DiabetesPhase 1/2CHAP-PNCT02479516
Community Health Assessment Program in the Philippines
A Phase 1/2 study testing Community Health Assessment Program Philippines (CHAP-P) in people with Diabetes, run by McMaster University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Community Health Assessment Program Philippines (CHAP-P)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Oct 2017
- Phase
- Phase 1/2
- 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
Who may be able to join
- Resident of the intervention community
Who cannot join
None listed.
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Community Health Assessment Program Philippines (CHAP-P)
- Keywords
- Diabetes screening, Health Promotion, Low and Middle Income Countries, CHAP
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Assessment Program Philippines (CHAP-P)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| CHAPP intervention communities | Experimental | 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 Receives: Behavioral: Community Health Assessment Program Philippines (CHAP-P) |
| Delayed Intervention communities | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elevated HBA1c
Measured: 6 months
Secondary outcomes (1)
Blood Pressure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Ateneo de Zamboanga University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479516
- Sponsor's protocol ID
- APP242122
- Acronym
- CHAP-P
- Status last verified
- Jun 2015
- First submitted
- 28 May 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Assessment Program in the Philippines
- ClinicalTrials.gov ID
- NCT02479516
- Acronym / sponsor ID
- CHAP-P / APP242122
- Conditions
- Diabetes
- Keywords
- Diabetes screening, Health Promotion, Low and Middle Income Countries, CHAP
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Ateneo de Zamboanga University
- Study start
- Nov 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHAPP intervention communities | Experimental | Behavioral: Community Health Assessment Program Philippines (CHAP-P)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 |
| Delayed Intervention communities | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Resident of the intervention community
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health Assessment Program Philippines (CHAP-P) | Behavioural | CHAPP intervention communities |
Primary outcome
Elevated HBA1c
Time frame: 6 months
1 secondary outcome
Blood Pressure
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Related InfoLink provided by the sponsor.
Related trials for Diabetes
Active, not recruitingPhase 3
Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Community Health Assessment Program Philippines (CHAP-P) in people with Diabetes, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Elevated HBA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2015.