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

Pragmatic Evaluation of Case Management and Self-management Support for Vulnerable People With Chronic Diseases in Primary Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01719991
Acronym
V1SAGES
Enrollment
247
Registered
2012-11-01
Start date
2012-11-30
Completion date
2014-09-30
Last updated
2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Diseases

Keywords

Primary care, Self-management, Self-support, Nurse case management

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.

Interventions

OTHERNurse case management and self-management support

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.

Sponsors

Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean
CollaboratorOTHER
Centre de santé et de services sociaux de Chicoutimi
CollaboratorOTHER
Fonds de la Recherche en Santé du Québec
CollaboratorOTHER_GOV
Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in patient perception of health behaviours at 6 months6 monthsFruit and vegetable consumption, smoking status, alcohol consumption, healthy weight and physical activity.
Change in patient perception of personal self-efficacy at 6 months6 monthsThe 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 months6 monthsThe 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 psychological distress at 6 months6 monthsMeasured by the Psychological Distress instrument.
Change in patient perception of activation at 6 month6 monthsPatient knowledge, skills and self-confidence in self-management measured by the Patient Activation instrument.

Secondary

MeasureTime frameDescription
Change in use of health services at 6 months6 monthsMeasured by hospitalizations, emergency room visits and health services use(e.g., psychosocial services or specialized services related to the specific chronic disease.
Change in patient perception of empowerment at 6 months.6 monthsHealth education impact measured by the Health Education Impact Questionnaire (HEIQ).
Change in patient perception of quality of life at 6 months6 monthsMeasured by the 12-Item Short Form Health Survey

Other

MeasureTime frameDescription
Socioeconomic status2 weeks before the intervention
Mental health status2 weeks before the interventionMeasured by the Hospital Anxiety and Depression Scale.
Health literacy status2 weeks before the interventionThe 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026