Do Educational Digital Films Enhance Patient COPD Outcomes?
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pocket Medic
Pulmonary Rehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- Eligible for pulmonary rehabilitation in Hywel Dda University Health Board.
Exclusion Criteria:
- Unwilling or unable to give informed consent
- life expectancy of less than 6 months
- unstable cardiovascular disease, dementia, cancers other than non-melanoma skins cancer
- any condition that precludes patients using laptops or mobile phones (e.g. blind, deaf)
Sites / Locations
- Glangwilli Hospital
- Prince Phillip Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
Patient engagement
The level at which patients in the intervention arm watch the digital films
Patient Adherence
The level at which patients attend pulmonary rehabilitation sessions
Secondary Outcome Measures
Disease Knowledge
Scores on Bristol COPD Knowledge Questionnaire
Service Utilization
Number of General Practioner visits and hospitalizations
Psychological self-management
Patient scores on self-determination theory questionnaires modified to be relevant to COPD
Understanding COPD self-management
Scores on the Understanding COPD self-management questionnaire
Full Information
NCT ID
NCT03263754
First Posted
August 24, 2017
Last Updated
January 10, 2019
Sponsor
Aberystwyth University
Collaborators
Hywel Dda Health Board
1. Study Identification
Unique Protocol Identification Number
NCT03263754
Brief Title
Do Educational Digital Films Enhance Patient COPD Outcomes?
Official Title
Do Patients With Chronic Obstructive Pulmonary Disease Engaging With Educational Films in Addition to Pulmonary Rehabilitation Gain Health-related Improvements?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aberystwyth University
Collaborators
Hywel Dda Health Board
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to assess the efficacy of Pocket Medic to promote self-management and pulmonary rehabilitation adherence in COPD patients.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Pocket Medic
Intervention Description
10 short digital films utilising self-determination theory aiming to increase patient self-management
Intervention Type
Behavioral
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
PR follows National Institute for Clinical Excellence guidelines delivering 14 sessions over 7 weeks utilising a multidisciplinary approach
Primary Outcome Measure Information:
Title
Patient engagement
Description
The level at which patients in the intervention arm watch the digital films
Time Frame
10 weeks
Title
Patient Adherence
Description
The level at which patients attend pulmonary rehabilitation sessions
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Disease Knowledge
Description
Scores on Bristol COPD Knowledge Questionnaire
Time Frame
10 weeks and 6 months
Title
Service Utilization
Description
Number of General Practioner visits and hospitalizations
Time Frame
Baseline and 6 months
Title
Psychological self-management
Description
Patient scores on self-determination theory questionnaires modified to be relevant to COPD
Time Frame
10 weeks and 6 months
Title
Understanding COPD self-management
Description
Scores on the Understanding COPD self-management questionnaire
Time Frame
10 weeks and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible for pulmonary rehabilitation in Hywel Dda University Health Board.
Exclusion Criteria:
Unwilling or unable to give informed consent
life expectancy of less than 6 months
unstable cardiovascular disease, dementia, cancers other than non-melanoma skins cancer
any condition that precludes patients using laptops or mobile phones (e.g. blind, deaf)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liam Knox
Organizational Affiliation
Aberystwyth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glangwilli Hospital
City
Carmarthen
State/Province
Carmarthenshire
ZIP/Postal Code
SA31 2AF
Country
United Kingdom
Facility Name
Prince Phillip Hospital
City
Llanelli
State/Province
Carmarthenshire
ZIP/Postal Code
SA14 8QF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Do Educational Digital Films Enhance Patient COPD Outcomes?
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