Clinical trial NCT06726057: Implementing a Multi-component Hypertension Control Strategy in Rural Pakistan
Official title: A Multi-component Intervention for Controlling Hypertension in the Adult Rural Population of Pakistan: a Protocol for a Hybrid Type III Implementation-effectiveness Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: University of York
First posted: 2024-12-10
Enrollment: 3000
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid type III implementation-effectiveness cluster randomized controlled trial
Primary purpose: PREVENTION

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 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).


Eligibility criteria: 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

Primary outcomes:
measure: BP-lowering medications per participant
timeFrame: From enrollment to the end of Intervention at 24 months
Secondary outcomes:
Other outcomes:
measure: Implementation outcomes [as per RE-AIM framework domain of Adoption ]
timeFrame: From enrollment to the first 12 months of Intervention
measure: Implementation outcomes [as per RE-AIM framework domain of Adoption ]
timeFrame: From enrollment to the first 12 months of Intervention
measure: Implementation outcomes [as per RE-AIM framework domain of Implementation]
timeFrame: From enrollment to the end of Intervention at 24 months
measure: Implementation outcomes [as per RE-AIM framework domain of Implementation]
timeFrame: From enrollment to the end of Intervention at 24 months
measure: Implementation outcomes [as per RE-AIM framework domain of Maintenance]
timeFrame: From enrollment to the end of Intervention at 24 months
measure: Implementation outcomes [as per RE-AIM framework domain of Maintenance]
timeFrame: From enrollment to the end of Intervention at 24 months
measure: Effectiveness outcomes
timeFrame: From enrollment to the end of Intervention at 24 months
measure: Effectiveness outcomes
timeFrame: From enrollment to the end of Intervention at 24 months
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
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