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

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ClinicalTrials.gov Identifier: NCT03481335
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : August 17, 2018
Sponsor:
Collaborators:
Ateneo de Zamboanga University
Université de Montréal
Global Alliance for Chronic Diseases (GACD)
Canadian Institutes of Health Research (CIHR)
International Development Research Centre, Canada
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Hypertension Other: CHAP-P Sessions Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cluster Randomized Controlled Trial for a Community Health Promotion Program: Community Health Assessment Program in the Philippines (CHAP-P)
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Community
Intervention communities (barangays) will receive the intervention (CHAP-P sessions).
Other: 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.

No Intervention: Control Community
Control communities (barangays) will receive care as usual.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481335


Contacts
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Contact: Jessica Gaber, MSW 905-521-2100 ext 28493 jgaber@mcmaster.ca
Contact: Ricardo Angeles, MD, MPH, MHPEd, PhD 905-521-2100 ext 21203 angelesric@gmail.com

Locations
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Philippines
Ateneo de Zamboanga University Recruiting
Zamboanga City, Zamboanga Del Sur, Philippines, 7000
Contact: Floro Dave Arnuco, MD         
Sponsors and Collaborators
McMaster University
Ateneo de Zamboanga University
Université de Montréal
Global Alliance for Chronic Diseases (GACD)
Canadian Institutes of Health Research (CIHR)
International Development Research Centre, Canada
Investigators
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Principal Investigator: Gina Agarwal, MBBS, PhD McMaster University
Principal Investigator: Fortunato Cristobal, MD, MPH, MHPEd Ateneo de Zamboanga University

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03481335     History of Changes
Other Study ID Numbers: 4303
231837 ( Other Grant/Funding Number: CIHR )
107826-001 ( Other Grant/Funding Number: IDRC )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases