Do Educational Digital Films Enhance Patient COPD Outcomes?

Do Patients With Chronic Obstructive Pulmonary Disease Engaging With Educational Films in Addition to Pulmonary Rehabilitation Gain Health-related Improvements?

This study aims to assess the efficacy of Pocket Medic to promote self-management and pulmonary rehabilitation adherence in COPD patients.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: Pocket Medic; Behavioral: Pulmonary Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Carmarthenshire
    • Carmarthen, Carmarthenshire, United Kingdom, SA31 2AF
      • Glangwilli Hospital
    • Llanelli, Carmarthenshire, United Kingdom, SA14 8QF
      • Prince Phillip Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: Pocket Medic; 10 short digital films utilising self-determination theory aiming to increase patient self-management; Behavioral: Pulmonary Rehabilitation; PR follows National Institute for Clinical Excellence guidelines delivering 14 sessions over 7 weeks utilising a multidisciplinary approach
Active Comparator: Control	Behavioral: Pulmonary Rehabilitation; PR follows National Institute for Clinical Excellence guidelines delivering 14 sessions over 7 weeks utilising a multidisciplinary approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient engagement	The level at which patients in the intervention arm watch the digital films	10 weeks
Patient Adherence	The level at which patients attend pulmonary rehabilitation sessions	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Knowledge	Scores on Bristol COPD Knowledge Questionnaire	10 weeks and 6 months
Service Utilization	Number of General Practioner visits and hospitalizations	Baseline and 6 months
Psychological self-management	Patient scores on self-determination theory questionnaires modified to be relevant to COPD	10 weeks and 6 months
Understanding COPD self-management	Scores on the Understanding COPD self-management questionnaire	10 weeks and 6 months

Collaborators and Investigators

• Sponsor: Aberystwyth University
• Collaborators: Hywel Dda Health Board
• Investigators: Principal Investigator: Liam Knox, Aberystwyth University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 10203918b3002e6f1be4a19987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No