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临床试验/NCT06163859
NCT06163859已完成不适用

Female Community Health Volunteers Led Hypertension Prevention and Control in Nepal: An Implementation Study

Kathmandu University School of Medical Sciences1 个研究点 分布在 1 个国家目标入组 520 人开始时间: 2024年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
520
试验地点
1
主要终点
Reach

研究概览

简要总结

Brief Summary Hypertension is a major public health problem in Nepal, with substantial gaps in awareness, treatment, and control, particularly in rural and semi-urban settings. Nepal has adopted the WHO Package of Essential Non-Communicable Diseases (PEN) to strengthen facility-based hypertension care; however, persistent community- and system-level barriers limit its effectiveness.

This study evaluates a Female Community Health Volunteer (FCHV)-led, community-based hypertension prevention and control intervention in Namobuddha Municipality, Kavrepalanchowk District, Nepal. The study uses a hybrid type II effectiveness-implementation cluster randomized controlled trial design to assess both implementation outcomes and clinical effectiveness. Twelve public primary healthcare facilities are randomized (1:1) to intervention or routine care. Implementation outcomes are assessed using the RE-AIM framework (Reach, Effectiveness, Adoption, and Implementation). The primary effectiveness outcome is change in mean systolic blood pressure at three months. Secondary outcomes include diastolic blood pressure, hypertension control status, hypertension knowledge, dietary behavior, medication adherence, and body mass index. The intervention mobilizes trained FCHVs to deliver group-based blood pressure monitoring, structured health education, lifestyle counseling, medication adherence support, and referral linkages to primary healthcare facilities.

详细描述

Study design: The investigators will conduct a Hybrid type II effectiveness-implementation design focusing on implementation outcomes while also collecting effectiveness outcomes as they relate to the uptake or fidelity of the intervention. A mixed-method approach will be used. The investigators will conduct a cluster randomized controlled trial among 520 participants, clustered within 12 health facilities. Among the participants of the intervention arm, the investigators will collect quantitative data on adoption, implementation and reach. The investigators will conduct in-depth interviews with 8-16 patients, at least 2 FGDs with FCHVs and at least 4 Key Informant Interviews (KIIs) with health workers to understand implementation outcomes. The investigators will maintain qualitative tracking logs to document meetings with FCHVs and healthcare workers.

Study site: In partnership with the Ministry of Health and Population (MoHP), the World Health Organization (WHO), and the NCD Flagship Initiative, and with funding from the Norwegian government, Bagmati province has initiated the Hypertension care cascade model in the Kavrepalnchowk district. In this context, our research aims to support the model's objectives by monitoring treatment outcomes and control rates at every stage of care in the Kavre district. The study will involve 12 basic health facilities in Namobuddha municipalities of Kavrepalnchowk, where approximately 82 female community health volunteers (FCHVs) are actively engaged. The selection of the study district and municipalities was done in consultation with WHO Nepal and Nepal Health Research Council, taking into consideration national priorities, Norad priorities, and ongoing NCD care activities in the district.

Study Population: At the facility level, the investigators will include basic health facilities that have implemented PEN, excluding those who are not within the network of the Nepal government health system. At the patient level, inclusion criteria will be: i) 30-75 years old ii) have a high blood pressure of 130/80 mmHg, iii) are able to provide informed consent. Exclusion criteria will include: severe illness requiring bed-rest, and pregnant women due to their special health needs.

Intervention :

We propose a community-based hypertension intervention in Namobuddha Municipality, leveraging Female Community Health Volunteers (FCHVs) as frontline implementers. A total of 34 FCHVs will each form a group of 7-16 participants and conduct one-hour, bi-monthly sessions over three months. Sessions will include:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 30 -75 years old
  • have a high blood pressure of 130/80 mmHg or under hypertension medication
  • are able to provide informed consent.

排除标准

  • severe illness requiring bed rest, and
  • pregnant women, due to their special health needs.

研究组 & 干预措施

Intervention Group

Experimental

Female Community Health Volunteers (FHPC) implementation strategy

干预措施: Intervention Group (Behavioral)

Control Arm

No Intervention

Routine hypertension care

结局指标

主要结局

Reach

时间窗: 3 months

The proportion of the target population that participates in the intervention. Indicators: Proportion of individuals screened during one-day hypertension screening camps in each health facilities by FCHVs.( denomiator will be determined using national prevalence of hypertension). Data Source: Patient records maintained by FCHV, attendance sheets from FCHV-HTN group meetings. Demographic distribution (age, gender, etc.) of the individuals screened.

Adoption

时间窗: 3 months

Adoption is defined as the proportion of eligible health facilities that agreed to participate in the study. Participation will be confirmed through signed minutes from meetings between the municipal health coordinator and facility representatives, indicating formal approval to implement the program.

Implementation

时间窗: 3 months

The extent to which the FCHV-led intervention is delivered as intended. Indicators: Number of FCHVs conducting complete (3 months) FCHV-HTN meetings, Documentation and follow-up of participants' blood pressure logs by FCHVs, duration of sessions conducted, number of sessions conducted. Data source: Forms sent by FCHV at health facilities (compiled at Health facilities), logs maintained by FCHVs

Mean systolic blood pressure (BP) (mmHg)

时间窗: 3 months

The net change in mean systolic BP between intervention and control

次要结局

  • Mean diastolic BP (mmHg)(3 months)
  • Physical activity(3 months)
  • Fruits and vegetables intake(3 months)
  • Medication adherence(3 months)
  • Proportion controlling BP (<140/90 mmHg)(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Archana Shrestha

Professor

Kathmandu University School of Medical Sciences

研究点 (1)

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