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

NCT ID: NCT03481335

Last Updated: 2021-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2 Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Community

Intervention communities (barangays) will receive the intervention (CHAP-P sessions).

Group Type EXPERIMENTAL

CHAP-P Sessions

Intervention Type OTHER

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.

Control Community

Control communities (barangays) will receive care as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged 40 years of age or older
* Resident of community


\- Must be a BHW or other LLO staff who is participating in the CHAP-P Intervention

Exclusion Criteria

* Under 40 years of age
* Resident of a different community
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ateneo de Zamboanga University

OTHER

Sponsor Role collaborator

Université de Montréal

OTHER

Sponsor Role collaborator

Global Alliance for Chronic Diseases (GACD)

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

International Development Research Centre, Canada

OTHER_GOV

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gina Agarwal, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Fortunato Cristobal, MD, MPH, MHPEd

Role: PRINCIPAL_INVESTIGATOR

Ateneo de Zamboanga University

Locations

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Ateneo de Zamboanga University

Zamboanga City, Zamboanga Del Sur, Philippines

Site Status

Countries

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Philippines

References

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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.

Reference Type DERIVED
PMID: 31159778 (View on PubMed)

Other Identifiers

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231837

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

107826-001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

4303

Identifier Type: -

Identifier Source: org_study_id

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