Chronic Obstructive Pulmonary DiseaseNCT03263754
Do Educational Digital Films Enhance Patient COPD Outcomes?
A study testing Pocket Medic and Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Aberystwyth University at 2 sites in United Kingdom.
Trial summary
This study aims to assess the efficacy of Pocket Medic to promote self-management and pulmonary rehabilitation adherence in COPD patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pocket Medic and Pulmonary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Sep 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for pulmonary rehabilitation in Hywel Dda University Health Board.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Glangwilli Hospital
Carmarthen, Carmarthenshire, SA31 2AF
Prince Phillip Hospital
Llanelli, Carmarthenshire, SA14 8QF
About this study
Official title: 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.
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pocket Medic, Pulmonary Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pocket MedicBehavioural
10 short digital films utilising self-determination theory aiming to increase patient self-management
Pulmonary RehabilitationBehavioural
PR follows National Institute for Clinical Excellence guidelines delivering 14 sessions over 7 weeks utilising a multidisciplinary approach
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Pocket Medic; Behavioral: Pulmonary Rehabilitation |
| Control | Active comparator | Not described Receives: Behavioral: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient engagement
The level at which patients in the intervention arm watch the digital films
Measured: 10 weeks
Patient Adherence
The level at which patients attend pulmonary rehabilitation sessions
Measured: 10 weeks
Secondary outcomes (4)
Disease Knowledge
Scores on Bristol COPD Knowledge Questionnaire
Measured: 10 weeks and 6 months
Service Utilization
Number of General Practioner visits and hospitalizations
Measured: Baseline and 6 months
Psychological self-management
Patient scores on self-determination theory questionnaires modified to be relevant to COPD
Measured: 10 weeks and 6 months
Understanding COPD self-management
Scores on the Understanding COPD self-management questionnaire
Measured: 10 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start1 Sep 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aberystwyth University
- Sponsor type
- University, hospital or other
- Collaborators
- Hywel Dda Health Board
- Responsible party
- Sponsor
- Investigators
- Liam Knox, Principal investigator, Aberystwyth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263754
- Sponsor's protocol ID
- 10203918b3002e6f1be4a19987
- Status last verified
- Jan 2019
- First submitted
- 24 Aug 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Patients With Chronic Obstructive Pulmonary Disease Engaging With Educational Films in Addition to Pulmonary Rehabilitation Gain Health-related Improvements?
- ClinicalTrials.gov ID
- NCT03263754
- Acronym / sponsor ID
- 10203918b3002e6f1be4a19987
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Aberystwyth UniversityUniversity, hospital or other
- Collaborators
- Hywel Dda Health Board
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Pocket Medic, Behavioral: Pulmonary Rehabilitation |
| Control | Active comparator | Behavioral: Pulmonary Rehabilitation |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible for pulmonary rehabilitation in Hywel Dda University Health Board.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pocket Medic10 short digital films utilising self-determination theory aiming to increase patient self-management | Behavioural | Intervention |
| Pulmonary RehabilitationPR follows National Institute for Clinical Excellence guidelines delivering 14 sessions over 7 weeks utilising a multidisciplinary approach | Behavioural | Control, Intervention |
Primary outcome
Patient engagement
Time frame: 10 weeks
The level at which patients in the intervention arm watch the digital films
Patient Adherence
Time frame: 10 weeks
The level at which patients attend pulmonary rehabilitation sessions
4 secondary outcomes
Disease Knowledge
Time frame: 10 weeks and 6 months
Service Utilization
Time frame: Baseline and 6 months
Psychological self-management
Time frame: 10 weeks and 6 months
Understanding COPD self-management
Time frame: 10 weeks and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liam Knox principal investigator
Aberystwyth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pocket Medic and Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Aberystwyth University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient engagement (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.