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

Overview

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.

Full Title of Study: “Cluster Randomized Controlled Trial for a Community Health Promotion Program: Community Health Assessment Program in the Philippines (CHAP-P)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2019

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.

Interventions

  • Other: CHAP-P Sessions
    • Residents of intervention communities (barangays) aged 40+ are openly invited to attend CHAP-P sessions. At CHAP-P sessions, trained local volunteers (Barangay Health Workers, or BHWs) collect consent, measure blood pressure, collect other physical measurements, and conduct a survey to determine clients’ risk of diabetes. Based on the findings, BHWs provide education and/or referrals. CHAP-P sessions are held twice a month, and clients are encouraged to continuing attending for ongoing follow-up and monitoring.

Arms, Groups and Cohorts

  • Experimental: Intervention Community
    • Intervention communities (barangays) will receive the intervention (CHAP-P sessions).
  • No Intervention: Control Community
    • Control communities (barangays) will receive care as usual.

Clinical Trial Outcome Measures

Primary Measures

  • HbA1c
    • Time Frame: 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 Measures

  • Physical Activity
    • Time Frame: 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
    • Time Frame: 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.
  • Blood Pressure
    • Time Frame: 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
    • Time Frame: 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
  • Hospital admission rates
    • Time Frame: -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)
  • Mortality rates
    • Time Frame: -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)
  • Quality of Life (EQ5D-5L)
    • Time Frame: 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
  • Knowledge about Diabetes and Hypertension
    • Time Frame: 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 Factors for Diabetes
    • Time Frame: 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
  • Risk Behaviours for Diabetes/Cardiovascular Issues
    • Time Frame: 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.
  • Perceived Concern and Understanding of Risk
    • Time Frame: 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.
  • Confidence in Behaviour Change
    • Time Frame: 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.
  • Quality-Adjusted Life Years (QALYs)
    • Time Frame: 12 months
    • Secondary; calculated from the EQ5D-5L.
  • Cost-effectiveness
    • Time Frame: 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.
  • Cost-utility
    • Time Frame: 12 months
    • Cost of program and healthcare resource utilization costs per QALY

Participating in This Clinical Trial

Inclusion Criteria (Community Survey Participants & CHAP-P Session Participants):

  • Aged 40 years of age or older – Resident of community Exclusion Criteria (Community Survey Participants & CHAP-P Session Participants): – Under 40 years of age – Resident of a different community Inclusion Criteria (Barangay Health Workers [BHW]/Lead Local Organization [LLO] Staff) – Must be a BHW or other LLO staff who is participating in the CHAP-P Intervention

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • McMaster University
  • Collaborator
    • Ateneo de Zamboanga University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gina Agarwal, MBBS, PhD, Principal Investigator, McMaster University
    • Fortunato Cristobal, MD, MPH, MHPEd, Principal Investigator, Ateneo de Zamboanga University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.