NCT06639412

Brief Summary

Background: Primary health care is an inclusive, equitable, cost-effective, and efficient approach to enhance the health of the community. Ethiopia has been implementing the primary healthcare approach for the last four decades. However, the performance of primary health care services in the country is not reaching the expected level, mainly in preventing non-communicable diseases. Objective: The aim of this study is to improve the performance of the primary healthcare system with a focus on preventing non-communicable diseases through the integrated efforts of parent-teachers association and agricultural extension workers with the health extension workers in West Gojjam Zone. Methods: A cluster randomized controlled community trial and a concurrent cross-sectional quantitative and qualitative approach will be used in this study. The study will be conducted in the West Gojjam Zone among 757 adults. A multistage sampling technique will be used. The intervention will be networking the indigenous parent-teacher association and agriculture development agents with the primary healthcare unit for enhancing non-communicable diseases prevention and control services. A structured interviewer-administered questionnaire will be used to collect quantitative data. Focus group discussions and key informant interviews will be conducted to collect qualitative data. Binary logistic regression analysis and Generalized Estimating Equation with a binary logit function will be computed. Thematic analysis will be used to analyze qualitative data. Work plan and budget: The project will be conducted from February 2023 to May 2024 using a total 10,000 US dollar. Benefits and beneficiaries: It will generate evidence on the contribution of networking institutions, community members, and the healthcare system to prevent and lower the burdens of major non-communicable diseases. Ministry of Health, Regional Health Bureaus, Zonal Health Departments, Woreda Health Offices, primary health care units, partners, and stockholders are potential beneficiaries of the project outputs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

March 13, 2024

Last Update Submit

September 16, 2025

Conditions

Keywords

non-communicable diseasesprimary health careParent-Teachers-Development Agents network

Outcome Measures

Primary Outcomes (2)

  • NCD care-seeking behavior of the community ( number of individuals who screened for NCD)

    NCD seeking service utilization of the community (checking blood pressure, blood glucose level, cervical cancer screening)

    nine months

  • knowledge on NCD

    improved knowledge of the community about NCD will be assessed using knowledge assessment questions.

    nine months

Secondary Outcomes (1)

  • Hypertension

    nine months

Study Arms (2)

Intervention arms

EXPERIMENTAL

The intervention arm will receive the intervention.The intervention will be networking the indigenous parent-teacher association and agriculture development agents with the PHC unit to enhance NCD prevention \& control services.

Behavioral: Networking the indigenous parent-teacher association and agriculture development agents with the PHC unit to enhance NCD prevention & control services.

Control arm

ACTIVE COMPARATOR

Control Arm is an arm to which the intervention will not be implemented. The community in the control arm will receive NCD prevention and control measures given through the health care system.

Other: Usual care

Interventions

The intervention will be networking the indigenous parent-teacher association and agriculture development agents with the PHC unit to enhance NCD prevention \& control services. In this major activity, the project team will establish the network by incorporating agricultural development agents and parents- teacher associations to the health post as foundational actors for educating the community on NCD prevention and control measures. We will implement tier system training to effectively create awareness on NCD and to enhance the NCD care-seeking behavior of the community.

Intervention arms

The community in the control group will get noncommunicable disease prevention and control measures given through the health care system.

Control arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult individuals residing in the kebele will be included in the study.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahir Dar University

Bahir Dar, Ethiopia

Location

Related Publications (1)

  • Demilew YM, Wassie GT, Guadie HA, Asemahagn MA, Anagaw TF, Alene GD, Kassie GM. The effect of health education on hypertension, diabetes mellitus, and cervical cancer screening service utilization among eligible adults in a district around Bahir Dar city, Ethiopia: a cluster randomized controlled community trial. BMC Public Health. 2025 Aug 12;25(1):2736. doi: 10.1186/s12889-025-23841-7.

Related Links

MeSH Terms

Conditions

Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Getu D Alene, PhD

    Bahir Dar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
outcome assessors will not informed about the intervention and the group to which the intervention is assigned to avoid social desirability bias
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A cluster randomized controlled community trial design will also be used to evaluate the effect of Parent-Teachers-Development Agents network.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 13, 2024

First Posted

October 15, 2024

Study Start

August 1, 2023

Primary Completion

September 20, 2024

Study Completion

November 20, 2024

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations