Use of the SMART COPD Physical Activity App in Pulmonary Rehabilitation

NCT02691104 | Completed

• 1 other identifier: STH19149
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (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

  Two years

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

OTHER

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

Interventions

SMART COPD app to promote physical activity in COPD. Used in conjunction with a Fitbit Charge DEVICE

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

Also known as: The app has been developed by the research team and is not commercially available. A Fitbit® Charge pedometer will be used

Intervention

Control DEVICE

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

Also known as: A Fitbit® Charge pedometer will be used

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator
• National Institute for Health Research: CLAHRC YH: collaborator
• The Rotherham NHS Foundation Trust: collaborator
• Doncaster And Bassetlaw Hospitals NHS Foundation Trust: collaborator

Study Sites (3)

Doncaster and Bassetlaw Hospitals NHS Foundation Trust

Doncaster, United Kingdom

Location

The Rotherham NHS Foundation Trust

Rotherham, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Hawley

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 25, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 27, 2018

Record last verified: 2018-09

Locations

GB (3)