- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03481335
Community Health Assessment Program in the Philippines (CHAP-P) (CHAP-P)
Cluster Randomized Controlled Trial for a Community Health Promotion Program: Community Health Assessment Program in the Philippines (CHAP-P)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Zamboanga Del Sur
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Zamboanga City, Zamboanga Del Sur, Philippines, 7000
- Ateneo de Zamboanga University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Community
Intervention communities (barangays) will receive the intervention (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.
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No Intervention: Control Community
Control communities (barangays) will receive care as usual.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline, 6 months
|
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.
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Baseline, 6 months
|
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.
|
Baseline, 6 months
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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
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6 months
|
Hospital admission rates
Time Frame: -12 months, 12 months
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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)
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-12 months, 12 months
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Mortality rates
Time Frame: -12 months, 12 months
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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)
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-12 months, 12 months
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Quality of Life (EQ5D-5L)
Time Frame: Baseline, 6 months
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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
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Knowledge about Diabetes and Hypertension
Time Frame: Baseline, 6 Months
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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.
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Baseline, 6 Months
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Risk Factors for Diabetes
Time Frame: Baseline, 6 months
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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
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Baseline, 6 months
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Risk Behaviours for Diabetes/Cardiovascular Issues
Time Frame: Baseline, 6 months
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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.
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Baseline, 6 months
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Perceived Concern and Understanding of Risk
Time Frame: Baseline, 6 months
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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.
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Baseline, 6 months
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Confidence in Behaviour Change
Time Frame: Baseline, 6 months
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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
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Quality-Adjusted Life Years (QALYs)
Time Frame: 12 months
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Secondary; calculated from the EQ5D-5L.
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12 months
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Cost-effectiveness
Time Frame: 12 months
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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
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Cost-utility
Time Frame: 12 months
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Cost of program and healthcare resource utilization costs per QALY
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Fortunato Cristobal, MD, MPH, MHPEd, Ateneo de Zamboanga University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4303
- 231837 (Other Grant/Funding Number: CIHR)
- 107826-001 (Other Grant/Funding Number: IDRC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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