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Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support (V1SAGES)

Primary Purpose

Chronic Diseases

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nurse case management and self-management support
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Diseases focused on measuring Primary care, Self-management, Self-support, Nurse case management

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient of the participating FMGs
  • Aged between 25 and 80 years
  • Affected by chronic disease (diabetes, cardiovascular diseases, respiratory diseases, musculoskeletal diseases and/or chronic pain)
  • Identified as a frequent user of health services (by a health care provider or/and a software)

Exclusion Criteria:

  • Patient unable to provide consent
  • With cognitive impairment
  • With uncontrolled psychiatric illness
  • Patient with a prognostic of less than one years

Sites / Locations

  • Centre de santé et de services sociaux Lac-Saint-Jean-Est
  • Centre de santé et de services sociaux de Chicoutimi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nurse case management and self-management support

Control group

Arm Description

The first component of the intervention is the monitoring offered under the case management process. The second component of the intervention consists of group meetings (10-12 people) for self-management support in accordance with the stanford model. A sample of patients in each of the four FMGs (n = 126) will be recruited. These patients will receive the intervention for six months.

Patients in the control group (n = 121) will receive the usual care for six months and then the same intervention as the experimental group for the next five months (waiting list control group).

Outcomes

Primary Outcome Measures

Change in patient perception of personal self-efficacy at 6 months
The patient capacity to self-management measured by the Self-Efficacy for Managing Chronic Disease instrument.
Change in patient perception of self-management practice at 6 months
The patient capacity to manage their condition and their physical and psychological reaction measured by a subscale of the Health Education Impact Questionnaire (HEIQ).
Change in patient perception of health behaviours at 6 months
Fruit and vegetable consumption, smoking status, alcohol consumption, healthy weight and physical activity.
Change in patient perception of activation at 6 month
Patient knowledge, skills and self-confidence in self-management measured by the Patient Activation instrument.
Change in patient perception of psychological distress at 6 months
Measured by the Psychological Distress instrument.

Secondary Outcome Measures

Change in patient perception of empowerment at 6 months.
Health education impact measured by the Health Education Impact Questionnaire (HEIQ).
Change in patient perception of quality of life at 6 months
Measured by the 12-Item Short Form Health Survey
Change in use of health services at 6 months
Measured by hospitalizations, emergency room visits and health services use(e.g., psychosocial services or specialized services related to the specific chronic disease.

Full Information

First Posted
October 25, 2012
Last Updated
December 1, 2014
Sponsor
Université de Sherbrooke
Collaborators
Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean, Centre de santé et de services sociaux de Chicoutimi, Fonds de la Recherche en Santé du Québec
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1. Study Identification

Unique Protocol Identification Number
NCT01719991
Brief Title
Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support
Acronym
V1SAGES
Official Title
Pragmatic Evaluation of Case Management and Self-management Support for Vulnerable People With Chronic Diseases in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean, Centre de santé et de services sociaux de Chicoutimi, Fonds de la Recherche en Santé du Québec

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to implement a pragmatic intervention in four (4) family medicine groups(FMGs) in the region of Saguenay-Lac-Saint-Jean (Quebec, Canada)for patients with chronic diseases.
Detailed Description
Chronic diseases represent a major health burden worldwide. Some people with chronic diseases require a higher level of care due to personal characteristics that increase their vulnerability. For these patients, nurse effective case management in primary care are associated with positive outcomes. Moreover, self-management programs, such as the standford program developed by the School of Medicine at the University of Standford in California (USA), are also recognized for their benefits on patients with chronic diseases. The aim of our project is to implement, within four (4) FMGs of the region of Saguenay-Lac-Saint-Jean , a practical intervention involving case management by a nurse to promote interdisciplinary person-centered monitoring and self-management support for highly vulnerable individuals with chronic diseases (diabetes, cardiovascular diseases, respiratory diseases, musculoskeletal diseases and/or chronic pain). The objectives of our study : 1) To analyze the implementation of the intervention in the participating FMGs in order to determine how the various contexts have influenced the implementation and the observed effects; 2) To evaluate the proximal and intermediate effects of the intervention on patients; 3) To conduct an economic analysis of the effectiveness and cost-benefit of the intervention. The analysis of the implementation will be conducted using realistic evaluation approaches and participatory practice within four categories of key players (FMG stakeholders, FMG/health center managers, patients and their families, health center partners or communities). The data will be obtained through individual or group interviews, literature reviews and documentation from the intervention undertaken. The evaluation of the effects in patients will be based on a pragmatic randomized experimental design before and after (six months) with delayed intervention in the control group. Economic analysis will include a cost-effectiveness analysis and a cost-benefit analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diseases
Keywords
Primary care, Self-management, Self-support, Nurse case management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nurse case management and self-management support
Arm Type
Experimental
Arm Description
The first component of the intervention is the monitoring offered under the case management process. The second component of the intervention consists of group meetings (10-12 people) for self-management support in accordance with the stanford model. A sample of patients in each of the four FMGs (n = 126) will be recruited. These patients will receive the intervention for six months.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in the control group (n = 121) will receive the usual care for six months and then the same intervention as the experimental group for the next five months (waiting list control group).
Intervention Type
Other
Intervention Name(s)
Nurse case management and self-management support
Intervention Description
Case management: The intervention will focus on four main components: (1) A thorough evaluation of the patient's needs and resources; (2) Establishing and maintaining a patient-centered, individualized service plan (ISP); (3) Coordination of services among partners; and (4) Self-management support for patients and their families. Self-management support: A standardized six-week program with interactive weekly group meetings led by two volunteer peer helpers (appointed trainers), who themselves have a chronic disease.
Primary Outcome Measure Information:
Title
Change in patient perception of personal self-efficacy at 6 months
Description
The patient capacity to self-management measured by the Self-Efficacy for Managing Chronic Disease instrument.
Time Frame
6 months
Title
Change in patient perception of self-management practice at 6 months
Description
The patient capacity to manage their condition and their physical and psychological reaction measured by a subscale of the Health Education Impact Questionnaire (HEIQ).
Time Frame
6 months
Title
Change in patient perception of health behaviours at 6 months
Description
Fruit and vegetable consumption, smoking status, alcohol consumption, healthy weight and physical activity.
Time Frame
6 months
Title
Change in patient perception of activation at 6 month
Description
Patient knowledge, skills and self-confidence in self-management measured by the Patient Activation instrument.
Time Frame
6 months
Title
Change in patient perception of psychological distress at 6 months
Description
Measured by the Psychological Distress instrument.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in patient perception of empowerment at 6 months.
Description
Health education impact measured by the Health Education Impact Questionnaire (HEIQ).
Time Frame
6 months
Title
Change in patient perception of quality of life at 6 months
Description
Measured by the 12-Item Short Form Health Survey
Time Frame
6 months
Title
Change in use of health services at 6 months
Description
Measured by hospitalizations, emergency room visits and health services use(e.g., psychosocial services or specialized services related to the specific chronic disease.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Socioeconomic status
Time Frame
2 weeks before the intervention
Title
Health literacy status
Description
The degree to which individuals have the capacity to obtain, process and understand basic health information and services needed to make appropriate health decisions measured by the Newest Vital Sign.
Time Frame
2 weeks before the intervention
Title
Mental health status
Description
Measured by the Hospital Anxiety and Depression Scale.
Time Frame
2 weeks before the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient of the participating FMGs Aged between 25 and 80 years Affected by chronic disease (diabetes, cardiovascular diseases, respiratory diseases, musculoskeletal diseases and/or chronic pain) Identified as a frequent user of health services (by a health care provider or/and a software) Exclusion Criteria: Patient unable to provide consent With cognitive impairment With uncontrolled psychiatric illness Patient with a prognostic of less than one years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Hudon, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maud-Christine Chouinard, PhD
Organizational Affiliation
Université du Québec à Chicoutimi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de santé et de services sociaux Lac-Saint-Jean-Est
City
Alma
State/Province
Quebec
ZIP/Postal Code
G8B 5W3
Country
Canada
Facility Name
Centre de santé et de services sociaux de Chicoutimi
City
Chicoutim
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29760027
Citation
Hudon C, Chouinard MC, Dubois MF, Roberge P, Loignon C, Tchouaket E, Lambert M, Hudon E, Diadiou F, Bouliane D. Case Management in Primary Care for Frequent Users of Health Care Services: A Mixed Methods Study. Ann Fam Med. 2018 May;16(3):232-239. doi: 10.1370/afm.2233.
Results Reference
derived
PubMed Identifier
29523095
Citation
Couture EM, Chouinard MC, Fortin M, Hudon C. The relationship between health literacy and patient activation among frequent users of healthcare services: a cross-sectional study. BMC Fam Pract. 2018 Mar 9;19(1):38. doi: 10.1186/s12875-018-0724-7.
Results Reference
derived
PubMed Identifier
28683743
Citation
Couture EM, Chouinard MC, Fortin M, Hudon C. The relationship between health literacy and quality of life among frequent users of health care services: a cross-sectional study. Health Qual Life Outcomes. 2017 Jul 6;15(1):137. doi: 10.1186/s12955-017-0716-7.
Results Reference
derived
PubMed Identifier
23391214
Citation
Chouinard MC, Hudon C, Dubois MF, Roberge P, Loignon C, Tchouaket E, Fortin M, Couture EM, Sasseville M. Case management and self-management support for frequent users with chronic disease in primary care: a pragmatic randomized controlled trial. BMC Health Serv Res. 2013 Feb 7;13:49. doi: 10.1186/1472-6963-13-49.
Results Reference
derived

Learn more about this trial

Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support

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