Implementing a Multi-component Hypertension Control Strategy in Rural Pakistan

Aga Khan University

Status: Enrolling

Conditions: Hypertension

Treatments: Behavioral: Multicomponent hypertension intervention; Behavioral: Imlementation strategies in conjunction with multicomponent hypertension intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06726057

2023-9084-26739

Details and patient eligibility

About

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 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).

Enrollment: 3,000 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥35 years

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
   • Are on antihypertensive medications

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,000 participants in 2 patient groups

Multicomponent hypertension intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Multicomponent hypertension intervention

Implementation strategies in conjunction with multicomponent hypertension intervention

Experimental group

Description:

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

Treatment:

Behavioral: Imlementation strategies in conjunction with multicomponent hypertension intervention