Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT02479516 |
| Other study ID # |
APP242122 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 1/Phase 2
|
| First received |
May 28, 2015 |
| Last updated |
June 19, 2015 |
| Start date |
November 2015 |
| Est. completion date |
October 2017 |
Study information
| Verified date |
June 2015 |
| Source |
McMaster University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Canada: Canadian Institutes of Health Research |
| Study type |
Interventional
|
Clinical 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.
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.
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.
