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Completed

NCT Number: NCT03481335

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ateneo de Zamboanga University

Zamboanga City, Zamboanga Del Sur, 7000, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHAP-P Sessions

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. Hospital admission rates

    Time frame: -12 months, 12 months

    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)

  6. Mortality rates

    Time frame: -12 months, 12 months

    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)

  7. Quality of Life (EQ5D-5L)

    Time frame: Baseline, 6 months

    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

  8. Knowledge about Diabetes and Hypertension

    Time frame: Baseline, 6 Months

    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.

  9. Risk Factors for Diabetes

    Time frame: Baseline, 6 months

    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

  10. Risk Behaviours for Diabetes/Cardiovascular Issues

    Time frame: Baseline, 6 months

    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.

  11. Perceived Concern and Understanding of Risk

    Time frame: Baseline, 6 months

    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.

  12. Confidence in Behaviour Change

    Time frame: Baseline, 6 months

    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.

  13. Quality-Adjusted Life Years (QALYs)

    Time frame: 12 months

    Secondary; calculated from the EQ5D-5L.

  14. Cost-effectiveness

    Time frame: 12 months

    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.

  15. Cost-utility

    Time frame: 12 months

    Cost of program and healthcare resource utilization costs per QALY

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CHAP-P

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Mar 29, 2018
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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