<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/NCT03263754</url>
  </required_header>
  <id_info>
    <org_study_id>10203918b3002e6f1be4a19987</org_study_id>
    <nct_id>NCT03263754</nct_id>
  </id_info>
  <brief_title>Do Educational Digital Films Enhance Patient COPD Outcomes?</brief_title>
  <official_title>Do Patients With Chronic Obstructive Pulmonary Disease Engaging With Educational Films in Addition to Pulmonary Rehabilitation Gain Health-related Improvements?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aberystwyth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hywel Dda Health Board</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aberystwyth University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study aims to assess the efficacy of Pocket Medic to promote self-management and&#xD;
      pulmonary rehabilitation adherence in COPD patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic Obstructive Pulmonary Disease (COPD) refers to a group of lung conditions&#xD;
      characterized by airways inflammation, small airways obstruction and progressive loss of lung&#xD;
      function. There are 900,000 people diagnosed with COPD in England and Wales but allowing for&#xD;
      under-diagnosis, the true prevalence could be 1.5 million. Sufferers are extensive health&#xD;
      care users; where COPD is the second most common cause of emergency hospital admission in the&#xD;
      United Kingdom with direct National Health Service costs over £800 million per year.&#xD;
      Pulmonary Rehabilitation programs (PRPs) aim to provide education and support for patients&#xD;
      whilst improving clinical outcomes, however, attendance to these programs can be low.&#xD;
&#xD;
      This study aims to trial a series of digital films aimed at educating patients about their&#xD;
      condition from the comfort of their own home. Approximately 80 patients eligible for PR will&#xD;
      be allocated to an experimental condition to receive a series of 10 digital films alongside&#xD;
      their standard 7-week PR, solely to receive 10 digital films, or to a control condition in&#xD;
      the form of standard PR (no digital films). Outcome measures such as PR attendance, hospital&#xD;
      admissions, quality of life (QoL), disease knowledge, psychological need satisfaction and&#xD;
      motivation will be measured pre and post. Analysis of this data between the experimental and&#xD;
      control conditions pre-post intervention will provide useful information regarding the&#xD;
      efficacy of digital film prescriptions as an adjunct to usual PR, or on its own, and the role&#xD;
      this may play is encouraging PR attendance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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>Patient engagement</measure>
    <time_frame>10 weeks</time_frame>
    <description>The level at which patients in the intervention arm watch the digital films</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Adherence</measure>
    <time_frame>10 weeks</time_frame>
    <description>The level at which patients attend pulmonary rehabilitation sessions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease Knowledge</measure>
    <time_frame>10 weeks and 6 months</time_frame>
    <description>Scores on Bristol COPD Knowledge Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Service Utilization</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Number of General Practioner visits and hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological self-management</measure>
    <time_frame>10 weeks and 6 months</time_frame>
    <description>Patient scores on self-determination theory questionnaires modified to be relevant to COPD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Understanding COPD self-management</measure>
    <time_frame>10 weeks and 6 months</time_frame>
    <description>Scores on the Understanding COPD self-management questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pocket Medic</intervention_name>
    <description>10 short digital films utilising self-determination theory aiming to increase patient self-management</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pulmonary Rehabilitation</intervention_name>
    <description>PR follows National Institute for Clinical Excellence guidelines delivering 14 sessions over 7 weeks utilising a multidisciplinary approach</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible for pulmonary rehabilitation in Hywel Dda University Health Board.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling or unable to give informed consent&#xD;
&#xD;
          -  life expectancy of less than 6 months&#xD;
&#xD;
          -  unstable cardiovascular disease, dementia, cancers other than non-melanoma skins&#xD;
             cancer&#xD;
&#xD;
          -  any condition that precludes patients using laptops or mobile phones (e.g. blind,&#xD;
             deaf)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liam Knox</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aberystwyth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Glangwilli Hospital</name>
      <address>
        <city>Carmarthen</city>
        <state>Carmarthenshire</state>
        <zip>SA31 2AF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince Phillip Hospital</name>
      <address>
        <city>Llanelli</city>
        <state>Carmarthenshire</state>
        <zip>SA14 8QF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 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>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT03263754
org study id: 10203918b3002e6f1be4a19987
nct id: NCT03263754
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to assess the efficacy of Pocket Medic to promote self-management and
      pulmonary rehabilitation adherence in COPD patients.
Chronic Obstructive Pulmonary Disease (COPD) refers to a group of lung conditions
      characterized by airways inflammation, small airways obstruction and progressive loss of lung
      function. There are 900,000 people diagnosed with COPD in England and Wales but allowing for
      under-diagnosis, the true prevalence could be 1.5 million. Sufferers are extensive health
      care users; where COPD is the second most common cause of emergency hospital admission in the
      United Kingdom with direct National Health Service costs over £800 million per year.
      Pulmonary Rehabilitation programs (PRPs) aim to provide education and support for patients
      whilst improving clinical outcomes, however, attendance to these programs can be low.

      This study aims to trial a series of digital films aimed at educating patients about their
      condition from the comfort of their own home. Approximately 80 patients eligible for PR will
      be allocated to an experimental condition to receive a series of 10 digital films alongside
      their standard 7-week PR, solely to receive 10 digital films, or to a control condition in
      the form of standard PR (no digital films). Outcome measures such as PR attendance, hospital
      admissions, quality of life (QoL), disease knowledge, psychological need satisfaction and
      motivation will be measured pre and post. Analysis of this data between the experimental and
      control conditions pre-post intervention will provide useful information regarding the
      efficacy of digital film prescriptions as an adjunct to usual PR, or on its own, and the role
      this may play is encouraging PR attendance.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient engagement
time frame: 10 weeks
description: The level at which patients in the intervention arm watch the digital films
measure: Patient Adherence
time frame: 10 weeks
description: The level at which patients attend pulmonary rehabilitation sessions
measure: Disease Knowledge
time frame: 10 weeks and 6 months
description: Scores on Bristol COPD Knowledge Questionnaire
measure: Service Utilization
time frame: Baseline and 6 months
description: Number of General Practioner visits and hospitalizations
measure: Psychological self-management
time frame: 10 weeks and 6 months
description: Patient scores on self-determination theory questionnaires modified to be relevant to COPD
measure: Understanding COPD self-management
time frame: 10 weeks and 6 months
description: Scores on the Understanding COPD self-management questionnaire
arm group label: Intervention
arm group type: Experimental
arm group label: Control
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Pocket Medic
description: 10 short digital films utilising self-determination theory aiming to increase patient self-management
arm group label: Intervention
intervention type: Behavioral
intervention name: Pulmonary Rehabilitation
description: PR follows National Institute for Clinical Excellence guidelines delivering 14 sessions over 7 weeks utilising a multidisciplinary approach
arm group label: Control
arm group label: Intervention
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Liam Knox
role: Principal Investigator
affiliation: Aberystwyth University
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No