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Completed

NCT Number: NCT01719991

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de santé et de services sociaux Lac-Saint-Jean-Est, Alma, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse case management and self-management support

Other

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 outcomes

  1. Change in patient perception of personal self-efficacy at 6 months

    Time frame: 6 months

    The patient capacity to self-management measured by the Self-Efficacy for Managing Chronic Disease instrument.

  2. Change in patient perception of self-management practice at 6 months

    Time frame: 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).

  3. Change in patient perception of health behaviours at 6 months

    Time frame: 6 months

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

  4. Change in patient perception of activation at 6 month

    Time frame: 6 months

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

  5. Change in patient perception of psychological distress at 6 months

    Time frame: 6 months

    Measured by the Psychological Distress instrument.

Secondary outcomes

  1. Change in patient perception of empowerment at 6 months.

    Time frame: 6 months

    Health education impact measured by the Health Education Impact Questionnaire (HEIQ).

  2. Change in patient perception of quality of life at 6 months

    Time frame: 6 months

    Measured by the 12-Item Short Form Health Survey

  3. Change in use of health services at 6 months

    Time frame: 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.

Other outcomes

  1. Socioeconomic status

    Time frame: 2 weeks before the intervention

  2. Health literacy status

    Time frame: 2 weeks before the intervention

    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.

  3. Mental health status

    Time frame: 2 weeks before the intervention

    Measured by the Hospital Anxiety and Depression Scale.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

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

Registry information

Official study title

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

Acronym: V1SAGES

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 1, 2012
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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