Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001607460
Ethics application status
Approved
Date submitted
15/11/2016
Date registered
21/11/2016
Date last updated
3/05/2021
Date data sharing statement initially provided
17/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimal Aftercare for Stroke Survivors (OASiS): A randomised controlled trial of the effectiveness of an e-health innovation for stroke survivors and support persons
Scientific title
A randomised controlled trial of the effectiveness of 'Enable Me': an e-health innovation for stroke survivors and support persons.
Secondary ID [1] 290199 0
Nil known
Universal Trial Number (UTN)
Trial acronym
OASiS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 300357 0
Condition category
Condition code
Stroke 300224 300224 0 0
Haemorrhagic
Stroke 300771 300771 0 0
Ischaemic
Public Health 300805 300805 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group: Proactive engagement group
Survivor-support person dyads allocated to proactive engagement group will receive the materials including: Stroke Foundation’s “My Stroke Journey workbook”, a follow-up phone call from the Stoke Foundation from the Stroke Connect Service at 6 weeks post discharge from hospital and access to enableme web portal. The intervention group will receive access to the web portal online as required for the duration of the intervention period (6 months). The website includes information about stroke, treatments, forums for communications with others, and goal setting functions. Proactive strategies will be used throughout the intervention period to encourage use of the web portal. Proactive engagement strategies include: a letter from their stroke physicians, short message service (SMS) or email reminders to access the portal if usage is low, and letter which provides feedback regarding their use of the portal at 3 and 6 months.
Intervention code [1] 295957 0
Behaviour
Intervention code [2] 296100 0
Lifestyle
Comparator / control treatment
Control Group: Usual care group
Survivor-support person dyads allocated to the usual care group will receive usual care plus the Stroke Foundations “My Stroke Journey workbook”. Usual care may include referral to rehabilitation services. education and provision about Stroke Foundation resources. The enableme portal is publicly available, access will not be restricted. However, participants in usual care group will not receive prompts regarding access.
Control group
Active

Outcomes
Primary outcome [1] 299704 0
Depression (PQ-9) (Survivor)
Timepoint [1] 299704 0
Baseline, 3 and 6 months post-recruitment
Primary outcome [2] 299706 0
Quality of life (SF-12) (Survivor and Support Person)
Timepoint [2] 299706 0
Baseline, 3 and 6 months post-recruitment
Primary outcome [3] 300227 0
Depression (PQ-9) (Support Person)
Timepoint [3] 300227 0
Baseline, 3 and 6 months post-recruitment
Secondary outcome [1] 329285 0
Anxiety (GAD 7) (Survivor and SP)
Timepoint [1] 329285 0
Baseline, 3 and 6 months post-recruitment
Secondary outcome [2] 329286 0
Self efficacy (SSEQ4) (Survivor)
Timepoint [2] 329286 0
6 months post-recruitment
Secondary outcome [3] 329288 0
Longer-Term Unmet Needs After Stroke (LUNS) (Survivor)
Timepoint [3] 329288 0
Baseline, 3 and 6 months post-recruitment
Secondary outcome [4] 329289 0
Enableme acceptability (survivor and SP) will be assessed using likert type survey questions designed specifically for this study.
Timepoint [4] 329289 0
3 and 6 months post-recruitment

Eligibility
Key inclusion criteria
Survivors will be:
Patients admitted for stroke who are conscious and not requiring a high level of medical care are eligible to participate. They will be:
* aged 18 years or older,
* less than or equal to 3 months post first ischemic or haemorrhagic stroke or Transient Ischemic Attack,
* have access to the internet,
* have a mobile phone,
* being discharged home or to private rehabilitation services, and
* able to provide informed consent.

Support person will be:
* nominated by the stroke survivors as their primary source of practical and emotional support,
* aged 18 years or older,
* have access to the internet and
* have a mobile phone,
* able to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ineligible survivors will have:
* severe neurological impairment not associated with stroke;
* severe language or cognitive impairment; or
* insufficient English to complete measures.
* unable to access the internet/no phone.

Ineligible support persons:
* insufficient English to complete the study measures,
* unable to provide independent informed consent,
* unable to access the internet/no phone.

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)
Following completion of the baseline measures and consent for the RCT the survivor will be randomised to either: (1) usual care or (2) intervention, stratified by recruitment site. The randomisation schedule will be delivered in real time via secure web-based interface upon entering of the baseline survey. The randomisation allocation will be generated by the computer driven algorithm and displayed on-screen to the research assistant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation will be created dynamically with block sizes varying randomly. Allocation will be stratified based on treatment centre.
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
Age, type of stroke and stroke severity will be compared between consenters and non-consenters using a t-test (or a non-parametric equivalent) for continuous variables and the chi-square test (or fishers exact test) for categorical variables.
Characteristics of the stroke survivors and SPs will be compared between experimental groups using means, standard deviations, medians and interquartile intervals for continuous variables and by percentages for categorical variables.
Between-group differences in the proportion of depressed participants will be assessed at all post baseline study time points using separate logistic regressions for survivors and SPs.
Differences in quality of life at each post-randomisation period will be assessed using a linear regression model.
Multivariable linear mixed effects regression models will be used to identify whether use of Enable Me and/or patient demographic and diagnosis factors are associated with scores on the PHQ-9, or the SF-12.
Sample size: Using a conservative estimate (i.e. 70% of eligible survivor-patient dyads will consent), 850 dyads will be approached in order to recruit 600 dyads (300 dyads per group) at baseline. Allowing for 20% attrition by 3 months’ follow up and 30% by 6 months due to death, loss to follow up and study withdrawal, a sample of 240 per group at 3 month follow up, and 210 per group at 6 months follow up will be available. For depression, assuming a baseline prevalence of 30%, we will have 80% power to detect a prevalence difference of 10% at 3 months for survivors and less than 10% for SPs (assuming lower prevalence of depression in SPs) at the 2.5% significance level. For survivors and SPs we will have 80% power to detect differences between groups of 0.3 SD in QOL at 3 months and 0.33 SD at 6 months at a 2.5% significance level. Consent rates between 70% and 90% have been reported in previous studies in this population.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
30/11/2016
Actual
20/02/2017
Date of last participant enrolment
Anticipated
31/12/2019
Actual
22/11/2019
Date of last data collection
Anticipated
1/06/2020
Actual
15/05/2020
Sample size
Target
1200
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6709 0
Belmont Hospital - Belmont
Recruitment hospital [2] 6711 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 6712 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [4] 11035 0
Blacktown Hospital - Blacktown
Recruitment hospital [5] 11036 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [6] 11037 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [7] 11038 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [8] 11039 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 14350 0
2280 - Belmont
Recruitment postcode(s) [2] 14352 0
2298 - Waratah
Recruitment postcode(s) [3] 14353 0
2305 - New Lambton
Recruitment postcode(s) [4] 22831 0
2148 - Blacktown
Recruitment postcode(s) [5] 22832 0
2560 - Campbelltown
Recruitment postcode(s) [6] 22833 0
2450 - Coffs Harbour
Recruitment postcode(s) [7] 22834 0
2444 - Port Macquarie
Recruitment postcode(s) [8] 22835 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 294565 0
Government body
Name [1] 294565 0
National Health and Medical Research Council
Country [1] 294565 0
Australia
Funding source category [2] 294567 0
Government body
Name [2] 294567 0
Hunter New England Health District
Country [2] 294567 0
Australia
Funding source category [3] 294673 0
Charities/Societies/Foundations
Name [3] 294673 0
The Stroke Foundation
Country [3] 294673 0
Australia
Primary sponsor type
University
Name
Universtiy of Newcastle
Address
University Drive
Callaghan NSW 2289
Country
Australia
Secondary sponsor category [1] 293523 0
Charities/Societies/Foundations
Name [1] 293523 0
The Stroke Foundation
Address [1] 293523 0
Head Office
Level 7, 461 Bourke Street
Melbourne VIC 3000
Country [1] 293523 0
Australia
Secondary sponsor category [2] 293524 0
Government body
Name [2] 293524 0
Hunter New England Local Health District
Address [2] 293524 0
Lookout Road
New Lambton NSW 2305
Postal address:
Locked Bag 1
New Lambton NSW 2305
Country [2] 293524 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296001 0
Hunter New England Health Human Research Ethics Commitee
Ethics committee address [1] 296001 0
Ethics committee country [1] 296001 0
Australia
Date submitted for ethics approval [1] 296001 0
18/05/2016
Approval date [1] 296001 0
24/06/2016
Ethics approval number [1] 296001 0
16/05/18/4.04
Ethics committee name [2] 296327 0
Universtiy of Newcastle
Ethics committee address [2] 296327 0
Ethics committee country [2] 296327 0
Australia
Date submitted for ethics approval [2] 296327 0
01/07/2016
Approval date [2] 296327 0
08/07/2016
Ethics approval number [2] 296327 0
H-2016-0233

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

Contacts
Principal investigator
Name 69206 0
Prof Rob Sanson-Fisher
Address 69206 0
Priority Research Centre for Health Behaviour
W4 HMRI Building
School of Medicine and Public Health
University of Newcastle
University Drive
Callaghan NSW 2308
Australia
Country 69206 0
Australia
Phone 69206 0
+61240420713
Fax 69206 0
Email 69206 0
[email protected]
Contact person for public queries
Name 69207 0
Rob Sanason-Fisher
Address 69207 0
Priority Research Centre for Health Behaviour
W4 HMRI Building
School of Medicine and Public Health
University of Newcastle
University Drive
Callaghan NSW 2308
Australia
Country 69207 0
Australia
Phone 69207 0
+61240420713
Fax 69207 0
Email 69207 0
[email protected]
Contact person for scientific queries
Name 69208 0
Rob Sanson-Fisher
Address 69208 0
Priority Research Centre for Health Behaviour
W4 HMRI Building
School of Medicine and Public Health
University of Newcastle
University Drive
Callaghan NSW 2308
Australia
Country 69208 0
Australia
Phone 69208 0
+61240420713
Fax 69208 0
Email 69208 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
Data from this study are not publicly available because of ethical restrictions on data sharing due to the need to protect patient confidentiality. Under the terms of our approval, it is required that access to data is restricted to study personnel only. Additional use of or access to the data requires that the research team submit a request for variation of ethics approval.


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.