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CompletedNCT03263754Updated Jan 11, 2019

Do Educational Digital Films Enhance Patient COPD Outcomes?

An interventional study of Pocket Medic and Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease, sponsored by Aberystwyth University. Completed at 2 sites in United Kingdom. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-01-11.

Sponsored by Aberystwyth University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Eligible for pulmonary rehabilitation in Hywel Dda University Health Board.

Exclusion criteria

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)
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Intervention

    Behavioral: Pocket Medic · Behavioral: Pulmonary Rehabilitation

  • Active comparator
    Control

    Behavioral: Pulmonary Rehabilitation

Interventions

  • BehavioralPocket Medic

    10 short digital films utilising self-determination theory aiming to increase patient self-management

  • BehavioralPulmonary Rehabilitation

    PR follows National Institute for Clinical Excellence guidelines delivering 14 sessions over 7 weeks utilising a multidisciplinary approach

05

What researchers measure

Primary outcomes

  1. Patient engagement

    The level at which patients in the intervention arm watch the digital films

    Time frame: 10 weeks

  2. Patient Adherence

    The level at which patients attend pulmonary rehabilitation sessions

    Time frame: 10 weeks

Secondary outcomes

  1. Disease Knowledge

    Scores on Bristol COPD Knowledge Questionnaire

    Time frame: 10 weeks and 6 months

  2. Service Utilization

    Number of General Practioner visits and hospitalizations

    Time frame: Baseline and 6 months

  3. Psychological self-management

    Patient scores on self-determination theory questionnaires modified to be relevant to COPD

    Time frame: 10 weeks and 6 months

  4. Understanding COPD self-management

    Scores on the Understanding COPD self-management questionnaire

    Time frame: 10 weeks and 6 months

06

Study locations

2 sites
  • Glangwilli Hospital
    Carmarthen, Carmarthenshire SA31 2AF, United Kingdom
  • Prince Phillip Hospital
    Llanelli, Carmarthenshire SA14 8QF, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03263754
Lead sponsor
Aberystwyth University
Collaborators
Hywel Dda Health Board
Responsible party
Sponsor
First posted
Aug 28, 2017
Start date
Sep 1, 2016
Primary completion
Jul 2018
Completion
Jul 2018
Last update
Jan 11, 2019

Study contacts

Liam Knox
principal investigator · Aberystwyth University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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