<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01719991</url>
  </required_header>
  <id_info>
    <org_study_id>FRSQ-26758</org_study_id>
    <nct_id>NCT01719991</nct_id>
  </id_info>
  <brief_title>Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support</brief_title>
  <acronym>V1SAGES</acronym>
  <official_title>Pragmatic Evaluation of Case Management and Self-management Support for Vulnerable People With Chronic Diseases in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Sherbrooke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre de santé et de services sociaux de Chicoutimi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fonds de la Recherche en Santé du Québec</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Université de Sherbrooke</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to implement a pragmatic intervention in four (4) family&#xD;
      medicine groups(FMGs) in the region of Saguenay-Lac-Saint-Jean (Quebec, Canada)for patients&#xD;
      with chronic diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic diseases represent a major health burden worldwide. Some people with chronic diseases&#xD;
      require a higher level of care due to personal characteristics that increase their&#xD;
      vulnerability. For these patients, nurse effective case management in primary care are&#xD;
      associated with positive outcomes. Moreover, self-management programs, such as the standford&#xD;
      program developed by the School of Medicine at the University of Standford in California&#xD;
      (USA), are also recognized for their benefits on patients with chronic diseases.&#xD;
&#xD;
      The aim of our project is to implement, within four (4) FMGs of the region of&#xD;
      Saguenay-Lac-Saint-Jean , a practical intervention involving case management by a nurse to&#xD;
      promote interdisciplinary person-centered monitoring and self-management support for highly&#xD;
      vulnerable individuals with chronic diseases (diabetes, cardiovascular diseases, respiratory&#xD;
      diseases, musculoskeletal diseases and/or chronic pain).&#xD;
&#xD;
      The objectives of our study : 1) To analyze the implementation of the intervention in the&#xD;
      participating FMGs in order to determine how the various contexts have influenced the&#xD;
      implementation and the observed effects; 2) To evaluate the proximal and intermediate effects&#xD;
      of the intervention on patients; 3) To conduct an economic analysis of the effectiveness and&#xD;
      cost-benefit of the intervention.&#xD;
&#xD;
      The analysis of the implementation will be conducted using realistic evaluation approaches&#xD;
      and participatory practice within four categories of key players (FMG stakeholders,&#xD;
      FMG/health center managers, patients and their families, health center partners or&#xD;
      communities). The data will be obtained through individual or group interviews, literature&#xD;
      reviews and documentation from the intervention undertaken. The evaluation of the effects in&#xD;
      patients will be based on a pragmatic randomized experimental design before and after (six&#xD;
      months) with delayed intervention in the control group. Economic analysis will include a&#xD;
      cost-effectiveness analysis and a cost-benefit analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in patient perception of personal self-efficacy at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>The patient capacity to self-management measured by the Self-Efficacy for Managing Chronic Disease instrument.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patient perception of self-management practice at 6 months</measure>
    <time_frame>6 months</time_frame>
    <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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patient perception of health behaviours at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Fruit and vegetable consumption, smoking status, alcohol consumption, healthy weight and physical activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patient perception of activation at 6 month</measure>
    <time_frame>6 months</time_frame>
    <description>Patient knowledge, skills and self-confidence in self-management measured by the Patient Activation instrument.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patient perception of psychological distress at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by the Psychological Distress instrument.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in patient perception of empowerment at 6 months.</measure>
    <time_frame>6 months</time_frame>
    <description>Health education impact measured by the Health Education Impact Questionnaire (HEIQ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient perception of quality of life at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by the 12-Item Short Form Health Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in use of health services at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by hospitalizations, emergency room visits and health services use(e.g., psychosocial services or specialized services related to the specific chronic disease.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Socioeconomic status</measure>
    <time_frame>2 weeks before the intervention</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Health literacy status</measure>
    <time_frame>2 weeks before the intervention</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Mental health status</measure>
    <time_frame>2 weeks before the intervention</time_frame>
    <description>Measured by the Hospital Anxiety and Depression Scale.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">247</enrollment>
  <condition>Chronic Diseases</condition>
  <arm_group>
    <arm_group_label>Nurse case management and self-management support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nurse case management and self-management support</intervention_name>
    <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.&#xD;
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.</description>
    <arm_group_label>Nurse case management and self-management support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient of the participating FMGs&#xD;
&#xD;
          -  Aged between 25 and 80 years&#xD;
&#xD;
          -  Affected by chronic disease (diabetes, cardiovascular diseases, respiratory diseases,&#xD;
             musculoskeletal diseases and/or chronic pain)&#xD;
&#xD;
          -  Identified as a frequent user of health services (by a health care provider or/and a&#xD;
             software)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unable to provide consent&#xD;
&#xD;
          -  With cognitive impairment&#xD;
&#xD;
          -  With uncontrolled psychiatric illness&#xD;
&#xD;
          -  Patient with a prognostic of less than one years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine Hudon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université de Sherbrooke</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maud-Christine Chouinard, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université du Québec à Chicoutimi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre de santé et de services sociaux Lac-Saint-Jean-Est</name>
      <address>
        <city>Alma</city>
        <state>Quebec</state>
        <zip>G8B 5W3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de santé et de services sociaux de Chicoutimi</name>
      <address>
        <city>Chicoutim</city>
        <state>Quebec</state>
        <zip>G7H 5H6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>December 1, 2014</last_update_submitted>
  <last_update_submitted_qc>December 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université de Sherbrooke</investigator_affiliation>
    <investigator_full_name>Catherine Hudon</investigator_full_name>
    <investigator_title>MD, Pr</investigator_title>
  </responsible_party>
  <keyword>Primary care</keyword>
  <keyword>Self-management</keyword>
  <keyword>Self-support</keyword>
  <keyword>Nurse case management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01719991
org study id: FRSQ-26758
nct id: NCT01719991
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in patient perception of personal self-efficacy at 6 months
time frame: 6 months
description: The patient capacity to self-management measured by the Self-Efficacy for Managing Chronic Disease instrument.
measure: Change in patient perception of self-management practice at 6 months
time frame: 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).
measure: Change in patient perception of health behaviours at 6 months
time frame: 6 months
description: Fruit and vegetable consumption, smoking status, alcohol consumption, healthy weight and physical activity.
measure: Change in patient perception of activation at 6 month
time frame: 6 months
description: Patient knowledge, skills and self-confidence in self-management measured by the Patient Activation instrument.
measure: Change in patient perception of psychological distress at 6 months
time frame: 6 months
description: Measured by the Psychological Distress instrument.
measure: Change in patient perception of empowerment at 6 months.
time frame: 6 months
description: Health education impact measured by the Health Education Impact Questionnaire (HEIQ).
measure: Change in patient perception of quality of life at 6 months
time frame: 6 months
description: Measured by the 12-Item Short Form Health Survey
measure: Change in use of health services at 6 months
time frame: 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.
measure: Socioeconomic status
time frame: 2 weeks before the intervention
measure: Health literacy status
time frame: 2 weeks before the intervention
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.
measure: Mental health status
time frame: 2 weeks before the intervention
description: Measured by the Hospital Anxiety and Depression Scale.
arm group label: Nurse case management and self-management support
arm group type: Experimental
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 group label: Control group
arm group type: No Intervention
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: Nurse case management and self-management support
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.
arm group label: Nurse case management and self-management support
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Catherine Hudon, PhD
role: Principal Investigator
affiliation: Université de Sherbrooke
last name: Maud-Christine Chouinard, PhD
role: Principal Investigator
affiliation: Université du Québec à Chicoutimi
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Université de Sherbrooke
investigator full name: Catherine Hudon
investigator title: MD, Pr
mesh term: Chronic Disease