NCT01719991

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
247

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

October 25, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

1.6 years

First QC Date

October 25, 2012

Last Update Submit

December 1, 2014

Conditions

Chronic Diseases

Keywords

Primary careSelf-managementSelf-supportNurse case management

Outcome Measures

Primary Outcomes (5)

  • 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.

    6 months

  • 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).

    6 months

  • Change in patient perception of health behaviours at 6 months

    Fruit and vegetable consumption, smoking status, alcohol consumption, healthy weight and physical activity.

    6 months

  • Change in patient perception of activation at 6 month

    Patient knowledge, skills and self-confidence in self-management measured by the Patient Activation instrument.

    6 months

  • Change in patient perception of psychological distress at 6 months

    Measured by the Psychological Distress instrument.

    6 months

Secondary Outcomes (3)

  • Change in patient perception of empowerment at 6 months.

    6 months

  • Change in patient perception of quality of life at 6 months

    6 months

  • Change in use of health services at 6 months

    6 months

Other Outcomes (3)

  • Socioeconomic status

    2 weeks before the intervention

  • Health literacy status

    2 weeks before the intervention

  • Mental health status

    2 weeks before the intervention

Study Arms (2)

Nurse case management and self-management support

EXPERIMENTAL

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.

Other: Nurse case management and self-management support

Control group

NO INTERVENTION

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).

Interventions

Nurse case management and self-management supportOTHER

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.

Nurse case management and self-management support

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Alma, Quebec, G8B 5W3, Canada

Location

Centre de santé et de services sociaux de Chicoutimi

Chicoutim, Quebec, G7H 5H6, Canada

Location

Related Publications (4)

  • 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.

    PMID: 29760027DERIVED

  • 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.

    PMID: 29523095DERIVED

  • 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.

    PMID: 28683743DERIVED

  • 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.

    PMID: 23391214DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Catherine Hudon, PhD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

  • Maud-Christine Chouinard, PhD

    Université du Québec à Chicoutimi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Pr

Study Record Dates

First Submitted

October 25, 2012

First Posted

November 1, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

CA(2)