Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Use of the SMART COPD Physical Activity App in Pulmonary Rehabilitation: a Randomised Feasibility Study
NCT number | NCT02691104 |
Other study ID # | STH19149 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | September 2018 |
Verified date | September 2018 |
Source | Sheffield Teaching Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Doncaster and Bassetlaw Hospitals NHS Foundation Trust | Doncaster | |
United Kingdom | The Rotherham NHS Foundation Trust | Rotherham | |
United Kingdom | Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield |
Lead Sponsor | Collaborator |
---|---|
Sheffield Teaching Hospitals NHS Foundation Trust | Doncaster And Bassetlaw Hospitals NHS Foundation Trust, National Institute for Health Research: CLAHRC YH, The Rotherham NHS Foundation Trust, University of Sheffield |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Usability and Acceptability of the intervention, as measured using qualitative interviews with staff and patient participants | Thematic analysis of interviews will be used to explore participants' views on the usability and acceptability of the intervention. | Two years | |
Primary | Usability and Acceptability of the intervention, as measured using the System Usability Scale (SUS) (questionnaire with Likert-style questions) | The SUS will provide an overall usability score for the intervention which will be comparable to other interventions which have used this scale. | Two years | |
Primary | 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. | Data on patterns of use of the devices will help us determine whether there are parts of the intervention which are not used, or how different parts of the system are used (e.g. goal-setting strategies). | Two years | |
Secondary | 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 | As part of the feasibility study we will investigate a number of outcome measure options for a future large scale RCT, including physical activity logged by the devices (e.g. number of steps, whether goals are reached etc). We will also investigate a number of scales / questionnaires which measure different concepts which are potentially of interest (e.g. St George's Respiratory Questionnaire for quality of life, Exercise Self-Regulatory Efficacy Scale, EuroQol 5 Dimensions questionnaire for cost effectiveness etc), and acceptability of different outcomes measures. Acceptability of randomisation will be assessed through thematic analysis qualitative interviews | Two years |
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