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COPDNCT04142957

COPD Pal Phase 1: A Self-management App in COPD

An observational study of COPD, run by Hywel Dda Health Board at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chronic Obstructive Pulmonary Disease (COPD) is a widespread condition which causes a poorer health status, reduced exercise, and lung function impairment. COPD exacerbations are a sustained worsening of symptoms beyond day-to-day variation and are responsible for one in eight hospital emergency admissions. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
COPD
What is being tested?
COPD Pal
How many people
12 participants
Where
1 siteUnited Kingdom
Study dates
25 Oct 2019to 31 Dec 2019
Phase
Observational
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 15 people meeting the criteria above

Who may be able to join

  • Willing and able to provide written informed consent.
  • Clinical diagnosis of COPD as defined by GOLD (Vogelmeier, et al., 2018; https://goldcopd.org/wp-content/uploads/2018/11/GOLD-2019-v1.7-FINAL-14Nov2018-WMS.pdf), i.e. greater than 40 years old, ≥ 10 pack years smoking history, post-bronchodilator FEV1/FVC ratio of 0.7, with FEV1 less than 80% predicted.
  • Owns, or has access to, a smart phone.

Who cannot join

  • Unwilling or unable to provide written informed consent.
  • Cognitive, visual, or hearing impairment which would affect communication in a group-setting or ability to see and use a smart phone.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Prince Philip Hospital

    Llanelli, Carmarthenshire, SA148LQ

Other trials in United Kingdom

About this study

Official title: COPD Pal Phase 1: Assessing the Usability and Acceptability of a Self-management App for Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) is a widespread condition which causes a poorer health status, reduced exercise, and lung function impairment. COPD exacerbations are a sustained worsening of symptoms beyond day-to-day variation and are responsible for one in eight hospital emergency admissions. Although extensive users of healthcare, people with COPD are primarily responsible for their condition 99% of the time and self-management has been highlighted as a crucial component for COPD care. To enable greater awareness of changing symptoms, a self-management app (COPD Pal) will be created by Bond Digital Health Ltd (BDH) to enable people with COPD to input information pertinent to their condition. The aim of COPD Pal, which is akin to a paper diary, is to empower patients to take more control of their disease and allow them to provide healthcare professionals with accurate, personalised data during clinic consultations.

This project aims to assess the usability and acceptability of COPD Pal using qualitative methodology (phase 1). It is proposed that 13-15 people with COPD will be invited to attend a focus group and be given COPD Pal (V1) with which to interact. Semi-structured questions will then be asked to facilitate conversation regarding their initial experiences of using COPD Pal. Focus groups will be audio-recorded, transcribed, and a Thematic Analysis conducted. Thematic themes will be provided to BDH, the creators of COPD Pal, with which to develop the app further (V2). Thematic themes will be provided to participants to confirm accuracy and ensure methodological rigour. A final report will be provided to both research participants and to BDH.

Findings from this research will inform the second phase feasibility study of V2 of COPD Pal.

Read the detailed description

Chronic Obstructive Pulmonary Disease (COPD) is a global problem, with 210 million sufferers and 3 million deaths annually. It is predicted to become the third most common cause of death worldwide by 2030. There are 1.2 million people with known COPD in the UK, but this is likely to be an underestimate. People with COPD have daily symptoms, a poorer health status, reduced exercise capacity, and impairment in lung function. A sustained worsening of symptoms above day-to-day variation, in response to infection or pollution, is termed an acute exacerbation. Exacerbations of COPD are the second most common cause of emergency admission to hospital in the UK, being responsible for one in eight (130,000) of the total, as well as 1 million bed days and an annual National Health Service (NHS) expenditure of over £500M in 2015.

Despite people with the condition being extensive users of the NHS, approximately only 1% of their time is spent with healthcare professionals. The rest of the time, people with COPD are encouraged to self-manage their condition; where, such behaviours include regular exercise, taking prescribed medication, being aware of symptoms, and attending healthcare appointments. Supporting self-management behaviours has been highlighted as crucial for the care of people with COPD. Despite the positive relationship between self-management and health outcomes, these behaviours are seldom conducted and adherence to medication is historically low.

To enable greater awareness of the change of his symptoms (i.e. better self-management), Ian Bond - who lives with COPD - created a simple diary which allowed him to identify when he was likely to have an exacerbation and thus take preventative action. Creating Bond Digital Health Ltd. (BDH; Cardiff, UK; https://bondhealth.co.uk/) he transformed this paper tool into a basic electronic diary. This quickly evolved into the development of an easy-to-use smart phone app. 'COPD Pal' aims to allow people with COPD to track and manage their condition. It enables patients to log symptoms (e.g. COPD assessment Test), wellness (e.g. quality of life such as EQ-5D), and medications, to help them become more engaged in their own care.

Showing their digital health data to a healthcare professional, during the consultation (by the patient), can guide communication, and empower the patient to lead their clinic appointment, and to become more positively involved in their own care. It should also help any healthcare professional in looking at trends and changes (or consistencies) from baseline health status which are unique for that patient. It is akin to a patient bringing a paper diary to show their healthcare professional the day-to-day variation in their chronic disease.

By improving self-management, illness understanding, and confidence in people with COPD, the app allows greater locus of control and hopefully will lead to reduced GP contacts, number and length of hospitalisations, and present real and immediate cost-savings to the NHS.

Welsh Government have funded (Efficiency through Technology Programme (ETTP), Social Research Number: 51/2017) a collaborative project between BDH and Hywel Dda University Health Board (HDUHB). BDH and their specialist software engineers are developing the prototype, working app. HDUHB have been funded (£16,000) to conduct a quantitative clinical trial and patient focus groups in the later design phases of the app to investigate suitability and usability, and test early feasibility in a real-world setting. It is hoped that such a study could also help improve these aspects for future versions of COPD Pal.

This project describes the Clinical Phase 1, focus groups and aims to answer the research question: 'how do people with COPD experience the usability and acceptability of the COPD Pal app?'

Conditions
COPD
Being tested
COPD Pal
Keywords
COPD, Self-management, Qualitative, Empowerment, Telehealth
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Empowerment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COPD PalOther

    'COPD Pal' aims to allow people with COPD to track and manage their condition. It enables patients to log symptoms (e.g. COPD assessment Test), wellness (e.g. quality of life such as EQ-5D), and medications, to help them become more engaged in their own care.

Study groups in NCT04142957
Study groupRoleWhat they receive
Focus GroupsThe investigators will invite 13-15 participants to attend the focus groups, of which it is expected that 10-12 to attend. Participants will be asked to bring a smart phone. An Informed Consent Form will be signed by the participant and a delegated researcher before the focus groups begin. The current generation of COPD Pal will be downloaded onto the participants' own smart phones (see Appendix 1 for current screenshots of app), participants will then be explained the purpose of the app, and asked to interact with it for 15-60 minutes, as required. A semi-structured focus group will then be conducted with the participants to facilitate conversation and discussion regarding COPD Pal. Once introductions have been completed, questions will be asked relating to the usability and acceptability of COPD Pal (see the Interview Schedule, Appendix 2). The focus group will last 30-60 minutes, as required.
Receives: Other: COPD Pal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Thematic Themes

    The Investigators will conduct focus groups to obtain qualitative data (i.e. no scale will be used)

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study start25 Oct 2019
  3. Primary completion30 Nov 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04142957
Sponsor's protocol ID
270736
Status last verified
Oct 2023
First submitted
25 Oct 2019
Last updated
25 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of COPD, run by Hywel Dda Health Board at 1 site 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 3 inclusion and 2 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 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Thematic Themes (time frame: 2 hours). 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 25 Oct 2023.

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