<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/NCT02209285</url>
  </required_header>
  <id_info>
    <org_study_id>STRCT- 06669</org_study_id>
    <nct_id>NCT02209285</nct_id>
  </id_info>
  <brief_title>Self-Management Program for Older Adults With Multimorbidity</brief_title>
  <official_title>Self-Management Program for Older Adults With Multimorbidity: A Pragmatic Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with multimorbidity move between multiple care settings, and so they are at high&#xD;
      risk of receiving fragmented care leading to increased risk for avoidable illness, death, and&#xD;
      health care costs. Recent Canadian studies and reports identify significant gaps in the&#xD;
      delivery of effective care to patients with multiple chronic conditions in community-based&#xD;
      settings.&#xD;
&#xD;
      The overall goal of the intervention is to promote successful management of chronic&#xD;
      conditions, enhance quality of life, reduce the on-demand use of expensive health services&#xD;
      and support primary caregivers (i.e. family or friends) who provide physical, emotional or&#xD;
      financial care to an older adult with multimorbidity. This research program will leverage the&#xD;
      tremendous potential to reduce the burden of multimorbidity by enhancing community-based&#xD;
      prevention and chronic disease management.&#xD;
&#xD;
      This pragmatic mixed-methods randomized controlled trial will evaluate the effectiveness of&#xD;
      an interprofessional team-based self-management intervention on health-related quality of&#xD;
      life (HRQOL), depression, anxiety, self-efficacy, and the costs of use of health services for&#xD;
      older adults with multimorbidity receiving home care and their family caregivers. The results&#xD;
      will inform: (1) the development of national standards for community-based care for patients&#xD;
      with multimorbidity and (2) the development of a new and innovative community-based model for&#xD;
      the management of multimorbidity that can be scaled up and spread across Canada.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Question:&#xD;
&#xD;
      What is the acceptability and effects of a six-month self-management program compared to&#xD;
      usual home care services for older adults with multimorbidity and their family and friend&#xD;
      caregivers?&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The design is a pragmatic, mixed-methods; randomized controlled trial with individuals newly&#xD;
      referred to and using home care services. The intervention is a 6-month self-management&#xD;
      program for older adults with multimorbidity. It will be provided by an interprofessional&#xD;
      team of home care providers and will consist of three components: (1) intensive case&#xD;
      management to facilitate access to services across the care continuum, provide psychosocial&#xD;
      support and advocacy, and coordinate home care; (2) a minimum of two in-home visits by the&#xD;
      Community Care Access Centre (CCAC) Case Manager, two visits by the Registered Nurse (RN),&#xD;
      three visits by the Physiotherapist (PT) or Occupational Therapist (OT), and six visits by a&#xD;
      Personal Support Worker (PSW) over 6 months in addition to usual home care services. The&#xD;
      in-home visit schedule and team composition will be tailored to client needs and will be&#xD;
      determined in collaboration with the home care providers. The interprofessional (IP) team&#xD;
      will conduct comprehensive screening and assessments for chronic conditions, utilize&#xD;
      strengths-based practice to encourage self-management and foster behavioural change, provide&#xD;
      education for multimorbidity, medication review and management, in-home exercise, and&#xD;
      caregiver support; and (3) monthly interprofessional team case conferences to develop an IP&#xD;
      evidence-based, patient-centred care plan.&#xD;
&#xD;
      Outcomes will be assessed at baseline and 6 months. Summary descriptive measures will be&#xD;
      reported for all variables. Analysis of covariance will be used to compare study groups,&#xD;
      while adjusting for baseline measurements and potential confounding variables. Subgroup&#xD;
      analyses will be conducted based on sex/gender and region.&#xD;
&#xD;
      Expected Outcomes:&#xD;
&#xD;
      It is expected that older adults receiving the intervention will show greater improvements in&#xD;
      health-related quality of life compared to usual home care services. These improvements will&#xD;
      be achieved at no additional cost, from a societal perspective.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2)</measure>
    <time_frame>Baseline and end of study (6 months from baseline)</time_frame>
    <description>The Short-Form 12 Health Survey will be administered to older adult participants to measure health-related quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorder Screener (GAD-7) Scale</measure>
    <time_frame>Baseline and end of study (6 months from baseline)</time_frame>
    <description>The GAD-7 will be administered to older adult participants at baseline and 6 months to assess anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health and Social Services Utilization Inventory (HSSUI)</measure>
    <time_frame>Baseline and end of study (6 months from baseline)</time_frame>
    <description>The HSSUI will be administered to older adult participants at baseline and 6 months to assess healthcare utilization costs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Centre for Epidemiological Studies in Depression - Shortened version (CES-D-10)</measure>
    <time_frame>Baseline and end of study (6 months from baseline)</time_frame>
    <description>The CES-D-10 will be administered to older adult participants at baseline and 6 months to assess depressive symptoms&#xD;
It is estimated that approximately 70% of the study participants will have a family caregiver.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Collaborative Practice Assessment Tool (CPAT)</measure>
    <time_frame>At 3 months and at 9 months after the start of the study</time_frame>
    <description>The CPAT will be administered to participating home care providers at 3 months and 9 months after initiation of the intervention to assess changes in collaborative practice.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2)</measure>
    <time_frame>Baseline and end of study (6 months from baseline)</time_frame>
    <description>The Short-Form 12 Health Survey will be administered to older adult participants to measure health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy for managing chronic disease scale</measure>
    <time_frame>Baseline and end of study (6 months from baseline)</time_frame>
    <description>The self-efficacy for managing chronic disease scale will be administered to older adult participants to assess their level of self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Team Climate Inventory-19 (TCI-19)</measure>
    <time_frame>At 3 months and at 9 months after the start of the study</time_frame>
    <description>The TCI-19 will be administered to participating home care providers at 3 months and 9 months after initiation of the intervention to assess the level of team functioning.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Multimorbidity</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive usual care, which is provided by the community care access centre (CCAC). Usual care may include in-home visits by regulated health care providers, personal support workers, and care coordination through the community care access centre. Case conferences may occur on an as-needed basis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-Management Program for Older Adults with Multimorbidity</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals in the intervention group will receive a six-month self-management intervention consisting of three components: (1) intensive case management and community navigation; (2) a maximum of two in-home visits by the care coordinator, two in-home visits by a Registered Nurse, and three in-home visits by the Occupational therapist or Physiotherapist, and six visits by a Personal Support Worker over 6 months in addition to usual home care services; and (3) monthly interprofessional team case conferences to develop an evidence-based, patient-centred community reintegration plan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-Management Program for Older Adults with Multimorbidity</intervention_name>
    <description>Individuals in the intervention group will receive a six-month community intervention consisting of three components: (1) intensive case management and community navigation; (2) a maximum of two in-home visits by the care coordinator, two in-home visits by a Registered Nurse, and three in-home visits by the Occupational therapist or Physiotherapist, and six visits by a Personal Support Worker over 6 months in addition to usual home care services; and (3) monthly interprofessional team case conferences to develop an evidence-based, patient-centred community reintegration plan.</description>
    <arm_group_label>Self-Management Program for Older Adults with Multimorbidity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  65 years of age and older;&#xD;
&#xD;
          -  Three or more chronic conditions&#xD;
&#xD;
          -  Newly referred (following initiation of the study) for home care services and living&#xD;
             in the community, including supportive housing, retirement homes, and lodging homes&#xD;
             and excluding long-term care;&#xD;
&#xD;
          -  Able to speak English or have access to a translator;&#xD;
&#xD;
          -  Not planning to move away from the CCAC catchment area in the next 6 months;&#xD;
&#xD;
          -  Be mentally competent to provide informed consent, either independently or by a&#xD;
             substitute decision maker.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants will be excluded if they are unable to read and understand English and do&#xD;
             not have access to their own translator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maureen Markle-Reid, RN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University, School of Nursing</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jenny Ploeg, RN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University, School of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McMaster University</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>January 28, 2020</last_update_submitted>
  <last_update_submitted_qc>January 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Maureen Markle-Reid</investigator_full_name>
    <investigator_title>Professor and Canada Research Chair, Co-Scientific Director of Aging, Community and Health Research Unit (ACHRU)</investigator_title>
  </responsible_party>
  <keyword>Older adults</keyword>
  <keyword>Home and community care</keyword>
  <keyword>Effectiveness</keyword>
  <keyword>Cost analysis</keyword>
  <keyword>Pragmatic trial</keyword>
  <keyword>Self-management</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02209285
org study id: STRCT- 06669
nct id: NCT02209285
lead sponsor: 
has dmc: No
Patients with multimorbidity move between multiple care settings, and so they are at high
      risk of receiving fragmented care leading to increased risk for avoidable illness, death, and
      health care costs. Recent Canadian studies and reports identify significant gaps in the
      delivery of effective care to patients with multiple chronic conditions in community-based
      settings.

      The overall goal of the intervention is to promote successful management of chronic
      conditions, enhance quality of life, reduce the on-demand use of expensive health services
      and support primary caregivers (i.e. family or friends) who provide physical, emotional or
      financial care to an older adult with multimorbidity. This research program will leverage the
      tremendous potential to reduce the burden of multimorbidity by enhancing community-based
      prevention and chronic disease management.

      This pragmatic mixed-methods randomized controlled trial will evaluate the effectiveness of
      an interprofessional team-based self-management intervention on health-related quality of
      life (HRQOL), depression, anxiety, self-efficacy, and the costs of use of health services for
      older adults with multimorbidity receiving home care and their family caregivers. The results
      will inform: (1) the development of national standards for community-based care for patients
      with multimorbidity and (2) the development of a new and innovative community-based model for
      the management of multimorbidity that can be scaled up and spread across Canada.
Research Question:

      What is the acceptability and effects of a six-month self-management program compared to
      usual home care services for older adults with multimorbidity and their family and friend
      caregivers?

      Methods:

      The design is a pragmatic, mixed-methods; randomized controlled trial with individuals newly
      referred to and using home care services. The intervention is a 6-month self-management
      program for older adults with multimorbidity. It will be provided by an interprofessional
      team of home care providers and will consist of three components: (1) intensive case
      management to facilitate access to services across the care continuum, provide psychosocial
      support and advocacy, and coordinate home care; (2) a minimum of two in-home visits by the
      Community Care Access Centre (CCAC) Case Manager, two visits by the Registered Nurse (RN),
      three visits by the Physiotherapist (PT) or Occupational Therapist (OT), and six visits by a
      Personal Support Worker (PSW) over 6 months in addition to usual home care services. The
      in-home visit schedule and team composition will be tailored to client needs and will be
      determined in collaboration with the home care providers. The interprofessional (IP) team
      will conduct comprehensive screening and assessments for chronic conditions, utilize
      strengths-based practice to encourage self-management and foster behavioural change, provide
      education for multimorbidity, medication review and management, in-home exercise, and
      caregiver support; and (3) monthly interprofessional team case conferences to develop an IP
      evidence-based, patient-centred care plan.

      Outcomes will be assessed at baseline and 6 months. Summary descriptive measures will be
      reported for all variables. Analysis of covariance will be used to compare study groups,
      while adjusting for baseline measurements and potential confounding variables. Subgroup
      analyses will be conducted based on sex/gender and region.

      Expected Outcomes:

      It is expected that older adults receiving the intervention will show greater improvements in
      health-related quality of life compared to usual home care services. These improvements will
      be achieved at no additional cost, from a societal perspective.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Physical Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2)
time frame: Baseline and end of study (6 months from baseline)
description: The Short-Form 12 Health Survey will be administered to older adult participants to measure health-related quality of life.
measure: Generalized Anxiety Disorder Screener (GAD-7) Scale
time frame: Baseline and end of study (6 months from baseline)
description: The GAD-7 will be administered to older adult participants at baseline and 6 months to assess anxiety.
measure: Health and Social Services Utilization Inventory (HSSUI)
time frame: Baseline and end of study (6 months from baseline)
description: The HSSUI will be administered to older adult participants at baseline and 6 months to assess healthcare utilization costs.
measure: Centre for Epidemiological Studies in Depression - Shortened version (CES-D-10)
time frame: Baseline and end of study (6 months from baseline)
description: The CES-D-10 will be administered to older adult participants at baseline and 6 months to assess depressive symptoms
It is estimated that approximately 70% of the study participants will have a family caregiver.
measure: Collaborative Practice Assessment Tool (CPAT)
time frame: At 3 months and at 9 months after the start of the study
description: The CPAT will be administered to participating home care providers at 3 months and 9 months after initiation of the intervention to assess changes in collaborative practice.
measure: Mental Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2)
time frame: Baseline and end of study (6 months from baseline)
description: The Short-Form 12 Health Survey will be administered to older adult participants to measure health-related quality of life.
measure: Self-efficacy for managing chronic disease scale
time frame: Baseline and end of study (6 months from baseline)
description: The self-efficacy for managing chronic disease scale will be administered to older adult participants to assess their level of self-efficacy
measure: Team Climate Inventory-19 (TCI-19)
time frame: At 3 months and at 9 months after the start of the study
description: The TCI-19 will be administered to participating home care providers at 3 months and 9 months after initiation of the intervention to assess the level of team functioning.
arm group label: Control group
arm group type: No Intervention
description: The control group will receive usual care, which is provided by the community care access centre (CCAC). Usual care may include in-home visits by regulated health care providers, personal support workers, and care coordination through the community care access centre. Case conferences may occur on an as-needed basis.
arm group label: Self-Management Program for Older Adults with Multimorbidity
arm group type: Active Comparator
description: Individuals in the intervention group will receive a six-month self-management intervention consisting of three components: (1) intensive case management and community navigation; (2) a maximum of two in-home visits by the care coordinator, two in-home visits by a Registered Nurse, and three in-home visits by the Occupational therapist or Physiotherapist, and six visits by a Personal Support Worker over 6 months in addition to usual home care services; and (3) monthly interprofessional team case conferences to develop an evidence-based, patient-centred community reintegration plan.
intervention type: Behavioral
intervention name: Self-Management Program for Older Adults with Multimorbidity
description: Individuals in the intervention group will receive a six-month community intervention consisting of three components: (1) intensive case management and community navigation; (2) a maximum of two in-home visits by the care coordinator, two in-home visits by a Registered Nurse, and three in-home visits by the Occupational therapist or Physiotherapist, and six visits by a Personal Support Worker over 6 months in addition to usual home care services; and (3) monthly interprofessional team case conferences to develop an evidence-based, patient-centred community reintegration plan.
arm group label: Self-Management Program for Older Adults with Multimorbidity
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Maureen Markle-Reid, RN, PhD
role: Principal Investigator
affiliation: McMaster University, School of Nursing
last name: Jenny Ploeg, RN, PhD
role: Principal Investigator
affiliation: McMaster University, School of Nursing
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Maureen Markle-Reid
investigator title: Professor and Canada Research Chair, Co-Scientific Director of Aging, Community and Health Research Unit (ACHRU)
sharing ipd: No