NCT02479516

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_1 diabetes

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

1.9 years

First QC Date

May 28, 2015

Last Update Submit

June 19, 2015

Conditions

Keywords

Diabetes screeningHealth PromotionLow and Middle Income CountriesCHAP

Outcome Measures

Primary Outcomes (1)

  • Elevated HBA1c

    6 months

Secondary Outcomes (1)

  • Blood Pressure

    6 months

Other Outcomes (1)

  • Health Behaviour questionnaire

    6 months

Study Arms (2)

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

Behavioral: Community Health Assessment Program Philippines (CHAP-P)

Delayed Intervention communities

NO INTERVENTION

Interventions

CHAPP intervention communities

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resident of the intervention community

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 24, 2015

Study Start

November 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

June 24, 2015

Record last verified: 2015-06