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.
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
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 group | Role | What they receive |
|---|---|---|
| Focus Groups | The 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.
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.
- First posted29 Oct 2019
- Study start25 Oct 2019
- Primary completion30 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hywel Dda Health Board
- Sponsor type
- University, hospital or other
- Collaborators
- Welsh Government, Bond Digital Health Ltd., Bevan Commission
- Responsible party
- Sponsor
- Investigators
- Liam Knox, Principal investigator, Hywel Dda University Health Board
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPD Pal Phase 1: Assessing the Usability and Acceptability of a Self-management App for Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04142957
- Acronym / sponsor ID
- 270736
- Conditions
- COPD
- Keywords
- COPD, Self-management, Qualitative, Empowerment, Telehealth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hywel Dda Health BoardUniversity, hospital or other
- Collaborators
- Welsh Government, Bond Digital Health Ltd., Bevan Commission
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 Oct 2019 (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.
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.
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?'
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focus Groups | – | Other: COPD PalThe 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 15 people meeting the criteria above
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| COPD Pal'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. | Other | Focus Groups |
Primary outcome
Thematic Themes
Time frame: 2 hours
The Investigators will conduct focus groups to obtain qualitative data (i.e. no scale will be used)
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 25 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for COPD
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
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
Hywel Dda University Health Board
1 site in 1 country: see every site and its status.
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.