Clinical trial NCT02691104: Use of the SMART COPD Physical Activity App in Pulmonary Rehabilitation
Official title: Use of the SMART COPD Physical Activity App in Pulmonary Rehabilitation: a Randomised Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
name: National Institute for Health Research: CLAHRC YH
name: The Rotherham NHS Foundation Trust
name: Doncaster And Bassetlaw Hospitals NHS Foundation Trust
First posted: 2016-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators are carrying out a feasibility study to explore whether an app for physical activity in Chronic Obstructive Pulmonary Disease (COPD) is acceptable to people with the condition and to healthcare professionals who help patients manage the condition.

Detailed description: Chronic Obstructive Pulmonary Disease (COPD) is a long term lung condition which causes breathlessness, tiredness, coughing and chest infections. People with the condition often find it difficult to carry out day to day activities and to live a normal life. In recent years people with COPD have been encouraged to self-manage their condition, for example by increasing their physical activity, which could help them to live their life to the full. Recent advances in technology have the potential to help people do this. The SMART COPD 'app' which is being used in this study has been developed, based on previous research and the views of people living with the condition, to help people with COPD increase their physical activity. Physical activity is known to be important in helping people with COPD to enjoy better health and to carry out activities. The current study will investigate whether or not the app could be used alongside existing health services, and whether or not people with COPD, as well as healthcare professionals, find the 'app' acceptable and easy to use.

The investigators are working with three Pulmonary Rehabilitation (PR) teams in South Yorkshire (from Sheffield, Rotherham and Doncaster). PR is an education and exercise programme for people with lung conditions, which aims to teach people the skills to help them self-manage their condition. The first part of this feasibility study will investigate how PR is currently being delivered, and whether there would be any scope to include the app during and after PR to help people increase (or at least maintain) their physical activity levels longer term. This will be done by observing PR sessions, looking at how PR is delivered and referrals to the service, and through interactive workshops with healthcare professionals who deliver PR. The second part of the project will involve 'trying out' the app with a small group of people with COPD who are attending PR, to investigate whether the app is easy to use, whether any changes are needed, and the best way to use the app in the future. In order to determine whether the app successfully helps people with COPD to increase their physical activity levels, the investigators will need to carry out a much larger study in the future which compares use of the app with not having the app. The current feasibility project will help with planning this much larger study.

Eligibility criteria: Inclusion Criteria:

* A formal diagnosis of COPD;
* Attending a Pulmonary Rehabilitation (PR) course in Sheffield, Rotherham or Doncaster;
* Reasonable understanding of written and verbal English.

Exclusion Criteria:

* Not formally diagnosed with COPD;
* Deemed unable to attend standard PR;
* A cognitive impairment which prevents an individual giving informed consent;
* Does not understand written and verbal English.

Primary outcomes:
measure: Usability and Acceptability of the intervention, as measured using qualitative interviews with staff and patient participants
timeFrame: Two years
measure: Usability and Acceptability of the intervention, as measured using the System Usability Scale (SUS) (questionnaire with Likert-style questions)
timeFrame: Two years
measure: Usability and Acceptability of the intervention, as measured using data on patterns of use for the app and Fitbit which are automatically logged by these devices.
timeFrame: Two years
Secondary outcomes:
measure: Feasibility of conducting an RCT, including which outcome measures are of most relevance to people with COPD and healthcare professionals, whether those outcome measures would be feasible to use, and how feasible / acceptable randomisation would be
timeFrame: Two years
Other outcomes:
Locations:
city: Doncaster
country: United Kingdom
facility: Doncaster and Bassetlaw Hospitals NHS Foundation Trust
city: Rotherham
country: United Kingdom
facility: The Rotherham NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
Study officials:
affiliation: University of Sheffield
name: Mark Hawley
role: PRINCIPAL_INVESTIGATOR
References: