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Trial registered on ANZCTR


Registration number
ACTRN12619000856112
Ethics application status
Approved
Date submitted
29/05/2019
Date registered
17/06/2019
Date last updated
5/06/2023
Date data sharing statement initially provided
17/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Using behaviour change interventions to reduce sedentary time in people with chronic obstructive pulmonary disease
Scientific title
In adults with chronic obstructive pulmonary disease do behaviour change techniques reduce sedentary time?
Secondary ID [1] 297639 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 311909 0
Condition category
Condition code
Respiratory 310491 310491 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Behaviour change techniques will be delivered by the PhD student who is the co-ordinating principal investigator who is a physiotherapist who has attended a HealthChange Methodology training module. The location where the intervention will be delivered will be in Physiotherapy departments (Joondalup Health Campus, Bentley Health Service and Rockingham General Hospital and an addition of Royal Perth Hospital site) for initial baseline measures and consent from participant twice (Phase 0) and once a week for eight weeks (Phase 1) and at participants' homes once a week for five weeks and then once a month for 5 months (Phase 2 and 3). The sessions will be for approximately 40 minutes.
The content of the health education this will be conducted in all settings i.e. hospital and the participant's home, and will contain will be multi component with the aim of reducing sedentary time that has accumulated in prolonged unbroken bouts. Health education will contain simple content information about the general disease process of COPD and the impact of sedentary behaviour has on their cardio metabolic system and how these known risk factors can be reduced. The health education is delivered to the participant via personalised: face-to-face, one-on-one delivery mode, based on Theoretical Domain Framework and Michie's Taxonomies. The participant engages with behaviour change techniques by writing in a work book diary where the PhD student and participant will review action coping planning. Goals for reducing sedentary time and replacing it with light intensity physical activity, for the next or month depending on Phase are established during these sessions. The information is also conveyed by support of a loved-one who is invited to attend all sessions. There is also short " vignettes" short film of previous pilot study participant's lived experience of behaviour change.
Other interactive modes of delivering behaviour change techniques will be also done with a support group format with other participants and their loved-one ( this will be done between Phase 1 and 2). The support group will be a one-off session which will be facilitated by the PhD candidate where participants and their loved one are invited. These sessions will be held at the local hospital where the participants did their pulmonary rehabilitation classes and it will run for about an hour. The content of this session will focus on the participant's experience of the study and the behaviour change intervention. The loved-one will also be able to contribute to the discussion of these experiences from their perspective. The session is designed to be supportive where information is shared and may help other participants. The session will be recorded.
Additional strategies that may be used are prompting such as personalised phone or text messages depending on the participant's preference, which is provided to all participants once a week to encourage adherence to specific behaviour change goals for each participant. These messages are designed to reflect the participant's own requirement's with the behaviour change intervention, e.g. 'Betty, if you have been sitting continuously for 30 minutes, try and stand up and move for at least three minutes'.
The Fitbit wearable device will be used as an intervention where the participant will wear the device on their non dominant wrist. The participant will wear this for 24 hours a day through out the study for nine months. The device will be able to give the participant instant self monitoring via a smart phone to give them feedback to their sedentary time and physical activity.
Adherence with Fitbit use will be monitored remotely via Fitbit emails to the PhD student and reviewed once there is a scheduled visit throughout the Phases.
At this stage the three recruitment sites are not offering Pulmonary Rehabilitation classes (PR) or assessments, as the hospital referrals of patients to the Pulmonary Rehabilitation class was the only source of recruitment for this study. The current patients in Phase 2 (PR) are being reviewed once a week by the treating physiotherapist via tele-health from the hospital to the patient's homes.
The above intervention stays the same only the location and the delivery method may change while participants are in self-isolation.
For Phase 1-3 the participants in the study are now being reviewed either via social distancing in an open air capacity e.g. nearby park or via visual audio technology e.g. face-time. Prior to seeing the participant checklist is done over the phone the day before the participant is reviewed to ensure safety for participant and PhD student. In regards to the semi-structured interview, focus group and exit interview this will be conducted using either audio recording with social distancing or via remote audio/ visual technology what ever is feasible for the participant and PhD student. The focus group will be was delayed to Phase 3 via audio/ visual technology due to not being able to safely conduct a face-to-face support group environment with participants.
Intervention code [1] 313871 0
Behaviour
Intervention code [2] 313874 0
Lifestyle
Intervention code [3] 314664 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319356 0
Sedentary time. This will be measured by diaries (self reporting) and the activPAL (motion sensor)
Timepoint [1] 319356 0
Multiple time points for sedentary time the primary outcome and this is a feature of the study design chosen for this study of Single Case Experimental Design.
Visual analysis is a concept used where the data is plotted against time, to explore patterns of response ( e.g. the stability of the data within Phase 0 and the immediacy of the response by comparing data collected at the end of a Phase with that collected at the beginning of the nest Phase).
Phase 0: baseline measures before intervention ( 10 time points)
Phase 1: once a week for eight weeks ( eight time points)
Phase 2: once a week for five weeks (five time points)
Phase 3: once a month for five months ( five time points)
Primary outcome [2] 320354 0
Time spent in light intensity physical activity (LIPA) this will be measured by diaries ( self-reporting ) and the activPAL.
Timepoint [2] 320354 0
Multiple time points for LIPA the primary outcome (2) and this is a feature of the study design chosen for this study of Single Case Experimental Design.
Visual analysis is a concept used where the data is plotted against time, to explore patterns of response ( e.g. the stability of the data within Phase 0 and the immediacy of the response by comparing data collected at the end of a Phase with that collected at the beginning of the nest Phase).
Phase 0: baseline measures before intervention ( 10 time points)
Phase 1: once a week for eight weeks ( eight time points)
Phase 2: once a week for five weeks (five time points)
Phase 3: once a month for five months ( five time points)
Secondary outcome [1] 367873 0
In regards to intervention fidelity, at the completion for each Phase, knowledge and acquisition by the participant will be assessed using study specific questionnaire at the end of each Phase (0-3) and evaluation of their competence with pre-specified tasks (e.g. interpretation of data collected using wearable technology), Consistency in the intervention design will be achieved by ensuring that there is a written study protocol which specifies the minimum and maximum number and duration of each contact with the participants.
The PhD student will have a checklist that will summarise all the behaviour change techniques that were used. Exit interview with participant and their loved-one to find out what techniques were useful and those techniques that were unhelpful
Timepoint [1] 367873 0
End of Phase 0 ( 3 week mark), end of Phase 1 ( 11 week mark), end of Phase 2 ( 16 week mark), end of Phase 3 (39 weeks),

Eligibility
Key inclusion criteria
greater than or equal to 40 years, primary diagnosis of chronic obstructive pulmonary disease, referred to participate in a hospital-based Pulmonary Rehabilitation Program, access to a Smart phone
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
self reported musculoskeletal or cardiac condition that will impact on their ability to engage in light intensity physical activity, prescribed supplemental oxygen or a rollator, and limited understanding of the English language.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Single Case Experimental Design (SCED)
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Qualitative, quantitative and SCED specific data analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2019
Actual
5/09/2019
Date of last participant enrolment
Anticipated
1/06/2021
Actual
18/03/2021
Date of last data collection
Anticipated
1/04/2022
Actual
13/03/2022
Sample size
Target
20
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 13316 0
Joondalup Health Campus - Joondalup
Recruitment hospital [2] 13317 0
Bentley Health Service - Bentley
Recruitment hospital [3] 13318 0
Rockingham General Hospital - Cooloongup
Recruitment hospital [4] 24873 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 25916 0
6027 - Joondalup
Recruitment postcode(s) [2] 25917 0
6102 - Bentley
Recruitment postcode(s) [3] 25918 0
6168 - Cooloongup
Recruitment postcode(s) [4] 40521 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 302962 0
University
Name [1] 302962 0
Curtin University
Country [1] 302962 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University
Kent Street
Bentley, Perth WA 6845
Country
Australia
Secondary sponsor category [1] 302011 0
None
Name [1] 302011 0
Address [1] 302011 0
Country [1] 302011 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302850 0
Joondalup Health Service Human Ethics Research Committee
Ethics committee address [1] 302850 0
Ethics committee country [1] 302850 0
Australia
Date submitted for ethics approval [1] 302850 0
24/04/2019
Approval date [1] 302850 0
20/06/2019
Ethics approval number [1] 302850 0
Ethics committee name [2] 307902 0
South Metropolitan Health Service
Ethics committee address [2] 307902 0
Ethics committee country [2] 307902 0
Australia
Date submitted for ethics approval [2] 307902 0
01/08/2019
Approval date [2] 307902 0
30/08/2019
Ethics approval number [2] 307902 0
RGS: 0000003353
Ethics committee name [3] 307903 0
East Metropolitan Health Service
Ethics committee address [3] 307903 0
Ethics committee country [3] 307903 0
Australia
Date submitted for ethics approval [3] 307903 0
31/10/2019
Approval date [3] 307903 0
02/12/2019
Ethics approval number [3] 307903 0
RGS: 0000003353
Ethics committee name [4] 307904 0
Curtin University of Technology
Ethics committee address [4] 307904 0
Ethics committee country [4] 307904 0
Australia
Date submitted for ethics approval [4] 307904 0
18/09/2019
Approval date [4] 307904 0
07/10/2019
Ethics approval number [4] 307904 0
HRE2019-0429

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91606 0
Ms Fiona Coll
Address 91606 0
Physiotherapy
Level 3, B Block
Royal Perth Bentley Group
Wellington Street Perth 6000 WA
Country 91606 0
Australia
Phone 91606 0
+61 8 92242076
Fax 91606 0
Email 91606 0
fionalc6@bigpond.com
Contact person for public queries
Name 91607 0
Fiona Coll
Address 91607 0
Physiotherapy
Level 3, B Block
Royal Perth Bentley Group
Wellington Street Perth 6000 WA
Country 91607 0
Australia
Phone 91607 0
+61 892242076
Fax 91607 0
Email 91607 0
fionalc6@bigpond.com
Contact person for scientific queries
Name 91608 0
Fiona Coll
Address 91608 0
Physiotherapy
Level 3, B Block
Royal Perth Bentley Group
Wellington Street Perth 6000 WA
Country 91608 0
Australia
Phone 91608 0
+61 892242076
Fax 91608 0
Email 91608 0
fionalc6@bigpond.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.