Implementing a Multi-component Hypertension Control Strategy in Rural Pakistan

NCT06726057 | Active Not Recruiting DMC

• 1 other identifier: 2023-9084-26739
• Study Type: interventional
• Target: 3,459
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research about cardiovascular disease risk reduction: a comprehensive package for the reduction of risk in Sindh, Pakistan. The research is being conducted by the Aga Khan University and is funded by the National Institute of Health and Care Research UK. 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 2.5 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 2.5 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).

Conditions

Hypertension

Keywords

multicomponent hypertension intervention; rural PAkistan; primary care setting; basic health unit; lady health workers; community health workers; hypertension in rural adult population; health education; blood pressure monitoring by community health workers; referrals; hypertension management; implementation trial; hybrid type III trial; implementation effectiveness trial; cluster randomized controlled trial; trial on hypertension; CFIR; ERIC; consolidated framework for implementation research; expert recommendations for implementation change; general practitioners; doctors; control of blood pressure; community based intervention for control of hypertension

Outcome Measures

Primary Outcomes (1)

• Change in BP-lowering medications per participant

  Primary outcome will be the change in BP-lowering medications per participant from baseline to end line

  From enrollment to the end of Intervention at 24 months

Other Outcomes (8)

• Implementation outcomes [as per RE-AIM framework domain of Adoption ]

  From enrollment to the first 12 months of Intervention

• Implementation outcomes [as per RE-AIM framework domain of Adoption ]

  From enrollment to the first 12 months of Intervention

• Implementation outcomes [as per RE-AIM framework domain of Implementation]

  From enrollment to the end of Intervention at 24 months

Study Arms (2)

Multicomponent hypertension intervention

ACTIVE COMPARATOR

The multicomponent hypertension intervention arm (control arm) will receive the proven multicomponent hypertension intervention (MCHI) comprising four components.

Behavioral: Multicomponent hypertension intervention

Implementation strategies in conjunction with multicomponent hypertension intervention

EXPERIMENTAL

Implementation strategies in conjunction with multicomponent hypertension intervention arm (Intervention arm) will receive implementation strategies in conjunction with multi-component hypertension intervention (MCHI)

Behavioral: Imlementation strategies in conjunction with multicomponent hypertension intervention

Interventions

Imlementation strategies in conjunction with multicomponent hypertension intervention BEHAVIORAL

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.

Implementation strategies in conjunction with multicomponent hypertension intervention

Multicomponent hypertension intervention BEHAVIORAL

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.

Multicomponent hypertension intervention

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥35 years
• Residents of the selected clusters
• 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.

You may not qualify if:

• Pregnant women and persons with advanced illness (e.g., those receiving dialysis or with liver failure), cancer
• Unable to travel to the clinic
• Unwilling/unable to provide consent

Sponsors & Collaborators

• Aga Khan University: lead
• University of York: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (1)

• Naeem I, Almas A, Sheikh A, Hewitt C, Khwaja H, Afaq S, Bukhari S, Soofi S, S Virani S, Hanif S, Hashmi S, Walker S, Bhutta ZA, Siddiqi K, Samad Z. Multicomponent intervention for controlling hypertension in the adult rural population of Pakistan: a protocol for a hybrid type III implementation-effectiveness cluster randomised controlled trial. BMJ Open. 2025 Jun 27;15(6):e100365. doi: 10.1136/bmjopen-2025-100365.

  PMID: 40578881 BACKGROUND

MeSH Terms

Conditions

Hypertension; Health Education

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Hybrid type III implementation-effectiveness cluster randomized controlled trial

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: December 10, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)