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Trial registered on ANZCTR


Registration number
ACTRN12619000771156
Ethics application status
Approved
Date submitted
14/05/2019
Date registered
23/05/2019
Date last updated
23/05/2019
Date data sharing statement initially provided
23/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Co-creating and evaluating an online self-help treatment (iSelf-help) for people with persistent pain
Scientific title
Clinical and cost-effectiveness of an online delivered group-based pain management programme (iSelf-help) in improving pain-related disability for people with persistent pain - A non-inferiority randomised controlled trial
Secondary ID [1] 298169 0
None
Universal Trial Number (UTN)
U1111-1215-5284
Trial acronym
iSELFHELP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent non-cancer pain 312728 0
persistent primary pain 312729 0
persistent secondary pain 312730 0
Condition category
Condition code
Anaesthesiology 311230 311230 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 12-week group-based online-intervention (iSelf-help) will be delivered via an online smartphone application and a password-protected website.

iSelf-help: The iSelf-help has been co-designed with patients with persistent pain and Maori living with persistent pain and their whanau to ensure cultural appropriateness. The iSelf-help consists of 12 online modules similar to in-person pain management programme (PMP).

The 12 modules of iSelf-help are: 0) Welcome to Pain management programme, 1) Exercise, 2) Sensory nervous system, 3) Stress response, 4) Think, feel, do, 5) Memory of pain, 6) Taking charge, 7) Thinking and doing skills, 8) Medication, 9) Sleep, 10) Making plans with pain, 11) Sharing the journey, 12) Pulling it all together

Resources: Each module consists of a short introductory video (30s), educational video by a pain management clinician (5mins), videos of patient stories sharing their experiences of managing pain and associated symptoms relevant to the module, relaxation podcasts and additional resources such as animations, illustrated texts and links of additional resources.

Each module of iSelf-help will be made available to the participants at the beginning of each week. Participants are asked to use these resources at their own time.

In addition, the iSelf-help arm with 8 to 12 participants/group at baseline will receive two, 60-minute sessions weekly for 12 weeks.

One 60-minute session/week will be delivered via an online self-management platform by a dedicated pain management clinician (physiotherapist) of our research team. Each session comprises education (30mins), advice on guided exercises (15mins) and relaxation techniques (15mins). Education sessions are likely to focus on knowledge and Cognitive Behavioural Therapy-based self-management skills (e.g. pain education, activity pacing, relaxation, and distraction techniques) similar to in-person PMP. Participants are asked to attend the first session and any of the 5 sessions from the remaining 11 weeks.

Later in the same week, the second 60-minute session is likely to be an interactive online closed-group discussion moderated by a health coach (e.g. a trained volunteer from patient advisory group). The group discussion will focus on self-reflection, goal setting, and the sharing of experiences with peers about what went well, and what did not, over the week and developing peer support network. Participants are asked to attend these discussions at their own discretion.

Peer interaction: The community page of iSelf-help will provide opportunities for peer-interaction throughout the 12-week period. Acommunity manager (personnel with a health background) will monitor the page for safety of posts shared by participants.

Tracking: There will be opportunites for participants to track their exercise, mood level and thought diaries with reminders and nudges to encourage continued use of iSelf-help through the 12-week period.
Intervention code [1] 314473 0
Behaviour
Intervention code [2] 314534 0
Rehabilitation
Comparator / control treatment
The in-person PMP is the usual care arm. Eight to 12 patients/group at baseline will attend one 180-minute session/week over 12 weeks at either Wellington or Kenepuru Hospital, which is the current delivery model (Please see Supplementary material). Each session comprises weekly review (15mins), education (45mins), group exercise (45mins), relaxation (30mins) and a debrief (30mins). Weekly education modules focus on a range of self-management strategies (e.g. pain education, CBT, activity scheduling) delivered by pain management service clinicians including two physiotherapists, occupational therapist, psychologist, pain management nurse and a pain medicine specialist.
Control group
Active

Outcomes
Primary outcome [1] 320059 0
Pain related disability using modified Roland Morris Disability Questionnaire (RMDQ)
Timepoint [1] 320059 0
Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
Secondary outcome [1] 370386 0
Anxiety, Depression, Stress using Depression, Anxiety, Stress Scale (DASS-21)
Timepoint [1] 370386 0
Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
Secondary outcome [2] 370387 0
Pain Severity and pain-related interference using Brief Pain Inventory (BPI) short form
Timepoint [2] 370387 0
Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
Secondary outcome [3] 370388 0
Quality of life using EQ-5D-5L, five dimensions with five levels of severity
Timepoint [3] 370388 0
Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
Secondary outcome [4] 370389 0
Acceptance using Chronic pain acceptance questionnaire (CPAQ)
Timepoint [4] 370389 0
Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
Secondary outcome [5] 370390 0
Self-efficacy using Pain Self-efficacy Questionnaire (PSEQ)
Timepoint [5] 370390 0
Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
Secondary outcome [6] 370391 0
Catastrophising using Pain Catastrophising Scale (PCS)
Timepoint [6] 370391 0
Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
Secondary outcome [7] 370392 0
Self-as-Context using Self-Experience Questionnaire (SEQ)
Timepoint [7] 370392 0
Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
Secondary outcome [8] 370393 0
Fear of movement and reinjury - TAMPA Scale of Kinesiophobia (TSK-11)
Timepoint [8] 370393 0
Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
Secondary outcome [9] 370394 0
Healthcare use - Adapted from TiC-P questionnaire
Timepoint [9] 370394 0
Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
Secondary outcome [10] 370395 0
Current medications - Bespoke tool evaluating the use of prescription and over-the-counter pain, pain-related, antidepressant, and anxiolytic medications
Timepoint [10] 370395 0
Baseline. immediately after intervention (after 12 weeks), and 3 and 6 months post intervention.
Secondary outcome [11] 370396 0
Adherence to iSelf-help (Frequency and duration of website usage, Monitoring the participation in weekly interactive online group discussions)
Timepoint [11] 370396 0
During 12-week intervention period and till 6 months.
Secondary outcome [12] 370397 0
Acceptability of iSelf-help (Customised questionnaire)
Timepoint [12] 370397 0
At 12-weeks post intervention
Secondary outcome [13] 370688 0
Satisfaction of iSelf-help (customised questionnaire)
Timepoint [13] 370688 0
At 12-weeks post intervention

Eligibility
Key inclusion criteria
People with persistent, non-cancer pain referred for pain management at a tertiary pain management service from the lower half of the North Island and the upper half of the South Island, New Zealand,

Participants with any of the following persistent pain conditions will be included in the study:
• Persistent primary pain,
• Persistent musculoskeletal pain
• Persistent posttraumatic and postsurgical pain
• Persistent neuropathic pain,
• Persistent headache and orofacial pain
• Persistent visceral pain.

Inclusion criteria
(1) Adults with persistent non-cancer pain (defined above) aged 18 years and older,
(2) With daily access to a computer/smartphone at home, workplace or in a public location,
(3) Currently not experiencing any significant uncontrolled mental health condition
(4) Able to provide written informed consent.

We will provide internet subscription for the study period for those without internet access.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Participants with severe depression defined as >20 from the 7 items of Depression subscale of Depression, Anxiety, Stress Scale (DASS-21)53 and based on clinical evaluation by CCDHB pain management service.
(2) Primary cancer-related pain
(3) Planned surgical intervention for pain
(4) Concurrent participation in an additional multi-disciplinary group based pain management programme

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)
To ensure concealed allocation, a research team member will hold the randomisation sequence in sequentially numbered opaque sealed envelopes and will provide envelopes sequentially to the research assistant (outcome assessor) at the end of baseline assessment. Thus, the research assistant will be blinded to the allocation sequence, and the Assistant Research Fellow will ensure the envelopes are opened in the correct order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will then be block randomised (1:1) in to iSelf-help (intervention) and in-person (usual care) PMP groups with stratification by ethnicity (Maori or non-Maori) to ensure that both arms are similar in terms of ethnicity. The randomisation program (randomizer.org) will be used to generate a randomisation sequence in advance by our research team member not involved in recruitment, assessment or statistical analysis.
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
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size estimation: Trial sample size is calculated based on providing 80% power to detect non-inferiority using a 95% one-sided confidence interval. The margin for non-inferiority was a 3 points difference in changes on the RMDQ scale and assuming no actual difference in changes between the two treatment groups (iSelf-help and in-person PMP). From data reported in a previous trial of 471 participants with 397 excluding the wait-list control group,67 the standard deviation at baseline for RMDQ was approximately 5.0 (4.8–5.2 over the 4 groups), slightly higher at 3 months being around 5.7 (5.4–5.9 over the 3 groups with follow-up), and with correlations over 3 months of around r=0.5 (estimated from reported data to be 0.44–0.57 over the 3 groups with follow-up), giving a standard deviation for changes of 5.4. Allowing for a mean of 10 participants per group at baseline and a loss of 20% over the six months, so a mean of 8 participants per group at follow-up, with an ICC of 0.1 for RMDQ changes, design effects at follow-up are conservatively estimated to be 1.7. A total of n=70 participants would be needed in each group at six months follow-up. To allow for approximately 20% loss to follow-up, n=90 (9 groups) will be recruited into each arm of the study at baseline, n=180 (18 groups of 10) in total.

Statistical analyses: Baseline demographic and clinical characteristics will be described for participants in both groups. Linear mixed models will be used to model continuous outcomes (including RMDQ scores) collected over time (baseline, 12 weeks, 3 months, and 6 months) with random effects for participants and groups to accommodate the clustered data. For each model, an unstructured covariance matrix (and possibly other plausible structures if these are justified by theoretical considerations) for the longitudinal data will be investigated as an alternative to compound symmetry with selection based on Bayesian Information Criterion values. Marginal and conditional residuals will be investigated to ensure model assumptions are sufficiently well satisfied and natural logarithmic transformations of dependent variables investigated to see if this improves any problems with meeting these assumptions. If model assumptions cannot be satisfied through such transformations, quantile mixed models will be used for analyses instead, modelling medians. For count outcomes (including health care use), Poisson or, if there is overdispersion, negative binomial mixed models will be used. For any missing data, multiple imputation will be used for the initial analyses with pattern-mixture models used to explore plausible scenarios of informative missingness. The primary analysis will be guided by intention-to-treat principles to address the effectiveness question, but a secondary analysis will investigate the per protocol efficacy question for those attending at least 70% of their sessions. Success for the intervention will be demonstrated by non-inferiority in changes of RMDQ at 6 months for the effectiveness question. Statistical analyses will be conducted using R 3.4.2 (or later) with two-sided p<0.05 used for statistical significance and one-sided 95% confidence intervals used for non-inferiority.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21478 0
New Zealand
State/province [1] 21478 0
Wellington

Funding & Sponsors
Funding source category [1] 302704 0
Government body
Name [1] 302704 0
Health Research Council
Address [1] 302704 0
PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 302704 0
New Zealand
Primary sponsor type
Individual
Name
Prof Leigh Hale
Address
325 Great King Street, School of Physiotherapy,
University of Otago, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 302712 0
Individual
Name [1] 302712 0
Dr Hemakumar Devan
Address [1] 302712 0
23 Mein Street, School of Physiotherapy
University of Otago, Wellington 6242
Country [1] 302712 0
New Zealand
Secondary sponsor category [2] 302713 0
Individual
Name [2] 302713 0
Dr Meredith Perry
Address [2] 302713 0
23 Mein Street, School of Physiotherapy
University of Otago, Wellington 6242
Country [2] 302713 0
New Zealand
Other collaborator category [1] 280691 0
Individual
Name [1] 280691 0
Assoc Prof Rebecca Grainger
Address [1] 280691 0
23 Mein Street, Department of Medicine
University of Otago, Wellington 6242
Country [1] 280691 0
New Zealand
Other collaborator category [2] 280692 0
Individual
Name [2] 280692 0
Prof Edward Shipton
Address [2] 280692 0
University of Otago,
2 Riccarton Avenue
Christchurch Central
Christchurch 8011
New Zealand
Country [2] 280692 0
New Zealand
Other collaborator category [3] 280693 0
Individual
Name [3] 280693 0
Prof Anthony Dowell
Address [3] 280693 0
23 Mein Street, University of Otago, Wellington, 6242
Country [3] 280693 0
New Zealand
Other collaborator category [4] 280694 0
Individual
Name [4] 280694 0
Dr Tristram Ingham
Address [4] 280694 0
23 Mein Street, University of Otago, Wellington, 6242
Country [4] 280694 0
New Zealand
Other collaborator category [5] 280695 0
Individual
Name [5] 280695 0
Ms Bernadette Jones
Address [5] 280695 0
23 Mein Street, University of Otago, Wellington, 6242
Country [5] 280695 0
New Zealand
Other collaborator category [6] 280696 0
Individual
Name [6] 280696 0
Mr William Leung
Address [6] 280696 0
23 Mein Street, University of Otago, Wellington, 6242
Country [6] 280696 0
New Zealand
Other collaborator category [7] 280697 0
Individual
Name [7] 280697 0
Mr Andrew Gray
Address [7] 280697 0
Dean's Department,
Dunedin School of Medicine
Division of Health Sciences
Room 123, Adams Building, 18 Frederick Street, Dunedin 9016
New Zealand
Country [7] 280697 0
New Zealand
Other collaborator category [8] 280698 0
Individual
Name [8] 280698 0
Ms Barbara Saipe
Address [8] 280698 0
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
New Zealand
Country [8] 280698 0
New Zealand
Other collaborator category [9] 280699 0
Individual
Name [9] 280699 0
Ms Dagmar Hempel
Address [9] 280699 0
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
New Zealand
Country [9] 280699 0
New Zealand
Other collaborator category [10] 280700 0
Individual
Name [10] 280700 0
Ms Cheryl Davies
Address [10] 280700 0
Kokiri Marae
7-9 Barnes St,
Seaview,
Lower Hutt 5010
New Zealand
Country [10] 280700 0
New Zealand
Other collaborator category [11] 280701 0
Individual
Name [11] 280701 0
Prof Sarah Dean
Address [11] 280701 0
College House, University of Exeter,
St Luke's Campus,
Heavitree Road, Exeter, EX1 2LU, UK
Country [11] 280701 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303314 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 303314 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 303314 0
New Zealand
Date submitted for ethics approval [1] 303314 0
06/09/2018
Approval date [1] 303314 0
20/09/2018
Ethics approval number [1] 303314 0
18/CEN/162

Summary
Brief summary
The iSelf-help trial is a pragmatic, single-centred, assessor-blinded, randomised, two-arm, parallel group, non-inferiority study to compare the effectiveness of group-based, online-delivered pain management programme (iSelf-help) as compared to group-based in-person delivered pain management programme in reducing pain-related disability at 6-months. We hypothesise that group iSelf-help will not be less effective than an in-person group PMP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93238 0
Prof Leigh Hale
Address 93238 0
325 Great King Street, School of Physiotherapy,
University of Otago, Dunedin 9016
Country 93238 0
New Zealand
Phone 93238 0
+64 34795425
Fax 93238 0
Email 93238 0
leigh.hale@otago.ac.nz
Contact person for public queries
Name 93239 0
Dr Hemakumar Devan
Address 93239 0
School of Physiotherapy, University of Otago,
PO Box 7343, Newtown, Wellington, 6242
Country 93239 0
New Zealand
Phone 93239 0
+64 43855566
Fax 93239 0
Email 93239 0
hemakumar.devan@otago.ac.nz
Contact person for scientific queries
Name 93240 0
Dr Hemakumar Devan
Address 93240 0
School of Physiotherapy, University of Otago,
PO Box 7343, Newtown, Wellington, 6242
Country 93240 0
New Zealand
Phone 93240 0
+64 43855566
Fax 93240 0
Email 93240 0
hemakumar.devan@otago.ac.nz

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 published results only
When will data be available (start and end dates)?
Start date: 2/01/2023 (After publication)
No End date
Available to whom?
Only to researchers in this area
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
By emailing the prinicipal investigator of request.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2082 0
Informed consent form
Citation [1] 2082 0
Link [1] 2082 0
Email [1] 2082 0
Other [1] 2082 0
Type [2] 2088 0
Other
Citation [2] 2088 0
Link [2] 2088 0
Email [2] 2088 0
Other [2] 2088 0
Overview of contents of iSelf-help
Type [3] 2089 0
Ethical approval
Citation [3] 2089 0
Link [3] 2089 0
Email [3] 2089 0
Other [3] 2089 0
Ethical approval letter
Type [4] 2091 0
Other
Citation [4] 2091 0
Link [4] 2091 0
Email [4] 2091 0
Other [4] 2091 0
Overview of contents of in-person pain management programme
Summary results
No Results