Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000788875p
Ethics application status
Submitted, not yet approved
Date submitted
27/04/2021
Date registered
23/06/2021
Date last updated
23/06/2021
Date data sharing statement initially provided
23/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of heated gloves for Raynaud’s Phenomenon in Scleroderma patients
Scientific title
Use of heated gloves for Raynaud’s Phenomenon in Systemic Sclerosis
Secondary ID [1] 304038 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic sclerosis 321669 0
Raynaud's Phenomenon 322252 0
Condition category
Condition code
Inflammatory and Immune System 319416 319416 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A cross-over randomised controlled trial design will be used with the interventions being: (a) use of electric gloves, or (b) routine practice each for 4 weeks with 1 week ‘washout’ between study periods. The trial will take place during the Adelaide winter months of July to Sept. It will not be blinded. Rheumatologists working in a dedicated Systemic Sclerosis clinic will recruit and administer the trial.
Participants can choose any of three settings designated low (38ºC), medium (47 ºC), or high (55ºC). The gloves have slimline rechargeable batteries and provide >5 hours heat on the lowest setting. This is a pragmatic trial and participants will choose the frequency and duration of time wearing the gloves. They will keep a daily Raynaud’s Attack Diary which will record the number of attacks, the duration of each and whether or not gloves were worn during an attack. Participants will also complete a Raynaud’s Condition Score which asks the extent of difficulty with Raynaud’s each day.
Intervention code [1] 320401 0
Treatment: Devices
Comparator / control treatment
The participant's usual practice, which may involve gloves (not heated). This will be a 4-week period. No specific instructions eg avoidance of heated hand warmers will be made as this is a pragmatic trial.
Control group
Active

Outcomes
Primary outcome [1] 327342 0
Raynaud’s Condition Score (RCS)
Timepoint [1] 327342 0
Recorded daily for 4 weeks post commencement of treatment period.
Secondary outcome [1] 394648 0
The Raynaud’s Attack diary provides a measure of the frequency and duration of Raynaud’s attacks. This has been used in clinical drug trials and these reports supply the means and Standard Deviations for number and duration of attacks. It will also record whether or not the heated gloves were being worn at the time of an attack.
There will also be a measure of satisfaction with wearing the gloves and the question “Do you intend to continue wearing the gloves after the trial?”
Timepoint [1] 394648 0
Recorded daily for 4 weeks post commencement of treatment period.

Eligibility
Key inclusion criteria
i. Raynaud’s phenomenon secondary to SSc, with or without digital ulcers
ii. If currently taking medications for Raynaud’s therapy (calcium channel blockers, sildenafil, endothelin receptor antagonists), the dose must have been stable for at least 4 weeks
iii. Willingness to try heated gloves
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Severe joint contractures or severe complicated digital ulcers (eg with infection and/or discharge) preventing comfortable use of heated gloves
ii. Sensory impairment eg peripheral neuropathy with loss of heat sensation
iii. Any physical or psychiatric illness which the investigator deems would render participation in the trial unsafe or impractical.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics will be analysed descriptively (using means and standard deviations or medians and interquartile ranges for continuous variables; and using frequencies and percentages for categorical variables).
Paired Students’ T-test will be used to determine the difference in means between the two treatment groups.
Secondary and exploratory outcomes will be analysed descriptively and also by using logistic and linear regression models, as appropriate.
For all outcomes, statistical significance will be assessed at the 0.05 level (two-sided). In addition to effect estimates and p-values, 95% confidence intervals will be reported to express uncertainty about the estimated effects.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
Date of last participant enrolment
Anticipated
1/09/2021
Actual
Date of last data collection
Anticipated
1/10/2021
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 19217 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 33790 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 308421 0
Charities/Societies/Foundations
Name [1] 308421 0
Bequest administered by the Health Services Charitable Gifts Board
Country [1] 308421 0
Australia
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network
Address
Royal Adelaide Hospital
Port Rd, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 309255 0
None
Name [1] 309255 0
Address [1] 309255 0
Country [1] 309255 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308382 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 308382 0
Level 3, Roma Mitchell House
136 North Terrace
Adelaide, South Australia, 5000
Ethics committee country [1] 308382 0
Australia
Date submitted for ethics approval [1] 308382 0
03/05/2021
Approval date [1] 308382 0
Ethics approval number [1] 308382 0

Summary
Brief summary
Overview: Raynaud's Phenomenon is characterised by spasms of blood vessels in the peripheries and in both hands and feet it can lead to pain, ulceration, and amputation of fingers and toes. It is a common feature of the autoimmune disease, Systemic Sclerosis. The pain and difficulty in using the fingers creates substantial limitations on everyday activities with subsequent decrease in the quality of daily living. A patient of one of the investigators had the initiative to try electrically heated gloves and found them "life changing". This project is a pragmatic clinical trial to examine the usefulness of heated gloves for these patients.
Participants will have Raynaud's Phenomenon secondary to Systemic Sclerosis.
A cross-over randomised controlled trial design will be used with the interventions being: (a) use of electrically heated gloves, or (b) routine practice. The trial will take place during the Adelaide winter months of July to Sept.
The objective of the trial is to determine whether use of electrically heated gloves improves quality of life for patients with Raynaud's Phenomenon compared to their usual practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110518 0
Prof Susanna Proudman
Address 110518 0
Rheumatology Unit
Royal Adelaide Hospital
Port Rd
Adelaide SA 5000
Country 110518 0
Australia
Phone 110518 0
+61 08 70742779
Fax 110518 0
Email 110518 0
[email protected]
Contact person for public queries
Name 110519 0
Prof Susanna Proudman
Address 110519 0
Rheumatology Unit
Royal Adelaide Hospital
Port Rd
Adelaide SA 5000
Country 110519 0
Australia
Phone 110519 0
+61 08 70742779
Fax 110519 0
Email 110519 0
[email protected]
Contact person for scientific queries
Name 110520 0
Prof Susanna Proudman
Address 110520 0
Rheumatology Unit
Royal Adelaide Hospital
Port Rd
Adelaide SA 5000
Country 110520 0
Australia
Phone 110520 0
+61 08 70742779
Fax 110520 0
Email 110520 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?
Case level data for the Primary and Secondary Outcomes.
When will data be available (start and end dates)?
Dec 1st 2021 with no end date.
Available to whom?
Researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Investigator
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
Via contacting the Principle 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
No additional documents have been identified.