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

Hypertension Clinical Trial

— CHAP-P  

Official title:

Cluster Randomized Controlled Trial for a Community Health Promotion Program: Community Health Assessment Program in the Philippines (CHAP-P)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03481335
• Other study ID #: 4303
• Secondary ID: 231837107826-001
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5229
• Est. completion date: December 31, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Philippines	Ateneo de Zamboanga University	Zamboanga City	Zamboanga Del Sur

Sponsors (6)

Lead Sponsor	Collaborator
McMaster University	Ateneo de Zamboanga University, Canadian Institutes of Health Research (CIHR), Global Alliance for Chronic Diseases (GACD), International Development Research Centre, Canada, Université de Montréal

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	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.	Baseline, 6 months
Secondary	Physical Activity	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.	Baseline, 6 months
Secondary	Medication Compliance	Mean difference in medication compliance at 6 months in the intervention group compared to the control group. Self-reported, via community survey questions.	Baseline, 6 months
Secondary	Blood Pressure	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.	Baseline, 6 months
Secondary	Community Residents Newly Diagnosed with Diabetes	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	6 months
Secondary	Hospital admission rates	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)	-12 months, 12 months
Secondary	Mortality rates	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)	-12 months, 12 months
Secondary	Quality of Life (EQ5D-5L)	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	Baseline, 6 months
Secondary	Knowledge about Diabetes and Hypertension	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.	Baseline, 6 Months
Secondary	Risk Factors for Diabetes	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	Baseline, 6 months
Secondary	Risk Behaviours for Diabetes/Cardiovascular Issues	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.	Baseline, 6 months
Secondary	Perceived Concern and Understanding of Risk	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.	Baseline, 6 months
Secondary	Confidence in Behaviour Change	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.	Baseline, 6 months
Secondary	Quality-Adjusted Life Years (QALYs)	Secondary; calculated from the EQ5D-5L.	12 months
Secondary	Cost-effectiveness	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.	12 months
Secondary	Cost-utility	Cost of program and healthcare resource utilization costs per QALY	12 months