Health Trials

FCHV-HTN Implementation Trial in Nepal

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorYale University

About this trial

The goal of this hybrid type III study incorporating a cluster-randomized trial is to assess the effect of a community health worker-led hypertension prevention and control program (CHPC) on the implementation outcomes and clinical outcomes among patient with hypertension in central Nepal. The main questions it aims to answer are:

1\. What is the level of implementation outcomes, including reach, adoption, implementation fidelity, and maintenance of the CHPC implementation strategy at the patient, provider, and health system levels?

2: What is the effectiveness of the CHPC implementation strategy compared to facility-based intervention on systolic BP via a cluster randomized controlled trial.

3: What is the implementation cost and cost-effectiveness of the CHPC implementation strategy?

Participants will receive four follow-up group meetings or home visits every three months for a year by a community health worker. Researchers will compare if there is a significant difference in systolic blood pressure between those who receive this intervention and those who do not receive the intervention in the same community.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Severe illness requiring bed rest

Pregnant women, due to their special health needs

Trial design

Design model

Parallel

Treatments tested in this trial

  • Community Health Worker Intervention

    Behavioral

    Trained CHWs will hold group meetings or home visits using a locally adapted manual for HTN management. CHWs will visit homes in their areas and measure BP. High BP clients will be taken to the nearest health center. CHWs will enroll individuals with preHTN and HTN and conduct 4 follow-up group meetings or home visits with them every 3 months. Participants will be invited to attend CHW lead group-based counseling. For those with uncontrolled HTN who have difficulty adhering to prescribed HTN management and not willing or able to attend group meetings, CHWs will conduct follow-up home visits. First meeting (about 90 minutes), CHWs will explain purpose of the meeting and discuss HTN and its consequences. CHWs will apply techniques to initiate dialogue and reflection regarding lifestyle modifications and choose goals based on PEN protocol-2, BP monitoring, and antihypertensive medication use. In subsequent meetings (about 60 minutes), the CHWs will measure BP and address ongoing problems.

Treatment groups

3,572 Participants
are divided into 2 treatment groups
Group A: Intervention armExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Reach

Percentage of CHWs implementing the program

Time frame
12 months
2

Adoption

Percentage of the health facilities asked to participate in adopting the program

Time frame
12 months
3

Program implementation

Percent of the health facility will implement a minimum standard to program implementation

Time frame
12 months
4

Maintenance

Percentage of the health facility that will implement a minimum standard to program implementation during the maintenance period

Time frame
24 months

Secondary outcomes

1

Blood Pressure

Difference in mean systolic and diastolic blood pressure (mmHg) between study arms

Time frame
12 months
2

Hypertension Diagnosis Awareness

Difference in proportion of patients aware of their HTN diagnosis between study arms

Time frame
12 months
3

Blood Pressure Control

Difference in proportion of patients with controlled BP (less than 140/90 mmHg) between study arms

Time frame
12 months
4

Physical activity

Proportion of patients with low physical activity (less than 600 MET-minutes per week) between study arms

Time frame
12 months

Other outcomes

Sponsors and contacts

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Yale University

Lead sponsor

Dhulikhel Hospital

Collaborator

Institute for Implementation Science and Health

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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