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

Not Applicable
Completed
Conditions
Chronic obstructive pulmonary disease
Respiratory
Registration Number
ISRCTN14530045
Lead Sponsor
Hywel Dda University Health Board
Brief Summary

2021 Results article in https://doi.org/10.1007/s12553-021-00534-w (added 11/11/2021)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
25
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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<br>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<br>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 Outcome Measures
NameTimeMethod
1. HRQoL measured using the COPD Assessment Test at baseline and weekly within the app for 6 weeks<br>2. Impact of the app on self-management confidence measured using the UCOPD questionnaire at baseline and 6 weeks
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