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

June 19, 2015 updated by: McMaster University

The investigators are adopting an intervention which has been tested in Canada to the Philippine setting. The program will be called Community Health Assessment Program in the Philippines (CHAPP). The main goal of CHAPP is to decrease diabetes and its complications by implementing a community-based program.

The CHAPP intervention will be modified so that it will be applicable to the Philippine setting and other Low and Middle Income Countries. The initial plan for the program is that trained volunteers or health workers will be running the CHAPP sessions 2-hours a week in a community location for residents in the community. During the CHAPP session, volunteers will administer a questionnaire and do basic measures (assessing the weight, height, blood pressure, waist measurement). The questions can be entered into a laptop/tablet/cell-phone or written into a paper questionnaire depending on the abilities of the volunteer to use computers. Based on the data gathered, the volunteers will identify residents who have a high risk of developing diabetes (including long term complications of diabetes such as hypertension), educate them regarding what to do to avoid having diabetes (by doing exercise, improving their diet, and avoiding unhealthy lifestyle), and refer them to local health care when needed. Residents who have high risk of developing diabetes will be referred to have their blood sugar checked. Residents who have diabetes or complications of diabetes will be checked to see if they are being treated properly; if not they will be referred to the local doctor for treatment and medication. All the information regarding the CHAPP sessions will be sent to the Local Public Health Office or other designated local health centre so that they will be able to educate, monitor, and attend to residents who have diabetes or who have high risk of developing diabetes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Primary research question: What is the effect of CHAPP on diabetes awareness, detection and management in rural communities in Zamboanga Peninsula, Philippines?

Project Description:

This 5-year program will be carried out sequentially as an embedded mixed methods research project.

Objectives of the research:

  • To identify optimal ways to adapt elements of the CHAP model to fit local conditions (sociocultural, economic and environmental) and focussing on the prevention and management of diabetes
  • To evaluate the effectiveness, generalizability, and cost-effectiveness of the CHAPP intervention for use in rural communities in LMICs
  • To foster uptake of findings from the CHAPP program to other organizations and groups in the Philippines and other LMICs

Phase 1: Adaptation of CHAPP to the sociocultural and economic setting Design: Qualitative inquiry to modify and incorporate the CHAP intervention model to best fit the local setting in Zamboanga Peninsula.

Participants: Department of Health Personnel; Provincial Health Office Personnel; Municipal Mayor and barangay (local term for a small village) officials; Municipal Health Officers, Public Health Nurses and Midwives; Local Lead Organization representatives; CHAPP target participants (residents 40 years and older).Three municipalities will be selected from each province for the KII.

Research Instruments: Interview guides for use in individual and group interviews, document abstraction forms (to be developed once key documents have been identified).

Data Gathering Procedure: Document review, Key Informant Interviews (KII), Focus Group Discussions (FGDs), and directed exercises (free listing, pile sort and taxonomy building).

Data analysis and outcome: Thematic Framework Analysis (CITE).

Phase 2: Pilot project of CHAPP in selected rural communities Design: 6-month prospective pilot project. The CHAPP intervention protocol developed in phase 1 will be pilot tested in selected municipalities in the Zamboanga Peninsula.

Objective: To pilot test feasibility of the CHAPP The setting and study population: Two eligible communities Region IX. Target participants are permanent resident of qualified municipalities 40 years and older.

Community Participant Sampling: Cluster random sample of 400 residents 40 years of age and older will be generated for each pilot Municipality.

Other participants: CHAPP Local Lead Organizations (LLO) and volunteers, selected CHAPP participants, health workers (doctor, nurse, midwife).

CHAPP intervention: The proposed CHAPP intervention will include:

  • Diabetes risk assessment (modified FINRISK and assessment of lifestyle risk behaviours) sessions be at least every 2 weeks in accessible community locations, manned by trained volunteers of LLO
  • Volunteers educate CHAPP participants regarding their diabetes risk factors and ways to practice healthy lifestyle (including referral to local resources/activities) using diabetes education materials adapted for local context
  • Use of an accepted process have participant data transmitted to a central web database system through a combination of cell-phone and computer-based technology
  • Have participant assessment result forwarded to the Municipal Health Officer (doctor) for follow-up and screening Data Gathering Procedures: Participant survey (risk profile, physical activity, diet), data collected during CHAPP sessions, Community Process Evaluation Data Analysis and Outcomes: Ease of conduct, difficulties encounters, revisions needed

Phase 3: Effectiveness of CHAPP Design: Stepped-Wedge cluster RCT Objective: To determine if CHAPP program will significantly improve behaviours related to the prevention and treatment (physical activity, diet, medication use for diabetic patients) of diabetes among residents 40 years of age and older compared to usual care.

Randomization: The CHAPP will be implemented in 20 communities will be randomly selected, stratified by district and population size and randomly assigned to 1 of 4 wedges (5 communities per wedge).

Participant sampling: A cluster random sample of 400 residents 40 years of age and older will be generated for each of the 20 Municipalities at the onset.

Intervention: The CHAPP intervention will be implemented during intervention periods of selected communities. During control periods, communities will follow usual practice.

Research Instruments: Same research instruments will be used as in Phase 2 Primary outcome: For the general population, outcomes that will be assessed are physical activity measured by the International Physical Activity Questionnaire (IPAQ), Diet measured by the portions of the diet survey lines from the Behavioral Risk Factor Surveillance System (BRFSS) questionnaire. For diagnosed diabetics, outcome will also include medication compliance.

Secondary outcomes: Hospital admission rates and mortality rates due to diabetes and diabetes-related illness (based on International Classification of Disease-9 codes), number of newly diagnosed residents with diabetes, and changes in the BP and BMI of CHAPP participants.

Data collection: All data collection procedures will be similar to Phase 2 or may be modified based on the results of the pilot study and advice from the Advisory Committee.

Statistical analysis: The primary analysis will be to compare communities receiving the CHAPP intervention to those receiving regular care according to the stepped wedge schedule.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Resident of the intervention community

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CHAPP intervention communities

CHAPP intervention: The proposed CHAPP intervention will include:

  • Diabetes risk assessment (modified FINRISK and assessment of lifestyle risk behaviours) sessions be at least every 2 weeks in accessible community locations, manned by trained volunteers of LLO
  • Volunteers educate CHAPP participants regarding their diabetes risk factors and ways to practice healthy lifestyle (including referral to local resources/activities) using diabetes education materials adapted for local context
  • Use of an accepted process have participant data transmitted to a central web database system through a combination of cell-phone and computer-based technology
  • Have participant assessment result forwarded to the Municipal Health Officer (doctor) for follow-up and screening
Behavioral: Community Health Assessment Program Philippines (CHAP-P)
No Intervention: Delayed Intervention communities

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Elevated HBA1c
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Blood Pressure
Time Frame: 6 months
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Health Behaviour questionnaire
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ateneo de Zamboanga University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APP242122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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