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Diabetes Mellitus, Type 2NCT02478853

Impact of a Regional Program Agir Sur Sa SantE

An observational study of Diabetes Mellitus, Type 2 and Obesity, run by Université de Sherbrooke at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2, Obesity, Hypertension
What is being tested?
Implementation of a new regional care framework
How many people
1,000 participants
Where
1 siteCanada
Study dates
Mar 2015to Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre de recherche du CHUS

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

Official title: Agir Sur Sa SantE- Impact of a Regional Integrated Prevention and Management of Cardio-metabolic Chronic Diseases Program in Primary Care

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.

Read the detailed description

BACKGROUND: In an era where cardio-metabolic chronic diseases (CMCD) take epidemic proportions, health systems have to react by providing care to manage but also to prevent them. Our region has demonstrated leadership in developing and implementing regional care frameworks and patient trajectories defining services throughout the continuum of care (from community to primary to specialized care). However, these diabetes, cardiac rehabilitation and 0-5-30 prevention programs have been implemented in silos. Under the leadership of decision-makers of our regional health Agency, in order to improve accessibility and quality of care, our team has worked on the development and implementation of an integrated care framework for the prevention and management of cardio-metabolic chronic diseases: Agir Sur Sa SantÉ (ASSSÉ). This new framework, based on individual/group motivational techniques, care protocols and collective orders, is currently being implemented in the context of community health centers (CSSS). The investigators recently received a Quebec Ministry of Health grant to continue supporting the implementation in CSSS, implement the care framework in family medicine groups (FMG; spring 2015) and initiate some baseline evaluations (satisfaction and perceptions questionnaires). The investigators hypothesize that successful implementation of ASSSÉ could improve accessibility indicators, for patients affected or at risk for CMCD, patient and primary care personnel satisfaction, fidelity, quality and continuity of care in the context of FMGs.

OBJECTIVES: The investigators aim to:

  1. Analyze the implementation process of the new ASSSÉ framework in the context of FMGs by: a) establishing its acceptability and perceived usefulness by patients and health professionals; b) identifying the determinants (barriers and facilitators) of its implementation; c) describing the strategies used to implement the ASSSÉ care framework in FMGs.
  2. Estimate the size of the effects of ASSSÉ (including main effects and variability of effects across FMGs to allow for informed sample size calculation in the planning of a future large-scale trial) on: a) patients (satisfaction, health outcomes); b) primary care professionals (practice, satisfaction, self-efficacy); c) health care system (organizational and technical quality of care indicators, accessibility and continuity of care indicators, fidelity of care to framework).
  3. Effectively share knowledge obtained through these activities to relevant stakeholders in the health care and public health sectors, including policy makers, decision makers, health care professionals and patients using innovative tools and approaches.

METHODS AND APPROACH: This participatory research project will use a mixed-method approach combining qualitative and quantitative assessments. The project will be conducted in three steps: 1-Pre-implementation evaluation: Services and patient trajectories currently provided in all 14 FMGs of the Eastern Townships will be assessed using chart reviews to evaluate technical quality of care indicators and health outcomes. The investigators will also use questionnaires evaluating the concordance with the Expended chronic care model, self-efficacy, satisfaction of personnel and patients, and potential areas to target for improvement to assess organizational quality of care. Questionnaires and semi-structured group interviews with health professionals, decision-makers and patients with, or at risk for, CMCD will also be performed; 2- Post-implementation evaluation and data analysis: 12, 24 and 36 months after initiation of implementation, the investigators will perform a similar evaluation as done in the initial phase. Semi-structured group interviews will only be repeated at 24 months. Pre- and post-implementation comparisons will be performed using paired t-tests for continuous variables and McNemar tests for dichotomous variables to identify areas of improvement and persistent gaps. 3-Knowledge translation(KT): Integrated KT is an important outcome of this research, has already begun and will occur throughout the project with the various actors involved. The investigators will also reach out to various target audiences (health professionals, decision-makers and policy-makers, patients and Canadian population) through classic end-of-grant KT and the production of a clear executive summary of research results.

IMPACT: Considering the epidemic of chronic diseases, this project is very important as it will generate knowledge on models of care integrating preventive and management interventions of multiple conditions in primary care, in continuum with specialized health care services. It also has high transferability potential in various provincial and disease contexts.

Being tested
Implementation of a new regional care framework
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Hypertension, Dyslipidemias, Cardiovascular Diseases, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implementation of a new regional care frameworkOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 36 months

Secondary outcomes (10)
  1. Patients' satisfaction measure with questionnaire

    Patients' satisfaction

    Measured: 36 months

  2. Patients' health outcome measure with chart audit

    Health outcome such as weight, HbA1c,...

    Measured: 36 months

  3. Primary care professionals' satisfaction measure with questionnaire

    Primary care professionals' satisfaction

    Measured: 36 months

  4. Primary care professionals' practice measure with interviews

    Primary care professionals' practice

    Measured: 36 months

  5. Primary care professionals' self-efficacy measure with questionnaire

    Primary care professionals' self-efficacy

    Measured: 36 months

  6. Organizational quality of care indicators measure with questionnaire

    Organizational quality of care indicators

    Measured: 36 months

  7. Technical quality of care indicators measure with chart audit

    Technical quality of care indicators

    Measured: 36 months

  8. Accessibility of care indicators measure with administrative data

    Accessibility of care indicators

    Measured: 36 months

  9. Continuity of care indicators measure with chart audit

    Continuity of care indicators

    Measured: 36 months

  10. Fidelity of care to framework measure with chart audit

    Fidelity of care to framework

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionDec 2017
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02478853
Sponsor's protocol ID
CCER 14-15 -15
Status last verified
Dec 2024
First submitted
20 Apr 2015
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2 and Obesity, run by Université de Sherbrooke at 1 site in Canada.

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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Implementation of the new care framework assessed with interviews, chart audit and questionnaires (time frame: 36 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 9 Dec 2024.

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