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Trial registered on ANZCTR


Registration number
ACTRN12621001178831
Ethics application status
Approved
Date submitted
27/07/2021
Date registered
2/09/2021
Date last updated
16/08/2022
Date data sharing statement initially provided
2/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Telerehab activity intervention for people with Guillain Barre Syndrome
Scientific title
Impact of a telerehabilitation physical activity intervention on fatigue levels for people with Guillain Barre Syndrome
Secondary ID [1] 303851 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Guillain Barre Syndrome 321416 0
Condition category
Condition code
Neurological 319176 319176 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 320783 320783 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We have developed a limited contact telerehabilitation intervention based on behavioural change principles. A physiotherapist will customise the intervention for each participant with consultation and based on the goal elicited and the participant’s contextual factors. The intervention comprises the coaching style used by the physiotherapist, supplemented with use of a wrist worn activity tracker by each participant. These two components of the intervention encompass a number of known behaviour change techniques from a well-established taxonomy. All contact will be made by phone and/or videoconferencing and limited to a maximum of six hours in total over a 12-week period.
The physiotherapist will follow a similar intervention outline for each participant with the ability to tailor the content of the session to each participant’s goals, concerns, problems and ability by selecting from a menu of options based on the behavioural change taxonomy. It is anticipated that the behavioural change techniques used for each participant will encompass goal setting, provision of feedback, problem solving, action planning and instruction but that the specific techniques selected will differ because they will be customised for each participant. The physiotherapist will meet remotely with each participant on a weekly basis via teleconferencing or phone, as best suits the participant. It is anticipated that the first session will take 30-60 minutes and the aim of the first session will be for the physiotherapist and participant to identify an activity the participant is most likely to engage in (acceptable, pleasant and practical), negotiate and agree a weekly goal and action plan and for the physiotherapist to provide support and encouragement. The physiotherapist will also specifically provide information and instruction on the promotion of activity based on current guidelines (1) relative to each participant’s current level of activity whilst also accounting for their level of fatigue, which is of particular concern for individuals with persistent fatigue. At the first session, the physiotherapist will review the main behaviour change features (goal setting, self monitoring, provision of feedback, prompting through environmental cues) of the activity tracker (sent to each participant prior to their first session). The physiotherapist and participant will collaboratively decide how best to integrate the use of the activity tracker into the participant’s action plan.
The duration of subsequent sessions will be 15-30 minutes each. In these weekly sessions, the physiotherapist and participant will review the week’s progress, identify barriers that the participant has encountered and discuss possible solutions, resulting in an agreed goal and action plan for the subsequent week. The physiotherapist will supplement the weekly sessions with one text message (or email) per week to encourage progress towards the agreed goal.
Monitoring fidelity /'adherence' - Outcomes assessment includes collection of steps and sedentary time from fitbits, and activity engagement will be captured as part of the intervention itself.

1 US Department of Health and Human Services. Physical Activity Guidelines for Americans [Internet]. 2nd ed. Washington, DC, 2018; and Walk. Run. Dance. Play. What’s your move? - Move Your Way | health.gov [Internet]. [cited 2021 Jul 6].
Intervention code [1] 320155 0
Rehabilitation
Comparator / control treatment
Participants in this study act as their own controls, baseline being establised in the initial phase of the Single System Design by collecting all outcome questionnaire based measures and fitbit data at week 0,2 and 4.
Control group
Active

Outcomes
Primary outcome [1] 327048 0
Fatigue severity - assessed by Fatigue Severity Scale
Timepoint [1] 327048 0
baseline (at week 0, 2 and 4), during the intervention period (at weeks 8, 12 and 16) and during followup phase (at weeks 18, 20, 22 and 40)
Primary outcome [2] 327049 0
Daily steps as recorded by wrist worn fitbit
Timepoint [2] 327049 0
baseline (at week 0, 2 and 4), during the intervention period (at weeks 8, 12 and 16) and during followup phase (at weeks 18, 20, 22 and 40)
Primary outcome [3] 327050 0
Personal wellbeing index as indicated by online questionnaire - Personal wellbeing index
Timepoint [3] 327050 0
baseline (at week 0, 2 and 4), during the intervention period (at weeks 8, 12 and 16) and during followup phase (at weeks 18, 20, 22 and 40)
Secondary outcome [1] 393593 0
Exercise self efficacy (additional primary outcome) - assessed via online questionnaire "Exercise self-efficacy scale"
Timepoint [1] 393593 0
baseline (at week 0, 2 and 4), during the intervention period (at weeks 8, 12 and 16) and during followup phase (at weeks 18, 20, 22 and 40)
Secondary outcome [2] 393594 0
sedentary time (additional primary outcome) as recorded by wrist worn fit bit
Timepoint [2] 393594 0
baseline (at week 0, 2 and 4), during the intervention period (at weeks 8, 12 and 16) and during followup phase (at weeks 18, 20, 22 and 40)
Secondary outcome [3] 400473 0
Acceptability - assessed via one on one semi-structured interviews with each participant
Timepoint [3] 400473 0
between 22 and 40 weeks
Secondary outcome [4] 400474 0
Feasibility - assessed via one on one semi-structured interviews with each participant
Timepoint [4] 400474 0
Between 22 and 40 weeks

Eligibility
Key inclusion criteria
Adults greater than or equal to 18 years
• GBS onset more than 2 years previously
• Community-dwelling
• Walks in the community (Rivermead Mobility Index of greater than 10)
• Experiences fatigue (Fatigue Severity Scale greater than or equal to 4)
• Resident in New Zealand
• Access to the internet
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Currently receiving rehabilitation
• Has another health condition that impacts physical activity
• Has a contraindication for physical activity (as indicated by the Physical Activity Readiness Questionnaire (PAR-Q)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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 system design and qualitative interviews
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The single system design will yield data for each of the outcome measures, which will be graphed against time for each participant. Visual inspection will be used initially to look for any changes in data patterns (e.g. trend, level or variability) across the phases. The two standard deviation band test will be used to test for change in the intervention phase. Two standard deviation bands are constructed above and below the mean of the baseline measures. If at least two consecutive data points in the intervention phase fall outside the two standard deviation band, changes from baseline to intervention are considered significant. If there is a trend in the baseline a split-middle method of trend estimation (celeration line) will be used to apply a best-fit trend line to the data points within a phase. The effect of the treatment will be assessed by comparing the proportion of data points above and below the line of the phases.
Conventional content analysis will be used to analyse interview data. Transcripts will be read and reread and preliminary coding will focus on manual coding of sentences or phrases after which all transcripts will be imported in to QSR NVivo (a qualitative data management software package) where preliminary codes will be examined and grouped into meaningful clusters. Constant comparative methods will inform analysis, with coded data checked within and between identified clusters and across participants against new data to test and refine themes.
We also plan to capture the actual time for intervention delivery and the materials used for the intervention as a guide for future resourcing costs.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2021
Actual
12/11/2021
Date of last participant enrolment
Anticipated
28/03/2022
Actual
24/03/2022
Date of last data collection
Anticipated
31/01/2023
Actual
Sample size
Target
10
Accrual to date
Final
8
Recruitment outside Australia
Country [1] 23576 0
New Zealand
State/province [1] 23576 0
Whole country

Funding & Sponsors
Funding source category [1] 308245 0
Charities/Societies/Foundations
Name [1] 308245 0
Neurological Research New Zealand
Country [1] 308245 0
New Zealand
Primary sponsor type
University
Name
AUT University
Address
AUT University | North Shore Campus, 90 Akoranga Drive, Northcote, 0627
Country
New Zealand
Secondary sponsor category [1] 309038 0
Charities/Societies/Foundations
Name [1] 309038 0
Guillain Barre Syndrome Support Group NZ Trust
Address [1] 309038 0
30 Higgs Road
Mapua 7005, Nelson
P.O. Box 21 Mapua 7048
Country [1] 309038 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308225 0
Health and Dissability Committee New Zealand
Ethics committee address [1] 308225 0
Ministry of Health Health and Disability Ethics Committees PO Box 5013. Wellington 6140
Ethics committee country [1] 308225 0
New Zealand
Date submitted for ethics approval [1] 308225 0
18/08/2021
Approval date [1] 308225 0
22/09/2021
Ethics approval number [1] 308225 0

Summary
Brief summary
As many as 60-80% of people with Guillain Barré Syndrome(GBS)report persistent fatigue which significantly limits everyday functioning even when they have made a good motor recovery. In other neurological conditions, there is evidence that regular physical activity can reduce fatigue, however the application of this research to GBS is less clear.Previous studies have utilised supervised exercise sessions in tertiary care centres, which is often both impracticable for people with GBS and does not address the sustainability of behaviour change needed to form lifelong physical activity habits. We have designed a limited contact telerehabilitation (all contact made by phone and/or videoconferencing) intervention based on behavioural change principles. A physiotherapist will customise the intervention which will be augmented by provision of a Fitbit to each participant to wear for the duration of the 12 week intervention.

We will use a single system design to investigate the effectiveness of the intervention to reduce fatigue in 10 people who have had GBS more than two years previously. We will explore participants' perspectives of acceptability and feasibility of the intervention through qualitative interviews. If this intervention is found to be acceptable, feasible and effective, it is extremely likely to be relevant to other neurological conditions where fatigue is a significant and persistent factor.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109990 0
Dr Suzie Mudge
Address 109990 0
Centre for Person Centred Research, AUT University, 90 Akoranga Drive, Northcote, Auckland, 0627, New Zealand
Country 109990 0
New Zealand
Phone 109990 0
+64 9 921 7096
Fax 109990 0
Email 109990 0
[email protected]
Contact person for public queries
Name 109991 0
Suzie Mudge
Address 109991 0
Centre for Person Centred Research, AUT University, 90 Akoranga Drive, Northcote, Auckland,0627, New Zealand
Country 109991 0
New Zealand
Phone 109991 0
+64 9 9219999
Fax 109991 0
Email 109991 0
[email protected]
Contact person for scientific queries
Name 109992 0
Suzie Mudge
Address 109992 0
Centre for Person Centred Research, AUT University, 90 Akoranga Drive, Northcote, Auckland, 0627 New Zealand
Country 109992 0
New Zealand
Phone 109992 0
+64 9 9219999
Fax 109992 0
Email 109992 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The number of participants is very small (n=10) and the rarity of the condition such that the likely hood of confidentiality breach by providing individual data is considered high.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12693Study protocol  [email protected]
12694Clinical study report  [email protected]
12695Ethical approval  [email protected]
12696Informed consent form  [email protected]



Results publications and other study-related documents

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