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Use of the SMART COPD Physical Activity App in Pulmonary Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02691104
Recruitment Status : Completed
First Posted : February 25, 2016
Last Update Posted : September 27, 2018
Sponsor:
Collaborators:
University of Sheffield
National Institute for Health Research: CLAHRC YH
The Rotherham NHS Foundation Trust
Doncaster And Bassetlaw Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Device: SMART COPD app to promote physical activity in COPD. Used in conjunction with a Fitbit Charge Device: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of the SMART COPD Physical Activity App in Pulmonary Rehabilitation: a Randomised Feasibility Study
Study Start Date : January 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention

Use of the app and Fitbit alongside 5-7 week pulmonary rehabilitation programme (plus goal-setting help from physiotherapist), and then app and Fitbit plus intermittent contact with physiotherapist for 8 weeks after pulmonary rehabilitation

NB Randomisation is being deployed to test the practicality / acceptability of randomising for a larger RCT. It is not being used to assess the efficacy of the intervention in the current study

Device: SMART COPD app to promote physical activity in COPD. Used in conjunction with a Fitbit Charge
An app which allows users to set physical activity goals, monitors progress towards those goals, and provides feedback to users. Several options for types of physical activity (daily walk, daily step count, and aerobic / strengthening exercises) which can be tailored to the individual user. Designed to be used in consultation with a physiotherapist initially, and then used independently by the individual with COPD. The app will first be used alongside pulmonary rehabilitation (PR), with physiotherapist advice on exercises and setting goals. After PR the individual with COPD will receive weekly contact from a physiotherapist for the first 4 weeks, and then no contact for the second 4 weeks
Other Name: The app has been developed by the research team and is not commercially available. A Fitbit® Charge pedometer will be used

Control

Attend 5-7 week pulmonary rehabilitation programme (usual care) and wear blinded Fitbit during pulmonary rehabilitation and for 8 weeks afterwards

NB Randomisation is being deployed to test the practicality / acceptability of randomising for a larger RCT. It is not being used to assess the efficacy of the intervention in the current study

Device: Control
Participants will follow the (usual care) PR programme. They will be asked to wear a blinided (cannot see step count) Fitbit Charge during the time they are on PR and then for 8 weeks afterwards
Other Name: A Fitbit® Charge pedometer will be used




Primary Outcome Measures :
  1. Usability and Acceptability of the intervention, as measured using qualitative interviews with staff and patient participants [ Time Frame: Two years ]
    Thematic analysis of interviews will be used to explore participants' views on the usability and acceptability of the intervention.

  2. Usability and Acceptability of the intervention, as measured using the System Usability Scale (SUS) (questionnaire with Likert-style questions) [ Time Frame: Two years ]
    The SUS will provide an overall usability score for the intervention which will be comparable to other interventions which have used this scale.

  3. 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. [ Time Frame: Two years ]
    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).


Secondary Outcome Measures :
  1. 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 [ Time Frame: Two years ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691104


Locations
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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, United Kingdom
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
National Institute for Health Research: CLAHRC YH
The Rotherham NHS Foundation Trust
Doncaster And Bassetlaw Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Mark Hawley University of Sheffield
Additional Information:
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02691104    
Other Study ID Numbers: STH19149
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases