSIBLE RISKS OR DISCOMFORT
There are no risks involved as a result of participants' participation in this study except for their time. Since they will be followed up for 2 years, any new information developed during the study that may affect their willingness to continue participation will be communicated to them. Participants may feel a little discomfort at the site of the needle prick when drawing a blood sample.
POSSIBLE BENEFITS
Participants will be able to know about their risk of high blood pressure and cardiovascular disease. They'll be referred to a qualified medical practitioner for the management of your high blood pressure. Also, the results of their blood and urine tests will be shared with participants that will help them know about their health.
The main contact for this research study is the principal investigator Dr Zainab Samad (02134864660).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Multicomponent hypertension intervention
The multicomponent hypertension intervention arm (control arm) will receive the proven multicomponent hypertension intervention (MCHI) comprising four components.
Multicomponent hypertension intervention
The multicomponent hypertension intervention has four components as follows:
1. Training of community health workers (CHWs) in conducting health education sessions regarding hypertension, its risk factors, prevention, and health-seeking
2. Blood pressure (BP) monitoring and referral of hypertensive individuals by CHWs to general practitioners in primary care facilities
3. Training of general practitioners in primary care settings in BP monitoring and management of hypertension
4. Hypertension care coordination in primary care facilities for the care of referred patients.
Implementation strategies in conjunction with multicomponent hypertension intervention
Implementation strategies in conjunction with multicomponent hypertension intervention arm (Intervention arm) will receive implementation strategies in conjunction with multi-component hypertension intervention (MCHI)
Imlementation strategies in conjunction with multicomponent hypertension intervention
In this study, the researchers will develop and test strategies for the implementation and scale-up of a proven multicomponent hypertension intervention (MCHI) programme in Pakistan. Implementation strategies will be devised through an engagement process and will involve the use of implementation frameworks including the Consolidated Framework for Implementation Research (CFIR) to identify barriers and facilitators to the implementation of MCHI\& Expert Recommendations for Implementation Change (ERIC) to identify a set of implementation strategies addressing each barrier. Input for the development of strategies will be sought from the community, public health sector managers, general practitioners and community health workers. The implementation strategies will be used to randomise study clusters while MCHI will be implemented in both intervention and control arms.
Interventions
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Imlementation strategies in conjunction with multicomponent hypertension intervention
In this study, the researchers will develop and test strategies for the implementation and scale-up of a proven multicomponent hypertension intervention (MCHI) programme in Pakistan. Implementation strategies will be devised through an engagement process and will involve the use of implementation frameworks including the Consolidated Framework for Implementation Research (CFIR) to identify barriers and facilitators to the implementation of MCHI\& Expert Recommendations for Implementation Change (ERIC) to identify a set of implementation strategies addressing each barrier. Input for the development of strategies will be sought from the community, public health sector managers, general practitioners and community health workers. The implementation strategies will be used to randomise study clusters while MCHI will be implemented in both intervention and control arms.
Multicomponent hypertension intervention
The multicomponent hypertension intervention has four components as follows:
1. Training of community health workers (CHWs) in conducting health education sessions regarding hypertension, its risk factors, prevention, and health-seeking
2. Blood pressure (BP) monitoring and referral of hypertensive individuals by CHWs to general practitioners in primary care facilities
3. Training of general practitioners in primary care settings in BP monitoring and management of hypertension
4. Hypertension care coordination in primary care facilities for the care of referred patients.
Eligibility Criteria
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Inclusion Criteria
2. Residents of the selected clusters
3. Have hypertension defined as either:
* Persistently elevated BP (Systolic blood pressure \[SBP\] SBP ≥140 mm Hg or diastolic blood pressure \[DBP\] DBP ≥90 mm Hg) from each set of the last two of the three readings from two separate days, where BP measurements on the same day were measured at least 1 minute apart OR
* Diagnosed previously by a physician as hypertensive and/or on antihypertensive medications.
Exclusion Criteria
2. Unable to travel to the clinic
3. Unwilling/unable to provide consent
35 Years
ALL
No
Sponsors
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University of York
OTHER
Aga Khan University
OTHER
Responsible Party
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Zainab Samad
Professor
Locations
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Aga Khan University
Karachi, Sindh, Pakistan
Countries
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References
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Riaz M, Shah G, Asif M, Shah A, Adhikari K, Abu-Shaheen A. Factors associated with hypertension in Pakistan: A systematic review and meta-analysis. PLoS One. 2021 Jan 29;16(1):e0246085. doi: 10.1371/journal.pone.0246085. eCollection 2021.
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Waltz TJ, Powell BJ, Fernandez ME, Abadie B, Damschroder LJ. Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions. Implement Sci. 2019 Apr 29;14(1):42. doi: 10.1186/s13012-019-0892-4.
Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: 5. CVD Study Protocol V5 08112025 CT 1.4
Document Type: Study Protocol and Statistical Analysis Plan: CVD Study Protocol V1.2
Document Type: Study Protocol and Statistical Analysis Plan: CVD Study Protocol V1.1
Document Type: Study Protocol and Statistical Analysis Plan: CVD Study Protocol V1.3
Document Type: Informed Consent Form: Informed consent baseline recruitment
Document Type: Informed Consent Form: Informed consent workshop participants
Document Type: Informed Consent Form: Informed consent Screening
Related Links
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Provisional summary results of 6th population and housing census-2017. Matiari district
Updated CFIR Constructs
Use of Iterative PRISM and RE-AIM During Implementation
Other Identifiers
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2023-9084-26739
Identifier Type: -
Identifier Source: org_study_id
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