NCT02478853

Brief Summary

The prevention and control of lifestyle-related non-communicable chronic diseases, including diabetes, obesity and cardiovascular disorders, that share common risk factors, has now become a major focus of the World Health Organization. Lifestyle modification, like improvement of diet, physical activity and tobacco cessation, is the corner stone of diabetes and cardio-metabolic chronic diseases (CMCD) prevention and management. Under the leadership of decision-makers of our regional health Agency in order to improve accessibility and quality of care, our team has collaborated to the development and implementation of an integrated care framework for the prevention and management of cardio-metabolic chronic diseases in primary care. This new care framework is currently being implemented in the context of community health centers (fall 2014) and family medicine groups (spring 2015), with the support of a Quebec Ministry of Health grant. The current research proposal aims to evaluate the implementation of this new care framework and explore its impact in the primary care context. This project is very important as it will generate knowledge on new models of care integrating preventive and management interventions in primary care settings, in continuum with specialized health care services and their implementation in an entire region.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

2.8 years

First QC Date

April 20, 2015

Last Update Submit

December 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Implementation of the new care framework assessed with interviews, chart audit and questionnaires

    Investigators will assess implementation of the framework including barriers and facilitators, acceptability and perceived usefulness and the strategies used to implement

    36 months

Secondary Outcomes (10)

  • Patients' satisfaction measure with questionnaire

    36 months

  • Patients' health outcome measure with chart audit

    36 months

  • Primary care professionals' satisfaction measure with questionnaire

    36 months

  • Primary care professionals' practice measure with interviews

    36 months

  • Primary care professionals' self-efficacy measure with questionnaire

    36 months

  • +5 more secondary outcomes

Interventions

Integrated care framework for the prevention and management of cardio-metabolic chronic diseases in primary care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All healthcare professionals involved in CMCD management in the targeted clinics will be invited to participate (questionnaires and group interviews). All adult patients prospectively presenting at the targeted clinics will receive an invitation letter describing the project.

You may qualify if:

  • Healthcare professionals involved in CMCD management in the targeted clinics
  • Eligible patients should have at least one CMCD (diabetes, pre-diabetes, obesity, cardio- or cerebrovascular disease, hypertension, dyslipidemia) or be active smokers.

You may not qualify if:

  • Patients who are not able to fill out questionnaires with help

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityHypertensionDyslipidemiasCardiovascular DiseasesSmoking

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesLipid Metabolism DisordersBehavior

Study Officials

  • Marie-France Langlois, MD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

June 23, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2025

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations