COPD Pal Phase 2: A self-management app for Chronic Obstructive Pulmonary Disease. A pilot study

COPD Pal Phase 2: Assessing the uptake, engagement, and safety of a self-management app for Chronic Obstructive Pulmonary Disease. A pilot expediency study in a real-world setting

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14530045

Enrollment

Registered

2020-12-17

Start date

2020-01-20

Completion date

Unknown

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease Respiratory Chronic obstructive pulmonary disease

Interventions

Participants will be given a mobile smart phone with the COPD Pal app and instructed in its use. At baseline participants will be asked to complete the UCOPD questionnaire and data on COPD exacerbati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Willing and able to sign informed consent 2. Clinical diagnosis of COPD as defined by GOLD, 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 3. Life expectancy greater than 6 months

Exclusion criteria

Exclusion criteria: 1. Cognitive, visual, or motor impairment that would affect ability to see or use a smart phone 2. Current hospital inpatient or nursing home resident

Design outcomes

Primary

Measure	Time frame
1. Acceptable recruitment is defined as >50% of eligible people consenting to participate and follow-up data available for the self-management questionnaire (UCOPD) for >60% of enrolled participants at the end of the study period 2. Engagement will be measured in terms of active use of the App. Participant use will be automatically collected by COPD Pal and acceptable engagement defined as over 70% using app daily 3. Safety will be measured as the mean number of exacerbations or hospitalisations and deemed acceptable if not 20% more in the 3 months whilst using the app than the 3 months immediately pre-app. (GP contact and steroid/antibiotic use may increase as a result of better patient awareness of symptoms and as such will not be used as an indicator of safety)	—

Measure

Time frame

1. Acceptable recruitment is defined as >50% of eligible people consenting to participate and follow-up data available for the self-management questionnaire (UCOPD) for >60% of enrolled participants at the end of the study period 2. Engagement will be measured in terms of active use of the App. Participant use will be automatically collected by COPD Pal and acceptable engagement defined as over 70% using app daily 3. Safety will be measured as the mean number of exacerbations or hospitalisations and deemed acceptable if not 20% more in the 3 months whilst using the app than the 3 months immediately pre-app. (GP contact and steroid/antibiotic use may increase as a result of better patient awareness of symptoms and as such will not be used as an indicator of safety)

—

Secondary

Measure	Time frame
1. HRQoL measured using the COPD Assessment Test at baseline and weekly within the app for 6 weeks 2. Impact of the app on self-management confidence measured using the UCOPD questionnaire at baseline and 6 weeks	—

Countries

United Kingdom, Wales

Contacts

Public ContactSarah Rees

sarah.rees7@wales.nhs.uk+44 (0)1554 899108

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026