Clinical trial NCT03263754: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Aberystwyth University
Sponsor class: OTHER
Collaborators: name: Hywel Dda Health Board
First posted: 2017-08-28
Enrollment: 55
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Patient engagement
timeFrame: 10 weeks
measure: Patient Adherence
timeFrame: 10 weeks
Secondary outcomes:
measure: Disease Knowledge
timeFrame: 10 weeks and 6 months
measure: Service Utilization
timeFrame: Baseline and 6 months
measure: Psychological self-management
timeFrame: 10 weeks and 6 months
measure: Understanding COPD self-management
timeFrame: 10 weeks and 6 months
Other outcomes:
Locations:
city: Carmarthen
country: United Kingdom
facility: Glangwilli Hospital
state: Carmarthenshire
city: Llanelli
country: United Kingdom
facility: Prince Phillip Hospital
state: Carmarthenshire
Study officials:
affiliation: Aberystwyth University
name: Liam Knox
role: PRINCIPAL_INVESTIGATOR
References: