NCT03481335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,229

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

March 22, 2018

Last Update Submit

February 25, 2021

Conditions

Diabetes Mellitus, Type 2Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • Physical Activity

    Baseline, 6 months

  • Medication Compliance

    Baseline, 6 months

  • Blood Pressure

    Baseline, 6 months

  • Community Residents Newly Diagnosed with Diabetes

    6 months

  • Hospital admission rates

    -12 months, 12 months

  • +10 more secondary outcomes

Study Arms (2)

Intervention Community

EXPERIMENTAL

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

Other: CHAP-P Sessions

Control Community

NO INTERVENTION

Control communities (barangays) will receive care as usual.

Interventions

CHAP-P SessionsOTHER

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 Community

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Under 40 years of age
  • Resident of a different community
  • \- Must be a BHW or other LLO staff who is participating in the CHAP-P Intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ateneo de Zamboanga University

Zamboanga City, Zamboanga Del Sur, 7000, Philippines

Location

Related Publications (1)

  • 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.

    PMID: 31159778DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypertension

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gina Agarwal, MBBS, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Fortunato Cristobal, MD, MPH, MHPEd

    Ateneo de Zamboanga University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2018

First Posted

March 29, 2018

Study Start

June 1, 2018

Primary Completion

July 1, 2019

Study Completion

December 31, 2020

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

PH(1)