Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001076167
Ethics application status
Approved
Date submitted
23/07/2019
Date registered
5/08/2019
Date last updated
11/02/2021
Date data sharing statement initially provided
5/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Reboot online – does telephone support improve outcomes?
Scientific title
Evaluating the translation of an online chronic pain treatment program into clinical practice – can the addition of telephone support improve adherence and outcomes?
Secondary ID [1] 298814 0
Nil known
Universal Trial Number (UTN)
U1111-1237-4046
Trial acronym
Nil
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 313763 0
Condition category
Condition code
Musculoskeletal 312171 312171 0 0
Other muscular and skeletal disorders
Neurological 312242 312242 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Reboot Online program with telephone support (Intervention): Participants will receive the standardised Reboot Online program in conjunction with telephone support. The Reboot Online program consists of 8-lessons delivered over 16 weeks, with a new lesson released fortnightly. This program is based on the existing multidisciplinary pain management program run at St Vincent's hospital, Sydney. It incorporates material on education and skills training in areas such as thought challenging, goal setting, pacing, communication skills, stress management, movement and reactivation. Each lesson takes approximately 1 hour to complete. With each lesson there are additional homework tasks related to the information presented in the lesson eg thought diary, sleep diary, thought challenging exercise. In addition, in contrast to existing online pain programs, the Reboot online program incorporates a suite of graded physical exercises, including stretching and strengthening exercises. The program encourages patients to choose exercises and/or some form of movement to perform regularly that is tailored to the individual interests of the patient. The is no formal individualised exercise prescription rather the patient is encouraged to incorporate movement into their daily life. The program will be delivered via the website www.thiswayup.org.au, and all participants will be encouraged via the online program to carry out homework activities and the graded exercise program between lessons. Participants will receive one phone call every fortnight for the duration of the program (8 in total). The phone call will be conducted by a clinician experienced in the management of chronic pain. During the call, participants will be asked to report on their progress, and will be encouraged to continue engaging with the program. They will have the opportunity to discuss any challenges or hurdles they are experiencing, and possible strategies to overcome these, as well as receive feedback on their progress. The phone call will be up to 15 minutes in duration.

Intervention code [1] 315079 0
Treatment: Other
Comparator / control treatment
Reboot Online program – usual care (Control): Participants will receive the standardised Reboot Online program. This consists of 8-lessons delivered over 16 weeks, with a new lesson released fortnightly. The program will be delivered via the website www.thiswayup.org.au, and all participants will be encouraged via the online program to carry out homework activities and the graded exercise program between lessons
Control group
Active

Outcomes
Primary outcome [1] 320807 0
Primary outcome: Adherence to the program will be collected using software existing in the Reboot Online program. It will be assessed as the percentage of people who complete all 8 lessons of the program.
Timepoint [1] 320807 0
Primary outcome of adherence will be collected at post treatment
Secondary outcome [1] 372912 0
Tampa Scale of Kinesiophobia (TSK ) – a validated self-report measure of fear and avoidance of movement,
Timepoint [1] 372912 0
Pre - immediately pre-program
post- within 1 week of completing program
3 month follow up- 3 months from completing program
Secondary outcome [2] 372913 0
Brief Pain Inventory (BPI) – a validated self-report measure to assess the severity of pain and the impact of pain on daily functions,
Timepoint [2] 372913 0
Pre - immediately pre-program
post- within 1 week of completing program
3 month follow up- 3 months from completing program
Secondary outcome [3] 372914 0
Pain Disability Index (PDI)– a validated self-report index of pain related disability
Timepoint [3] 372914 0
Pre - immediately pre-program
post- within 1 week of completing program
3 month follow up- 3 months from completing program
Secondary outcome [4] 372915 0
Pain Self-efficacy Questionnaire (PSEQ ) – a validated self-report measure of a participant’s perceived ability to manage their pain.
Timepoint [4] 372915 0
Pre - immediately pre-program
post- within 1 week of completing program
3 month follow up- 3 months from completing program
Secondary outcome [5] 372916 0
Kessler-10 (K10)–a validated measure of general psychological distress
Timepoint [5] 372916 0
Pre - immediately pre-program
post- within 1 week of completing program
3 month follow up- 3 months from completing program
as well as before each lesson
Secondary outcome [6] 372917 0
International Physical Activity Questionnaire (IPAQ)- a validated self reported measure of physical activity
Timepoint [6] 372917 0
Pre - immediately pre-program
post- within 1 week of completing program
3 month follow up- 3 months from completing program

Eligibility
Key inclusion criteria
Participants will include those who meet the following eligibility criteria:
• Experiencing persistent pain, for > three months
• Aged 18 years or over
• Have access to the internet, and a computer/smartphone/tablet
• Stable medication usage over the past 3 months
• Willing to provide the name and address of their general practitioner
• Willingness to give informed consent and willingness to participate to and comply with the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychosis, bipolar disorder, substance abuse or dependence, and or extremely severe depression Participants who are scheduled to have a surgical intervention/treatment for chronic pain conducted during the course of the program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment allocation will be blinded until an offer of treatment is made. Initial diagnostic interviews will be conducted blind to treatment allocation. In addition, the primary outcome data is based on self-report assessment which protects from experimenter bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once enrolled, participants will be randomly assigned to either the Reboot online – telephone support group (n=40) or Control group (n=40) for the RCT using the www.random.org. Random allocation numbers will be determined by an RA who is independent from the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
na
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using SPSS software (IBM), using an intent-to-treat approach. Between-group differences in the primary outcome measure (adherence), will be examined via chi-squared analyses, with binary factors of group and adherence status (complete, incomplete). Multilevel linear mixed models will be conducted separately for each quantitative outcome measure, with fixed factors of treatment group, time, and the treatment group by time. A random effect of participant will be included in the model to allow different trajectories within each participant. Effects will be modelled using the restricted maximum likelihood (REML) model estimation method with the appropriate covariance structure specified to account for the correlation between the time-points. Effect sizes and corresponding 95% confidence intervals at each time point (post, 3-months follow-up) will be estimated from these models. Characteristics of completers and dropouts will be examined to determine any variables associated with attrition.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/08/2019
Actual
5/09/2019
Date of last participant enrolment
Anticipated
19/12/2019
Actual
28/04/2020
Date of last data collection
Anticipated
3/07/2020
Actual
1/12/2020
Sample size
Target
80
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14297 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 27294 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 303367 0
Charities/Societies/Foundations
Name [1] 303367 0
SVHA Inclusive Health Innovation Fund – Research Grants
Country [1] 303367 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Hospital, Darlinghurst
Address
St Vincent's Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 303399 0
None
Name [1] 303399 0
na
Address [1] 303399 0
na
Country [1] 303399 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303897 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 303897 0
Ethics committee country [1] 303897 0
Australia
Date submitted for ethics approval [1] 303897 0
29/03/2019
Approval date [1] 303897 0
24/05/2019
Ethics approval number [1] 303897 0
2019/ETH08682

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

Contacts
Principal investigator
Name 95170 0
Dr Tania Gardner
Address 95170 0
St Vincent's Hospital
Department of Pain Medicine
390 Victoria St
Darlinghurst
NSW 2010
Country 95170 0
Australia
Phone 95170 0
+61 2 83823897
Fax 95170 0
Email 95170 0
[email protected]
Contact person for public queries
Name 95171 0
Tania Gardner
Address 95171 0
St Vincent's Hospital
Department of Pain Medicine
390 Victoria St
Darlinghurst
NSW 2010
Country 95171 0
Australia
Phone 95171 0
+61 2 83823897
Fax 95171 0
Email 95171 0
[email protected]
Contact person for scientific queries
Name 95172 0
Tania Gardner
Address 95172 0
St Vincent's Hospital
Department of Pain Medicine
390 Victoria St
Darlinghurst
NSW 2010
Country 95172 0
Australia
Phone 95172 0
+61 2 83823897
Fax 95172 0
Email 95172 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data of primary and secondary outcomes collected during the trial, after de-identification
When will data be available (start and end dates)?
beginning 3 months and ending 5 years after main results publication
Available to whom?
case by case basis at the discretion of the principal investigator
Available for what types of analyses?
for the analysis of approved proposals
How or where can data be obtained?
access subject to approval by principal investigator ([email protected])


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
SourceTitleYear of PublicationDOI
EmbaseThe Effect of Adjunct Telephone Support on Adherence and Outcomes of the Reboot Online Pain Management Program: Randomized Controlled Trial.2022https://dx.doi.org/10.2196/30880
N.B. These documents automatically identified may not have been verified by the study sponsor.