Community Health Assessment Program in the Philippines (CHAP-P)

Not Applicable

Completed

• Conditions: Hypertension; Diabetes Mellitus, Type 2
• Interventions: Other: CHAP-P Sessions

• Registration Number: NCT03481335
• Lead Sponsor: McMaster University

Brief Summary

This study aims to evaluate the effectiveness of the Community Health Assessment Program in the Philippines (CHAP-P), looking at the differences between communities implementing CHAP-P versus communities not implementing CHAP-P.

Detailed Description

In this study, the investigators are evaluating the effectiveness of the CHAP-P intervention in communities of the Zamboanga Peninsula, Philippines. Specifically, the investigators are looking at the difference between hemoglobin A1c (HbA1c) levels in randomly selected residents of control communities versus those in communities implementing the CHAP-P intervention. The investigators are also looking at the differences between control and intervention communities in modifiable lifestyle risk factors for diabetes, screening rates for diabetes, rates of newly diagnosed cases of diabetes, general diabetes management, and hospital admission rates, as well as the cost effectiveness of CHAP-P.

The CHAP-P intervention consists of initial and follow-up sessions where trained local volunteers (Barangay Health Workers, or BHWs) take physical measurements (blood pressure, height, weight, waist circumference) and facilitate a diabetes risk survey; based on these findings, they provide education, materials, and referrals to local health resources as needed.

The participant groups in this evaluation include those that attend CHAP-P sessions, randomly selected community members that provide consent for a survey and HbA1c testing, and community members and BHWs/other Lead Local Organization staff who provide consent for focus groups and interviews.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-29
• Study Start: 2018-06-01
• Primary Completion: 2019-07-01
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5229

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Community	CHAP-P Sessions	Intervention communities (barangays) will receive the intervention (CHAP-P sessions).

Primary Outcome Measures

Name	Time	Method
HbA1c	Baseline, 6 months	Mean difference in HbA1c at 6 months in the intervention group compared to the control group. Measured with the A1CNow+ point-of-care device in a community location after the completion of the in-home community survey.

Secondary Outcome Measures

Name	Time	Method
Cost-utility	12 months	Cost of program and healthcare resource utilization costs per QALY
Physical Activity	Baseline, 6 months	Mean difference in physical activity at 6 months in the intervention group compared to the control group. Measured with the International Physical Activity Questionnaire (International Physical Activity Quotient, IPAQ), included in the community survey.
Medication Compliance	Baseline, 6 months	Mean difference in medication compliance at 6 months in the intervention group compared to the control group. Self-reported, via community survey questions.
Hospital admission rates	-12 months, 12 months	Mean difference in hospital admission rates due to diabetes and diabetes-related conditions, hypertension, myocardial infarction, stroke, congestive heart failure at 6 months in the intervention group compared to the control group. Numbers taken from central Department of Health database (12 months before and 12 month after CHAP-P implementation, and divided by mid-year population estimates)
Confidence in Behaviour Change	Baseline, 6 months	Mean difference in confidence in behaviour change at 6 months in the intervention group compared to the control group. Measured with elements of the Health Awareness and Behaviour Tool (HABiT) included in the community survey.
Blood Pressure	Baseline, 6 months	Mean difference in blood pressure at 6 months in the intervention group compared to the control group. Measured using a blood pressure device, the Microlife WatchBP Office Target.
Community Residents Newly Diagnosed with Diabetes	6 months	Mean difference in number of community residents newly diagnosed with diabetes at 6 months in the intervention group compared to the control group. Numbers taken from Rural Health Unit databases
Knowledge about Diabetes and Hypertension	Baseline, 6 Months	Mean difference in knowledge about diabetes and hypertension at 6 months in the intervention group compared to the control group. Measured with elements of the Health Awareness and Behaviour Tool (HABiT) included in the community survey.
Risk Behaviours for Diabetes/Cardiovascular Issues	Baseline, 6 months	Mean difference in risk behavhiours for diabetes/cardiovascular issues (activity, diet, smoking, alcohol, stress) at 6 months in the intervention group compared to the control group. Measured with elements of the Health Awareness and Behaviour Tool (HABiT) included in the community survey.
Quality-Adjusted Life Years (QALYs)	12 months	Secondary; calculated from the EQ5D-5L.
Quality of Life (EQ5D-5L)	Baseline, 6 months	Mean difference in quality of life at 6 months in the intervention group compared to the control group. Measured with the EuroQol-5 dimension-5 level (EQ5D-5L), included in the community survey
Cost-effectiveness	12 months	Comparing program cost of implementing CHAP-P (collected via team tracking) and healthcare resource utilization costs (collected via self-report from participants during community survey) to percentage reduction in HbA1c and blood pressure.
Mortality rates	-12 months, 12 months	Mean difference in mortality rates due to diabetes and diabetes-related conditions, hypertension, myocardial infarction, stroke, congestive heart failure based on International Classification of Disease (ICD)-10 codes at 6 months in the intervention group compared to the control group. Numbers taken from Regional Field Health Surveillance Information Systems (measured 12 months before and 12 month after CHAP-P implementation, 6 month estimated by dividing by mid-year population estimates)
Risk Factors for Diabetes	Baseline, 6 months	Mean difference in risk factors for diabetes at 6 months in the intervention group compared to the control group. Measured with the Finnish Diabetes Risk Score (FINDRISC), included in the community survey
Perceived Concern and Understanding of Risk	Baseline, 6 months	Mean difference in perceived concern and understanding of risk at 6 months in the intervention group compared to the control group. Measured with elements of the Health Awareness and Behaviour Tool (HABiT) included in the community survey.

Trial Locations

Locations (1)

Ateneo de Zamboanga University; 🇵🇭 Zamboanga City, Zamboanga Del Sur, Philippines