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Diabetes Mellitus, Type 2CHAP-PNCT03481335

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

A study testing CHAP-P Sessions in people with Diabetes Mellitus, Type 2 and Hypertension, run by McMaster University at 1 site in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2, Hypertension
What is being tested?
CHAP-P Sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,229 participants
Where
1 sitePhilippines
Study dates
1 Jun 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Philippines1 site

  • Ateneo de Zamboanga University

    Zamboanga City, Zamboanga Del Sur, 7000

Other trials in Philippines

About this study

Official title: Cluster Randomized Controlled Trial for a Community Health Promotion Program: 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.

Read the 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.

Being tested
CHAP-P Sessions
Medical subject headings
Diabetes Mellitus, Type 2, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03481335
Study groupRoleWhat they receive
Intervention CommunityExperimentalIntervention communities (barangays) will receive the intervention (CHAP-P sessions).
Receives: Other: CHAP-P Sessions
Control CommunityNo interventionControl communities (barangays) will receive care as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 6 months

Secondary outcomes (15)

  1. Physical Activity

    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.

    Measured: Baseline, 6 months

  2. Medication Compliance

    Mean difference in medication compliance at 6 months in the intervention group compared to the control group. Self-reported, via community survey questions.

    Measured: Baseline, 6 months

  3. Blood Pressure

    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.

    Measured: Baseline, 6 months

  4. Community Residents Newly Diagnosed with Diabetes

    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

    Measured: 6 months

  5. Hospital admission rates

    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)

    Measured: -12 months, 12 months

  6. Mortality rates

    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)

    Measured: -12 months, 12 months

  7. Quality of Life (EQ5D-5L)

    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

    Measured: Baseline, 6 months

  8. Knowledge about Diabetes and Hypertension

    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.

    Measured: Baseline, 6 Months

  9. Risk Factors for Diabetes

    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

    Measured: Baseline, 6 months

  10. Risk Behaviours for Diabetes/Cardiovascular Issues

    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.

    Measured: Baseline, 6 months

  11. Perceived Concern and Understanding of Risk

    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.

    Measured: Baseline, 6 months

  12. Confidence in Behaviour Change

    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.

    Measured: Baseline, 6 months

  13. Quality-Adjusted Life Years (QALYs)

    Secondary; calculated from the EQ5D-5L.

    Measured: 12 months

  14. Cost-effectiveness

    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.

    Measured: 12 months

  15. Cost-utility

    Cost of program and healthcare resource utilization costs per QALY

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2018
  2. Study start1 Jun 2018
  3. Primary completion1 Jul 2019
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
5,229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03481335
Sponsor's protocol ID
4303
Other IDs
231837, 107826-001
Acronym
CHAP-P
Status last verified
Feb 2021
First submitted
22 Mar 2018
Last updated
1 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31159778

Questions about this trial

What is this clinical trial studying?

A study testing CHAP-P Sessions in people with Diabetes Mellitus, Type 2 and Hypertension, run by McMaster University at 1 site in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03481335, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.

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