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OpenTrials
Completed

NCT Number: NCT03263754

Do Educational Digital Films Enhance Patient COPD Outcomes?

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glangwilli Hospital, Carmarthen, Carmarthenshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pocket Medic

Behavioral

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

Pulmonary rehabilitation

Behavioral

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

Primary outcomes

  1. Patient engagement

    Time frame: 10 weeks

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

  2. Patient Adherence

    Time frame: 10 weeks

    The level at which patients attend pulmonary rehabilitation sessions

Secondary outcomes

  1. Disease Knowledge

    Time frame: 10 weeks and 6 months

    Scores on Bristol COPD Knowledge Questionnaire

  2. Service Utilization

    Time frame: Baseline and 6 months

    Number of General Practioner visits and hospitalizations

  3. Psychological self-management

    Time frame: 10 weeks and 6 months

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

  4. Understanding COPD self-management

    Time frame: 10 weeks and 6 months

    Scores on the Understanding COPD self-management questionnaire

Sponsors and collaborators

Lead sponsor

Aberystwyth University

Other

Collaborators

  • Hywel Dda Health Board

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 28, 2017
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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