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Integration of Chronic Disease Rehabilitation Services Into Primary Care (PR1MaC)

Primary Purpose

Cardiovascular Disease, Heart Failure, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Support, management, educational, counselling, follow-up
Sponsored by
Martin Fortin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiovascular Disease focused on measuring Chronic diseases, Primary care, Rehabilitation, Chronic Care Model, Patient centered medical home

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • present at least one of the following conditions: type 2 diabetes, CVD, heart failure, risk factors (smoking, obesity, hyperlipidemia, glucose intolerance, and metabolic syndrome), COPD or asthma.
  • have the potential for rehabilitation

Exclusion Criteria:

  • serious cognitive problems

Sites / Locations

  • CSSS de Chicoutimi, Unité de médecine de famille

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Group A

Group B

Group C

Arm Description

Intervention group(n = 163)

Delayed intervention (n = 163)

No intervention group (n = 163)

Outcomes

Primary Outcome Measures

Evaluation of effects
Short term: Self-Efficacy Managing Chronic Disease scale: SEMCD Health Education Impact questionnaire: heiQ Medium term: Risk factors Functional health status/quality of life: SF12 Psychological well being: K6 Other: Socio-demographic: SD comorbidity co-intervention (CI) Visites: 1:(week:- 2) : Group A and B: DBMA; SD; SF12; K6; SEMCD, heiQ 2a:(week:0) : Group A, (week:12) for Group B: SEMCD, heiQ; CI 2b, 2c: (weeks:4, 8) : Group A: CI 3:(weeks:12) : Group A: SEMCD, heiQ; CI 4:(weeks:52) : Group A: SF12, K6; SEMCD, heiQ; CI

Secondary Outcome Measures

Full Information

First Posted
March 21, 2011
Last Updated
September 27, 2021
Sponsor
Martin Fortin
Collaborators
Pfizer, Fonds de la Recherche en Santé du Québec, Ministere de la Sante et des Services Sociaux, Centre de santé et de services sociaux de Chicoutimi, Centre de santé et de services sociaux de Jonquière
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1. Study Identification

Unique Protocol Identification Number
NCT01319656
Brief Title
Integration of Chronic Disease Rehabilitation Services Into Primary Care
Acronym
PR1MaC
Official Title
Adaptation, Implementation and Evaluation of an Intervention Involving the Integration of Chronic Disease Rehabilitation Services Into Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Martin Fortin
Collaborators
Pfizer, Fonds de la Recherche en Santé du Québec, Ministere de la Sante et des Services Sociaux, Centre de santé et de services sociaux de Chicoutimi, Centre de santé et de services sociaux de Jonquière

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of PR1MaC is to establish a clinical intervention that will adapt and permanently integrate rehabilitation services into primary care settings, which would be the reference point in the health care system for people with Chronic diseases (CD). More specifically, the intervention will aim to: (1) clinically operationalize the mechanisms and tools necessary for delivery of integrated CD services, promoting continuity of care in response to the needs expressed by stakeholders; (2) implement and deploy rehabilitation services adapted to the realities of various clinical primary care settings and develop tools to ensure the sustainability of interventions beyond the rehabilitation period; and (3) support clinical primary care teams in the acquisition and maintenance of evidence-based practices for the targeted CDs.
Detailed Description
Since 2001, professionals in the Saguenay-Lac-Saint-Jean (SLSJ) region in Quebec province, Canada, have been mobilized to deal with the challenges of CD management by the introduction of the SLSJ Trajectory of Integrated Rehabilitation Services for CD (Trajectoire des services de réadaptation intégrés pour MC du SLSJ), hereafter referred to as the "Trajectoire." This Trajectoire, deployed across the region, constitutes a solid network of rehabilitation services, due as much to the resources granted to it and its evidence-based approach as to the appreciation that patients and professionals within the regional health system have for it. The changes and new directions that have taken place in recent years suggest it is time to improve this Trajectoire by promoting greater integration with primary care services to improve accessibility, the complementarity of services and better post-rehabilitation continuity. The proposed intervention involves the adaptation and integration of rehabilitation services under the Trajectoire's leadership within primary care settings (FMG or medical clinics), so that collaborative work routines are developed and implemented directly at the main place of contact with health services for people with a CD. The intervention will be implemented at the CSSSs in Chicoutimi and Jonquière. This logic model was developed in collaboration with researchers, clinicians and decision-makers involved in this application and discussed at meetings for the preparation of this application. The model's first component (objective 1) will consist of a consultation with stakeholders (primary care professionals, Trajectoire professionals) by sharing information about the current range of services. In each area, the consultation will include a needs evaluation and a reflection on the Trajectoire's services that can be adapted for targeted clients. As each clinic where an intervention will be deployed has its own mode of operation and clientele characteristics, the clinical intervention will be specifically adapted to these considerations and prepared in collaboration with each clinical setting to ensure a range of services that meets the expressed needs. The second component (objective 2) will be to implement and deploy a range of concerted interdisciplinary services adapted to the client services and professional resources already in place. Services that do not require specialized equipment or adapted premises (a gym, for example) can be integrated, including educational/teaching services (self-care, support to stop smoking, nutrition, etc.). In medical clinics currently not offering these services, the addition will be net, while in those that already rely on the services of nurse practitioners (FMG), the addition of these services will complement existing services. During this period, various mechanisms and clinical information sharing tools will be implemented jointly by professionals. The third component will be to implement a support mechanism and ongoing evaluation within the clinical setting to ensure harmonious integration. If necessary, training workshops will be provided to implement or maintain evidence-based practices and to plan longer-term follow-up of clientele and continuity of interventions. The intervention: (a) will be educational in nature, patient-centred and based on the Trajectoire; (b) will last at least three months and involve at least three meetings; (c) may include meetings with small patient groups or the involvement of a close relative of the patient (spouse or primary caregiver); (d) will be carried out based on a referral from the primary care team according to defined criteria; (e) will allow an exchange with the primary care team and will be integrated into the primary care medical records; (f) will provide for a transfer of responsibility to the primary care team to ensure ongoing long-term follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Heart Failure, Chronic Obstructive Pulmonary Disease, Asthma, Diabetes
Keywords
Chronic diseases, Primary care, Rehabilitation, Chronic Care Model, Patient centered medical home

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Intervention group(n = 163)
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Delayed intervention (n = 163)
Arm Title
Group C
Arm Type
No Intervention
Arm Description
No intervention group (n = 163)
Intervention Type
Behavioral
Intervention Name(s)
Support, management, educational, counselling, follow-up
Other Intervention Name(s)
dietetics, respiratory therapy, smoking cessation, physical activity, Stress management, Psychosocial support, Drug compliance
Intervention Description
The project offers a range of activities (educational, counselling, follow-up) by several professionals. The varied range of services is spread out over six months and may include individual or group meetings with professionals. Informational documents and follow-up tools are provided to patients based on their condition, to facilitate the acquisition and maintenance of knowledge, self-management, and changes in risk behaviour.
Primary Outcome Measure Information:
Title
Evaluation of effects
Description
Short term: Self-Efficacy Managing Chronic Disease scale: SEMCD Health Education Impact questionnaire: heiQ Medium term: Risk factors Functional health status/quality of life: SF12 Psychological well being: K6 Other: Socio-demographic: SD comorbidity co-intervention (CI) Visites: 1:(week:- 2) : Group A and B: DBMA; SD; SF12; K6; SEMCD, heiQ 2a:(week:0) : Group A, (week:12) for Group B: SEMCD, heiQ; CI 2b, 2c: (weeks:4, 8) : Group A: CI 3:(weeks:12) : Group A: SEMCD, heiQ; CI 4:(weeks:52) : Group A: SF12, K6; SEMCD, heiQ; CI
Time Frame
T1: Initial evaluation; T2: after three months; T3: one year after T1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: present at least one of the following conditions: type 2 diabetes, CVD, heart failure, risk factors (smoking, obesity, hyperlipidemia, glucose intolerance, and metabolic syndrome), COPD or asthma. have the potential for rehabilitation Exclusion Criteria: serious cognitive problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Fortin, MD, M.Sc.
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
CSSS de Chicoutimi, Unité de médecine de famille
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada

12. IPD Sharing Statement

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Links:
URL
http://www.usherbrooke.ca/crmcspl/en/
Description
CIHR Applied Research Chair - Health Services and Policy Research on Chronic Diseases in Primary Care
URL
http://www.santesaglac.gouv.qc.ca/
Description
Agence de la santé et des services sociaux du Saguenay-Lac-Saint-Jean
URL
http://www.usherbrooke.ca
Description
Université de Sherbrooke
URL
http://www.uqac.ca
Description
Université du Québec à Chicoutimi

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Integration of Chronic Disease Rehabilitation Services Into Primary Care

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