<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/NCT03300583</url>
  </required_header>
  <id_info>
    <org_study_id>16.0151</org_study_id>
    <nct_id>NCT03300583</nct_id>
  </id_info>
  <brief_title>Toward Self-management in ILD</brief_title>
  <official_title>Toward a Model of Self-management; Identifying Gaps and Needs in Services for Patients With Interstitial Lung Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kingston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. George's Hospital, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University College London Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kingston University</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>
      Treating and caring for people with long term conditions accounts for a substantial&#xD;
      proportion of health care resources. Self-management is advocated as a mechanism that can&#xD;
      empower service users with long term conditions to choose healthier options and also&#xD;
      transform the relationship between service user and caregivers from one in which the former&#xD;
      is a passive recipient of care to one in which they are an active partner in decision-making.&#xD;
&#xD;
      Interstitial lung disease (ILD) is one such long term condition. Patients with ILD often&#xD;
      express concern about the lack of information on possible rehabilitation programmes and other&#xD;
      services that could potentially improve self-management of the disease. In addition, there is&#xD;
      a general perception about a lack of co-ordination between health care professionals&#xD;
      especially in relation to referral to services for comprehensive management of the disease.&#xD;
      Therefore, the needs of patients with ILD and their carers, and possible gaps in service&#xD;
      provision need to be explored further.&#xD;
&#xD;
      In this study, the investigators propose to explore the needs of ILD patients from all types&#xD;
      of ILD and all stages of severity and to also involve carers and clinicians. The&#xD;
      investigators will conduct three focus groups for patients and carers and six one-to-one&#xD;
      interviews with clinicians to explore perceptions about service gaps and needs in two ILD&#xD;
      centres in South and North London, UK.&#xD;
&#xD;
      This study will provide valuable information to develop the building blocks of a&#xD;
      self-management resource and will enable the investigators to make it specific to the&#xD;
      different types of ILD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Perceptions of service needs and gaps in current services among ILD patients, carers and clinicians</measure>
    <time_frame>1-2 hours</time_frame>
    <description>Exploratory method, conducted using semi-structured 1:1 interviews and focus groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in perceptions between participating ILD patients, carers and clinicians</measure>
    <time_frame>1-2 hours</time_frame>
    <description>Exploratory method, conducted using semi-structured interviews and focus groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presentation and explanation of diagnosis and its implications to ILD patients and carers</measure>
    <time_frame>1-2 hours</time_frame>
    <description>Exploratory method using semi-structured interviews and focus groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presentation and explanation of information about the management of the disease to ILD patients and carers</measure>
    <time_frame>1-2 hours</time_frame>
    <description>Exploratory method using semi-structured interviews and focus groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recommended solutions for better self-management</measure>
    <time_frame>1-2 hours</time_frame>
    <description>Exploratory method using semi-structured interviews and focus groups</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Interstitial Lung Disease</condition>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <condition>Connective Tissue Related ILD</condition>
  <condition>Chronic Hypersensitivity Pneumonitis</condition>
  <condition>Fibrotic Lung Disease</condition>
  <arm_group>
    <arm_group_label>ILD patients</arm_group_label>
    <description>Patients from all types of ILD who are under the care of the two collaborating hospitals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Family/Carers</arm_group_label>
    <description>Family and carers of patients with ILD who are or have been treated in the two collaborating hospitals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinicians</arm_group_label>
    <description>Clinicians from the two collaborating hospitals and GPs from the nearby areas who treat and refer patients with ILD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Focus groups</intervention_name>
    <description>Focus group discussion led by the PI and facilitated by another researcher.</description>
    <arm_group_label>Family/Carers</arm_group_label>
    <arm_group_label>ILD patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Semi-structured interviews</intervention_name>
    <description>1:1 semi-structured interviews led by the PI</description>
    <arm_group_label>Clinicians</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Interstitial Lung disease (ILD), their carers and healthcare professionals&#xD;
        involved in their care in two hospitals in South and North London, UK.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        PATIENTS&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with Interstitial Lung disease (all types apart from sarcoidosis)&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  At least one consultation with a health care professional&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with sarcoidosis&#xD;
&#xD;
          -  Unable to communicate in English&#xD;
&#xD;
          -  Severity of condition and commodities preventing participation&#xD;
&#xD;
        CAREGIVERS&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        - Currently caring for a participant with ILD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Unable to communicate in English&#xD;
&#xD;
        CLINICIANS:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        - Involved in the clinical management and treatment of ILD patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Health care professionals not directly involved in management or treatment of ILD&#xD;
        patients&#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>
  <overall_official>
    <last_name>Dimitra Nikoletou, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kingston University and St George's University of London- Joint Faculty- Health, Social care and Education</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St George's Hospital London</name>
      <address>
        <city>London</city>
        <zip>SW17 ORE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>February 18, 2021</last_update_submitted>
  <last_update_submitted_qc>February 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kingston University</investigator_affiliation>
    <investigator_full_name>Dimitra Nikoletou</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Interstitial lung disease</keyword>
  <keyword>Self-Management</keyword>
  <keyword>Service provision</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</mesh_term>
    <mesh_term>Alveolitis, Extrinsic Allergic</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>A unique identification number will be allocated to each participant and data will not be shared without being anonymised</ipd_description>
  </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/NCT03300583
org study id: 16.0151
nct id: NCT03300583
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Treating and caring for people with long term conditions accounts for a substantial
      proportion of health care resources. Self-management is advocated as a mechanism that can
      empower service users with long term conditions to choose healthier options and also
      transform the relationship between service user and caregivers from one in which the former
      is a passive recipient of care to one in which they are an active partner in decision-making.

      Interstitial lung disease (ILD) is one such long term condition. Patients with ILD often
      express concern about the lack of information on possible rehabilitation programmes and other
      services that could potentially improve self-management of the disease. In addition, there is
      a general perception about a lack of co-ordination between health care professionals
      especially in relation to referral to services for comprehensive management of the disease.
      Therefore, the needs of patients with ILD and their carers, and possible gaps in service
      provision need to be explored further.

      In this study, the investigators propose to explore the needs of ILD patients from all types
      of ILD and all stages of severity and to also involve carers and clinicians. The
      investigators will conduct three focus groups for patients and carers and six one-to-one
      interviews with clinicians to explore perceptions about service gaps and needs in two ILD
      centres in South and North London, UK.

      This study will provide valuable information to develop the building blocks of a
      self-management resource and will enable the investigators to make it specific to the
      different types of ILD.
observational model: Cohort
time perspective: Prospective
measure: Perceptions of service needs and gaps in current services among ILD patients, carers and clinicians
time frame: 1-2 hours
description: Exploratory method, conducted using semi-structured 1:1 interviews and focus groups
measure: Differences in perceptions between participating ILD patients, carers and clinicians
time frame: 1-2 hours
description: Exploratory method, conducted using semi-structured interviews and focus groups
measure: Presentation and explanation of diagnosis and its implications to ILD patients and carers
time frame: 1-2 hours
description: Exploratory method using semi-structured interviews and focus groups
measure: Presentation and explanation of information about the management of the disease to ILD patients and carers
time frame: 1-2 hours
description: Exploratory method using semi-structured interviews and focus groups
measure: Recommended solutions for better self-management
time frame: 1-2 hours
description: Exploratory method using semi-structured interviews and focus groups
arm group label: ILD patients
description: Patients from all types of ILD who are under the care of the two collaborating hospitals.
arm group label: Family/Carers
description: Family and carers of patients with ILD who are or have been treated in the two collaborating hospitals.
arm group label: Clinicians
description: Clinicians from the two collaborating hospitals and GPs from the nearby areas who treat and refer patients with ILD.
intervention type: Behavioral
intervention name: Focus groups
description: Focus group discussion led by the PI and facilitated by another researcher.
arm group label: Family/Carers
arm group label: ILD patients
intervention type: Behavioral
intervention name: Semi-structured interviews
description: 1:1 semi-structured interviews led by the PI
arm group label: Clinicians
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dimitra Nikoletou, PhD
role: Principal Investigator
affiliation: Kingston University and St George's University of London- Joint Faculty- Health, Social care and Education
facility: 
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Kingston University
investigator full name: Dimitra Nikoletou
investigator title: Associate Professor
mesh term: Pneumonia
mesh term: Lung Diseases
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Lung Diseases, Interstitial
mesh term: Alveolitis, Extrinsic Allergic
mesh term: Hypersensitivity
sharing ipd: No
ipd description: A unique identification number will be allocated to each participant and data will not be shared without being anonymised