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

NCT04142957 | Completed

• 1 other identifier: 270736
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COPD

Keywords

COPD; Self-management; Qualitative; Empowerment; Telehealth

Outcome Measures

Primary Outcomes (1)

• Thematic Themes

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

  2 hours

Study Arms (1)

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.

Other: COPD Pal

Interventions

COPD Pal OTHER

'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.

Focus Groups

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

15 people meeting the criteria above

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hywel Dda Health Board: lead
• Welsh Government: collaborator
• Bond Digital Health Ltd.: collaborator
• Bevan Commission: collaborator

Study Sites (1)

Prince Philip Hospital

Llanelli, Carmarthenshire, SA148LQ, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Empowerment

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Study Officials

• Liam Knox

  Hywel Dda University Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: October 25, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

GB (1)