Clinical trial NCT03481335: Community Health Assessment Program in the Philippines (CHAP-P)
Official title: Cluster Randomized Controlled Trial for a Community Health Promotion Program: Community Health Assessment Program in the Philippines (CHAP-P)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypertension
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Ateneo de Zamboanga University
name: Université de Montréal
name: Global Alliance for Chronic Diseases (GACD)
name: Canadian Institutes of Health Research (CIHR)
name: International Development Research Centre, Canada
First posted: 2018-03-29
Enrollment: 5229
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a parallel 26-community cluster randomized controlled trial. A community cluster design was chosen as CHAP-P is intended as a community-level intervention. Thirteen communities (barangays) will receive the CHAP-P sessions and will be considered intervention, while the other 13 communities will receive care as usual and will be considered control. Measures of individual participants will be taken as a repeated cross-sectional sample at baseline and at six months. A community process evaluation and cost-effectiveness evaluation will also be undertaken.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Physical Activity
timeFrame: Baseline, 6 months
measure: Medication Compliance
timeFrame: Baseline, 6 months
measure: Blood Pressure
timeFrame: Baseline, 6 months
measure: Community Residents Newly Diagnosed with Diabetes
timeFrame: 6 months
measure: Hospital admission rates
timeFrame: -12 months, 12 months
measure: Mortality rates
timeFrame: -12 months, 12 months
measure: Quality of Life (EQ5D-5L)
timeFrame: Baseline, 6 months
measure: Knowledge about Diabetes and Hypertension
timeFrame: Baseline, 6 Months
measure: Risk Factors for Diabetes
timeFrame: Baseline, 6 months
measure: Risk Behaviours for Diabetes/Cardiovascular Issues
timeFrame: Baseline, 6 months
measure: Perceived Concern and Understanding of Risk
timeFrame: Baseline, 6 months
measure: Confidence in Behaviour Change
timeFrame: Baseline, 6 months
measure: Quality-Adjusted Life Years (QALYs)
timeFrame: 12 months
measure: Cost-effectiveness
timeFrame: 12 months
measure: Cost-utility
timeFrame: 12 months
Other outcomes:
Locations:
city: Zamboanga City
country: Philippines
facility: Ateneo de Zamboanga University
state: Zamboanga Del Sur
Study officials:
affiliation: McMaster University
name: Gina Agarwal, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ateneo de Zamboanga University
name: Fortunato Cristobal, MD, MPH, MHPEd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agarwal G, Angeles RN, Dolovich L, Kaczorowski J, Gaber J, Guenter D, Arnuco FD, Lam HY, Thabane L, O'Reilly D, Agbulos RM, Arciaga RS, Barrera J, Gregorio E, Halili S Jr, Jalani N, Cristobal F. The Community Health Assessment Program in the Philippines (CHAP-P) diabetes health promotion program for low- to middle-income countries: study protocol for a cluster randomized controlled trial. BMC Public Health. 2019 Jun 3;19(1):682. doi: 10.1186/s12889-019-6974-z.