<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/NCT03262428</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0480</org_study_id>
    <nct_id>NCT03262428</nct_id>
  </id_info>
  <brief_title>Collaborative Self-Management Support in Chronic Conditions - Qualitative Study</brief_title>
  <acronym>CoSMaS-ql</acronym>
  <official_title>Collaborative Self-Management Support in Chronic Conditions: a Qualitative Study of Patients', Caregivers' and Health Care Professionals' Views and Experiences of Integrated Care in Asthma, Breast Cancer and Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The management of chronic conditions is a challenge for health systems worldwide,&#xD;
      particularly in the context of an aging population, and requires urgent improvement of health&#xD;
      services. Integrated care and patient empowerment represent promising solutions: offering&#xD;
      tailored self-management support in a collaborative framework led to good results in several&#xD;
      clinical contexts. Yet, large scale implementation remains a challenge. An important&#xD;
      limitation of existing solutions is a lack of utilization of behavioural and communication&#xD;
      theory for identifying the dynamics of pluridisciplinary collaboration and the interactive&#xD;
      effects of the activities performed by several actors involved in self-management support in&#xD;
      a given chronic condition. A second limitation is not involving all relevant actors in the&#xD;
      development of health service improvement solutions, which leads to limited programme&#xD;
      adoption and sustainability in routine care.&#xD;
&#xD;
      This study is part of a project that proposes to address these limitations and develop and&#xD;
      interdisciplinary model of collaborative care in the self-management of chronic conditions&#xD;
      (CoSMaS) that adopts a community-based participative approach. CoSMaS-ql is a qualitative&#xD;
      study that will consist of semi-structured interviews with several types of stakeholders:&#xD;
      patients, caregivers, and health care professionals of different specialties (e.g. general&#xD;
      practitioners, nurses, specialist consultants, pharmacists). The main objective of the study&#xD;
      is to explore the experiences and of patients, caregivers, and HCPs on how self-management&#xD;
      support is currently delivered in asthma, cancer and stroke (content, communication,&#xD;
      organisation of care), their needs related to self-management support provision, and&#xD;
      envisaged solutions for improving current practice. Three different chronic conditions will&#xD;
      be targeted: asthma, breast cancer and stroke. The qualitative data will be analysed via&#xD;
      grounded-theory and template analysis. It will inform the development of a theoretical model&#xD;
      of collaborative self-management support in chronic conditions. It will also result in three&#xD;
      profiles describing 'real' versus 'ideal' care processes, which will represent needs&#xD;
      assessment stages for future health services improvement interventions in the three&#xD;
      conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 14, 2018</start_date>
  <completion_date type="Actual">June 27, 2019</completion_date>
  <primary_completion_date type="Actual">June 27, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Experiences and views of patients, caregivers, and health care professionals involved in the long-term management of asthma, cancer and stroke about real and ideal practices in collaborative self-management support.</measure>
    <time_frame>About 60 minutes</time_frame>
    <description>Interviews will be semi-structured and follow a topic guide designed to explore participants' goals, behaviours and determinants, perceptions of others' goals and behaviours, communication processes, tools used in self-management, support, and communication, and their vision on optimal processes and ways to implement them. Caregivers will be interviewed separately on their experiences of caregiving and self-management support by HCPs. HCPs will be interviewed regarding their experiences of providing care in one or more of the 3 chronic conditions (depending on their experience and time constraints) and their thoughts on collaborating with other professionals and solutions for integrated care and ensuring continuity of care.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">109</enrollment>
  <condition>Asthma</condition>
  <condition>Breast Cancer</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Patients with asthma, breast cancer, and stroke living in the Rhône Alpes region</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregivers</arm_group_label>
    <description>Caregivers of patients with asthma, breast cancer, and stroke living in the Rhône Alpes region</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health care professionals</arm_group_label>
    <description>Health care professionals involved in the care of patients with asthma, breast cancer, and stroke living in the Rhône Alpes region</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Semi-structured interviews</intervention_name>
    <description>Patients, caregivers and health care professionals involved in self-management support will be sought via patient organizations and professional organizations in the region. Study information materials will be provided to these organizations for dissemination to their members, providing also contact details of the study team for interested individuals to register their interest and provide basic eligibility and screening information. Selected participants will be invited to take part in a face-to-face or telephone interview about (supporting) self-management. Data collection will consist of semi-structured interviews conducted either face-to-face or by telephone.</description>
    <arm_group_label>Caregivers</arm_group_label>
    <arm_group_label>Health care professionals</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The participants will be patients, caregivers and health care professionals in the Rhône&#xD;
        Alpes region involved in self-management support in cancer, asthma or stroke.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        PATIENTS&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  having (had) one of the health conditions targeted.&#xD;
&#xD;
          -  age &gt;18 years (in order to have had the opportunity to achieve full transition from&#xD;
             parent/caregiver-managed to self-managed care),&#xD;
&#xD;
          -  at least 1 year since diagnosis (in order to have had sufficient time to experience&#xD;
             adjustments to their condition on the long term), and&#xD;
&#xD;
          -  at least 1 consultation with an HCP of any specialty in the past year (in order to&#xD;
             ensure minimum 1 recent experience of care they could reflect on).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to communicate in French&#xD;
&#xD;
          -  level of severity of health condition or comorbidities making participation in the&#xD;
             study too burdensome&#xD;
&#xD;
        CAREGIVERS:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        - nominated by a participating patients as principal caregiver&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - none&#xD;
&#xD;
        HEALTH CARE PROFESSIONALS :&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        - at least 1 year of experience working in one of the 3 chronic conditions targeted&#xD;
        (irrespective of the number of patients consulted)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>EA 7425 HESPER - Health Services and Performance Research, Université Claude Bernard Lyon 1</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 29, 2019</last_update_submitted>
  <last_update_submitted_qc>August 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <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/NCT03262428
org study id: 69HCL17_0480
nct id: NCT03262428
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The management of chronic conditions is a challenge for health systems worldwide,
      particularly in the context of an aging population, and requires urgent improvement of health
      services. Integrated care and patient empowerment represent promising solutions: offering
      tailored self-management support in a collaborative framework led to good results in several
      clinical contexts. Yet, large scale implementation remains a challenge. An important
      limitation of existing solutions is a lack of utilization of behavioural and communication
      theory for identifying the dynamics of pluridisciplinary collaboration and the interactive
      effects of the activities performed by several actors involved in self-management support in
      a given chronic condition. A second limitation is not involving all relevant actors in the
      development of health service improvement solutions, which leads to limited programme
      adoption and sustainability in routine care.

      This study is part of a project that proposes to address these limitations and develop and
      interdisciplinary model of collaborative care in the self-management of chronic conditions
      (CoSMaS) that adopts a community-based participative approach. CoSMaS-ql is a qualitative
      study that will consist of semi-structured interviews with several types of stakeholders:
      patients, caregivers, and health care professionals of different specialties (e.g. general
      practitioners, nurses, specialist consultants, pharmacists). The main objective of the study
      is to explore the experiences and of patients, caregivers, and HCPs on how self-management
      support is currently delivered in asthma, cancer and stroke (content, communication,
      organisation of care), their needs related to self-management support provision, and
      envisaged solutions for improving current practice. Three different chronic conditions will
      be targeted: asthma, breast cancer and stroke. The qualitative data will be analysed via
      grounded-theory and template analysis. It will inform the development of a theoretical model
      of collaborative self-management support in chronic conditions. It will also result in three
      profiles describing 'real' versus 'ideal' care processes, which will represent needs
      assessment stages for future health services improvement interventions in the three
      conditions.
observational model: Other
time perspective: Prospective
measure: Experiences and views of patients, caregivers, and health care professionals involved in the long-term management of asthma, cancer and stroke about real and ideal practices in collaborative self-management support.
time frame: About 60 minutes
description: Interviews will be semi-structured and follow a topic guide designed to explore participants' goals, behaviours and determinants, perceptions of others' goals and behaviours, communication processes, tools used in self-management, support, and communication, and their vision on optimal processes and ways to implement them. Caregivers will be interviewed separately on their experiences of caregiving and self-management support by HCPs. HCPs will be interviewed regarding their experiences of providing care in one or more of the 3 chronic conditions (depending on their experience and time constraints) and their thoughts on collaborating with other professionals and solutions for integrated care and ensuring continuity of care.
arm group label: Patients
description: Patients with asthma, breast cancer, and stroke living in the Rhône Alpes region
arm group label: Caregivers
description: Caregivers of patients with asthma, breast cancer, and stroke living in the Rhône Alpes region
arm group label: Health care professionals
description: Health care professionals involved in the care of patients with asthma, breast cancer, and stroke living in the Rhône Alpes region
intervention type: Other
intervention name: Semi-structured interviews
description: Patients, caregivers and health care professionals involved in self-management support will be sought via patient organizations and professional organizations in the region. Study information materials will be provided to these organizations for dissemination to their members, providing also contact details of the study team for interested individuals to register their interest and provide basic eligibility and screening information. Selected participants will be invited to take part in a face-to-face or telephone interview about (supporting) self-management. Data collection will consist of semi-structured interviews conducted either face-to-face or by telephone.
arm group label: Caregivers
arm group label: Health care professionals
arm group label: Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Asthma
mesh term: Chronic Disease
sharing ipd: No