Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001094268
Ethics application status
Approved
Date submitted
25/06/2018
Date registered
29/06/2018
Date last updated
8/02/2019
Date data sharing statement initially provided
8/02/2019
Date results information initially provided
8/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Research study on information about experimental stem cell treatments for stroke
Scientific title
Effectiveness of patient education in changing stroke survivor attitudes toward unregulated and experimental stem cell treatments: A randomized controlled trial
Secondary ID [1] 295311 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Stroke 308501 0
Condition category
Condition code
Stroke 307474 307474 0 0
Ischaemic
Stroke 307475 307475 0 0
Haemorrhagic
Public Health 307513 307513 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be conducted online. Participants will be randomly allocated to one of two intervention groups (Arm 1, 2) or one control group (Arm 3: discussed in the next section). First, participants in Arms 1 and 2 will be asked to provide some background information (e.g., age, gender, stroke type/year) and details of their current physical, cognitive and emotional functioning. Immediately after this, participants will be asked to complete a brief survey (6 questions) about experimental stem cell treatments (e.g. perceived risks, benefits, accessibility, affordability).
Arm 1:
Participants in Arm 1 will then be directed via a web link to an information booklet produced by the International Society for Stem Cell Research (ISSCR). Topics covered in the booklet include: what are stem cells, the risks and benefits associated with different types of stem cell treatments, and the difference between treatments offered by private clinics and those offered within clinical trials. The booklet is expected to take approximately 30 minutes to read and participants will need to do so at that time. After confirming that they have read the booklet, participants will be asked to recomplete the previous survey about experimental stem cell treatments. The first stage of the study ends here for Arm 1. Participants will then be emailed 30-days after completing this stage to reconfirm their attitudes toward experimental stem cell treatments by completing the previously administered survey.
Arm 2:
Participants in Arm 2 will then be directed via a web link to watch a patient information video (1.17 minutes in length) produced by the Stem Cell Network. Topics covered in the video include: the current state of stem cell treatment research, the risks associated with having experimental stem cell treatments, and how researchers and regulatory bodies determine if treatments are safe and effective for patients to use. After confirming that they have watched the video, participants will be asked to recomplete the previous survey about experimental stem cell treatments. The first stage of the study ends here for Arm 2. Participants will then be emailed 30-days after completing this stage to reconfirm their attitudes toward experimental stem cell treatments by completing the previously administered survey.
Intervention code [1] 301640 0
Behaviour
Comparator / control treatment
Participants in Arm 3 will be asked to provide the same background information (e.g., age, gender, stroke type/year) and details of their current physical, cognitive and emotional functioning as Arms 1 and 2. Participants will also be asked to complete a brief survey (6 questions) about experimental stem cell treatments (e.g. perceived risks, benefits, accessibility, affordability). Following this, participants in Arm 3 will not be required to read or view any resources. Instead, they will be emailed 30-days after providing their initial responses to reconfirm their attitudes toward experimental stem cell treatments by completing the previously administered survey. Once this has been completed, participants in Arm 3 will be provided with web links to the booklet and video given to Arms 1 and 2.
Control group
Active

Outcomes
Primary outcome [1] 306450 0
Perceived level of safety/risk associated with having experimental stem cell treatments (assessed by study-specific survey).
Timepoint [1] 306450 0
Pre-intervention (baseline), immediately post-intervention (primary endpoint) and 30-days post-intervention.
Primary outcome [2] 306495 0
Perceived effectiveness of experimental stem cell treatments (assessed by study-specific survey).
Timepoint [2] 306495 0
Pre-intervention (baseline), immediately post-intervention (primary endpoint) and 30-days post-intervention.
Primary outcome [3] 306496 0
Perceived accessibility of experimental stem cell treatments (assessed by study-specific survey).
Timepoint [3] 306496 0
Pre-intervention (baseline), immediately post-intervention (primary endpoint) and 30-days post-intervention.
Secondary outcome [1] 348590 0
Primary outcome [4]: Perceived affordability of experimental stem cell treatments (assessed by study-specific survey).
Timepoint [1] 348590 0
Pre-intervention (baseline), immediately post-intervention (primary endpoint) and 30-days post-intervention.

Eligibility
Key inclusion criteria
English-speaking, adult, stroke survivors who have not previously had experimental stem cell injections, either as a treatment for their stroke/stroke-related symptoms (e.g. pain), or any other medical or neurological disorder, and who are able to provide consent (personally or via a third party).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stroke survivors aged less than 18 years (at time of survey) and/or have previously had experimental stem cell injections, either as a treatment for their stroke/stroke-related symptoms (e.g. pain), or other medical or neurological disorder.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will contact the holder of the allocation schedule (via email) who will be located at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A 3 x 3 mixed model analysis of variance (ANOVA) will be conducted to statistically compare the mean response scores for the patient information booklet (Arm 1), patient information video (Arm 2), and control (Arm 3) groups for four assessable items (perceived safety, effectiveness, accessibility, affordability of experimental stem cell treatments) across the three time points (i.e. pre-intervention, immediately post-intervention, 30-day post-intervention).

A minimum of 108 participants (i.e. 36 respondents per Arm) will be required to detect moderate effect sizes (F statistics greater than or equal to 0.25) between the three groups (patient information booklet, video, control) across three time points (pre-intervention, immediately post-intervention, 30-days post-intervention), with 80% chance at an alpha level of .05. However, allowing for an estimated 30% attrition rate (estimate based on previous survey), 159 participants will be recruited initially (i.e. 53 respondents per group).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/06/2018
Actual
29/06/2018
Date of last participant enrolment
Anticipated
1/01/2019
Actual
1/01/2019
Date of last data collection
Anticipated
1/02/2019
Actual
1/02/2019
Sample size
Target
159
Accrual to date
Final
222
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 10632 0
United States of America
State/province [1] 10632 0
Country [2] 10633 0
United Kingdom
State/province [2] 10633 0
Country [3] 10634 0
Canada
State/province [3] 10634 0

Funding & Sponsors
Funding source category [1] 299900 0
University
Name [1] 299900 0
University of Adelaide
Country [1] 299900 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace
Adelaide South Australia 5005
Country
Australia
Secondary sponsor category [1] 299265 0
None
Name [1] 299265 0
Address [1] 299265 0
Country [1] 299265 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300770 0
University of Adelaide Human Research Ethics Committee [EC00195]
Ethics committee address [1] 300770 0
Level 4, Rundle Mall Plaza
50 Rundle Mall
Adelaide South Australia 5000
Ethics committee country [1] 300770 0
Australia
Date submitted for ethics approval [1] 300770 0
15/03/2018
Approval date [1] 300770 0
18/06/2018
Ethics approval number [1] 300770 0
H-2018-128

Summary
Brief summary
This research study is examining whether patient education booklets and videos are a clear and informative way of communicating information about the safety, effectiveness, accessibility and affordability of experimental stem cell treatments (i.e. stem cell injections to the brain, spinal cord, vein, artery or stomach) offered by private clinics in China, India, Russia and South America.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2809 2809 0 0
/AnzctrAttachments/375425-Human Research Ethics Approval_H-2018-128.pdf (Ethics approval)
Attachments [2] 2810 2810 0 0
/AnzctrAttachments/375425-Participant Information Sheet.pdf (Participant information/consent)

Contacts
Principal investigator
Name 84758 0
Dr Diana Dorstyn
Address 84758 0
University of Adelaide
Faculty of Health and Medical Sciences
North Terrace
Adelaide South Australia 5000
Country 84758 0
Australia
Phone 84758 0
+61 8 8313-5266
Fax 84758 0
Email 84758 0
diana.dorstyn@adelaide.edu.au
Contact person for public queries
Name 84759 0
Mr David Unsworth
Address 84759 0
University of Adelaide
Faculty of Health and Medical Sciences
North Terrace
Adelaide South Australia 5000
Country 84759 0
Australia
Phone 84759 0
+61 8 8313-3452
Fax 84759 0
Email 84759 0
david.unsworth@adelaide.edu.au
Contact person for scientific queries
Name 84760 0
Mr David Unsworth
Address 84760 0
University of Adelaide
Faculty of Health and Medical Sciences
North Terrace
Adelaide South Australia 5000
Country 84760 0
Australia
Phone 84760 0
+61 8 8313-3452
Fax 84760 0
Email 84760 0
david.unsworth@adelaide.edu.au

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.