Clinical trial NCT06081010: FCHV-HTN Implementation Trial in Nepal
Official title: Community Health Worker Led Hypertension Prevention and Control (CHPC) in Nepal: An Implementation Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Community Health Worker
Implementation Trial
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Dhulikhel Hospital
name: Institute for Implementation Science and Health
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-10-12
Enrollment: 3572
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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 counseling and blood pressure monitoring services at their home every four 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.

Detailed description: INTRODUCTION:

Hypertension (HTN) is a global public health challenge. About 13.5% of global total mortality is attributed to high blood pressure (BP) worldwide. In addition, about 54% of strokes and 47% of coronary heart disease worldwide were attributable to high BP. In Nepal, the adult HTN prevalence is 25%, similar to the global prevalence. Community Health Workers (CHWs) are the frontline pillars of community-based health programs in Nepal. Through CHW, this investigation aims to influence HTN control and behavior change among adults and society at large. By providing a replicable model for increasing HTN awareness, treatment, and control in Nepal, investigators will accelerate the integration of effective intervention into practice, providing an example of amelioration of the well-documented delays in moving tested interventions to practice. To ensure relevance to policymakers, the investigators will follow the principles of 'practical trials that include: (a) implementing the strategy, (b) facilitating and evaluating the maintenance of the strategy beyond the implementation phase; (c) using multiple evaluation measures relevant to decision makers, including reach, adoption, and cost; and (d) evaluating effectiveness across multiple outcomes, with a plan to triangulate findings from across multiple data sources using both qualitative and quantitative measures.

METHODS:

Investigators will conduct a Hybrid type III effectiveness-implementation design focusing primarily on implementation outcomes while also collecting effectiveness outcomes as they relate to the uptake or fidelity of the intervention. The primary implementation outcomes (aim 1) - reach, adoption, implementation and maintenance - are selected to answer the central research question of this study and will be assessed using a non-inferiority design. Investigators will assess these outcomes in the intervention group using data from the process evaluation in intervention health facilities. For each outcome, the null hypothesis is that the percentages are equivalent to a set target or greater. Thus, if the program is successful, investigators will be able to say with 95% confidence that these high standards have been met. To measure the effectiveness (aim 2), investigators will use a cluster-randomized design to assess change in mean systolic BP in the intervention group compared to the control group at 12 months after the intervention. Investigators will also measure cost and estimate incremental cost per participant with awareness on and control of high BP (aim 3).

STUDY SETTING:

We will conduct the study in Sindhupalchowk district, one of the largest districts in Bagmati province, Nepal, consisting of nine rural and three urban municipalities. Basic health facilities in the Sindhupalchowk district province that host CHWs will be included. In the study districts, there are 94 basic health facilities, and approximately 846 CHWs. These CHWs are female community health volunteers (FCHV) who provide basic health services in Nepal, historically focused on maternal and child health.

INTERVENTION: FCHV-led Hypertension Prevention and Control (CHPC) Program

Fundamentally, the intervention involves task-shifting of HTN management roles to primary care and community-level health workers, integrating the five components of the evidence-based interventions outlined in the Package of Essential Non-Communicable Diseases (PEN) protocol 1 and 2:

1. BP measurement and monitoring;
2. identify high BP individuals and report to health facility;
3. provide one-on-one counseling and lifestyle modification goal setting including sodium reduction, healthy diet, alcohol abstinence, physical activity, and medication;
4. BP monitoring of HTN patients; and
5. medication adherence of HTN patients, delivered by the FCHVs trained for the intervention.

The intervention will be conducted over a fiscal year, and repeated during the maintenance.

IMPLEMENTATION STRATEGIES:

To address barriers of implementing the intervention, we will incorporate the following strategies and core components:

1. Leadership support and ongoing program promotion - Health Coordinators from Provincial MoH will participate in the planning, execution and monitoring of the study. In provincial MoH health review meetings, hypertension-related indicators (proportion of population screened, HTN detected, HTN under medication, HTN control) will be discussed using the government's health management information system data.
2. Capacity building - Healthcare workers training; FCHV training; Coaching and technical support from healthcare workers to FCHV in a monthly meeting
3. CHW home visit and group meeting - 1st visit: introduction, rapport building, goal setting, BP monitoring; 2nd- 4th visit: BP monitoring, action and reflection, discussing problems faced in achieving their goals and implementing their action plans
4. Social network - Monthly meeting of health care workers in the municipality; Monthly meeting of FCHVs in the health facility

DATA SOURCES:

Quantitative - Participant Survey; Anthropometric Measurement; Blood Pressure Measurement; Healthcare Provider Survey; Process Tracking

Qualitative - Periodic Reflection; Meeting Observations; Focus Group Discussions; Key Informant Interviews

The primary aim is to determine the extent to which this implementation model meets acceptable rates of program adoption, implementation, reach and maintenance of the CHPC program. For assessing the adoption, implementation, reach, and maintenance, we will include all intervention health facilities. To assess the effectiveness, we are planning for patients to be enrolled over six months.

Eligibility criteria: Inclusion Criteria:

-High blood pressure (BP) of 140/90 mmHg or higher.

Exclusion Criteria:

* Severe illness requiring bed rest
* Pregnant women, due to their special health needs

Primary outcomes:
measure: Reach
timeFrame: 12 months
measure: Adoption
timeFrame: 12 months
measure: Program implementation
timeFrame: 12 months
measure: Maintenance
timeFrame: 24 months
Secondary outcomes:
measure: Blood Pressure
timeFrame: 12 months
measure: Hypertension Diagnosis Awareness
timeFrame: 12 months
measure: Blood Pressure Control
timeFrame: 12 months
measure: Physical activity
timeFrame: 12 months
measure: Fruits and Vegetables
timeFrame: 12 months
measure: Medication
timeFrame: 12 months
measure: Affordability
timeFrame: 12 months
measure: Equity
timeFrame: 12 months
measure: Scalability
timeFrame: 12 months
measure: Cost-effectiveness
timeFrame: 12 months
measure: Cost-effectiveness
timeFrame: 12 months
measure: Scalability
timeFrame: 12 months
Other outcomes:
Locations:
city: Dhulikhel
country: Nepal
facility: Dhulikhel Hospital
Study officials:
affiliation: Yale University
name: Donna Spiegelman, ScD
role: PRINCIPAL_INVESTIGATOR
References: