Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001205325p
Ethics application status
Submitted, not yet approved
Date submitted
21/07/2017
Date registered
17/08/2017
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Prevent Second Stroke (P2S): A randomised controlled trial of stroke survivors testing an online program to improve quality of life.
Scientific title
Healthy living after stroke: An online intervention for improving stroke
survivor health behaviours and quality of life
Secondary ID [1] 291573 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 302671 0
Nicotine Addiction 302674 0
Poor diet quality 302675 0
Alcohol consumption 302676 0
Physical inactivity 302677 0
Anxiety
 304211 0
Stroke 304419 0
Condition category
Condition code
Stroke 303555 303555 0 0
Haemorrhagic
Stroke 303556 303556 0 0
Ischaemic
Diet and Nutrition 303557 303557 0 0
Other diet and nutrition disorders
Mental Health 303558 303558 0 0
Anxiety
Mental Health 303559 303559 0 0
Depression
Mental Health 303560 303560 0 0
Addiction
Cardiovascular 303561 303561 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individuals in the intervention group will receive access to an online program called Prevent Second Stroke (P2S). Individuals will be advised to access the program at least once a week, with a training video on how to use the program presented to the individual on first use. Individuals will have access to the online program for 12 weeks, and will be able to access 24 hours a day, 7 days a week during that time.
P2S contains evidence-base techniques and information in six core modules: 1) Blood Pressure, 2) Smoking, 3) Alcohol, 4) Activity, 5) Nutrition, and 6) Feelings and Mood available as icons across the top of the screen, along with Home and My Progress icons. Each health risk behaviour module commences with 2-3 brief questions regarding the topic of interest (e.g., Blood Pressure: their last blood pressure reading and when they were last screened; Smoking: smoking status, how many cigarettes per day, interest in quitting) in order to provide tailored information to the user. Each module will take approximately 20-30 minutes to complete. Participants will be asked to set a specific goal at the end of each module and will be provided with information and advice on how to achieve the goal. The information contained in each module is in the form of videos and text based information. Individuals will also be provided with other useful website links to more information. The advice in each module is tailored to accommodate stroke-related symptoms.
Timing data will be collected from the online platform which hosts the program regarding the time spent on program modules. Fortnightly texts and emails will be sent to prompt program access. At present there are no plans to have a member of the research team checking fidelity or adherence to the program, with no plans at present made to analyse timing data.
Intervention code [1] 297637 0
Behaviour
Intervention code [2] 298753 0
Treatment: Other
Intervention code [3] 298754 0
Lifestyle
Comparator / control treatment
Participants randomised to the minimal ethical care control group will receive a letter with the web addresses of readily available, generic online health programs designed for the general population (e.g., Department of Health ‘Quit Now’; ‘Eat for Health’ sites; the MOODGym site).
Control group
Active

Outcomes
Primary outcome [1] 301612 0
Quality of Life (EuroQuol-5 Dimensions [EQ-5D-5L])
Timepoint [1] 301612 0
Baseline, 6 and 12 months
Secondary outcome [1] 333289 0
Cost-effectiveness (Client Service Receipt Inventory [CSRI])
Timepoint [1] 333289 0
6 and 12 months
Secondary outcome [2] 333290 0
Depression and anxiety levels (Patient Health Questionnaire for Depression and Anxiety [PHQ-4])
Timepoint [2] 333290 0
Baseline, 6 and 12 months
Secondary outcome [3] 333291 0
Physical functioning and independent living (Activities of Daily Living [ADL]
Timepoint [3] 333291 0
Baseline, 6 and 12 months
Secondary outcome [4] 333292 0
Smoking status (Heaviness of Smoking Index (HSI))
Timepoint [4] 333292 0
Baseline, 6 and 12 months
Secondary outcome [5] 333293 0
Alcohol consumption (Alcohol Use Disorders. Identification Test – Consumption [AUDIT-C])
Timepoint [5] 333293 0
Baseline, 6 and 12 months
Secondary outcome [6] 333294 0
Diet quality (Australian Recommended Food Score [ARFS])
Timepoint [6] 333294 0
Baseline, 6 and 12 months
Secondary outcome [7] 333295 0
Physical activity (Godin Leisure Time Exercise Questionnaire [GTLEQ])
Timepoint [7] 333295 0
Baseline, 6 and 12 months
Secondary outcome [8] 337433 0
Instrumental Activities of Daily Living [IADL] scales)
Timepoint [8] 337433 0
Baseline, 6 & 12 months
Secondary outcome [9] 337437 0
hospital re-admission for all causes (using medical records data)
Timepoint [9] 337437 0
6 and 12 months.

Eligibility
Key inclusion criteria
1) admitted to an Australian Stroke Clinical Registry (AuSCR) hospital for first episode of care for acute stroke or other indexed stroke event (ischaemic, haemorrhagic, TIA, or undetermined types of stroke will be included) at 6 – 36 months post stroke;
2) sufficiently fluent in English; and
3) sufficiently fluent in internet use via a home device (e.g. computer or tablet device) or willing to use public internet services (e.g. public library).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) been admitted with a subsequent stroke event (second to the indexed stroke event) or documented evidence of a previous stroke; or
2) experienced disability at a level that may limit their use of the program (determined using a score of >2 in the modified Rankin Score.

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)
A computer random number generator embedded in the computer assisted telephone interview (CATI) software will be used to allocate study participants to either receive the intervention or standard care, once all baseline questions have been answered.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Individuals will be randomised in permuted blocks of randomly varying size (e.g. 4 and 6), stratified by state (New South Wales, Queensland, Western Australia and Victoria/Tasmania), and type of stroke (ischaemic, haemorrhagic, TIA). The block size will be masked from all except the statistician.
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
The distribution of all variables will be checked for normality, with non-parametric statistics used when appropriate. The age and gender of participants will be compared to that of the non-responders (AuSCR database) to investigate the representativeness of the study sample.
A full Statistical Analysis Plan will be written prior to the completion of data collection.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/09/2017
Actual
Date of last participant enrolment
Anticipated
31/03/2019
Actual
Date of last data collection
Anticipated
31/03/2020
Actual
Sample size
Target
530
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296063 0
Government body
Name [1] 296063 0
National Health and Medical Research Council
Country [1] 296063 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
1 University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 294954 0
None
Name [1] 294954 0
Address [1] 294954 0
Country [1] 294954 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 297320 0
University of Newcastle Human Ethics Comittee
Ethics committee address [1] 297320 0
1 University Drive
Callaghan NSW 2308
Ethics committee country [1] 297320 0
Australia
Date submitted for ethics approval [1] 297320 0
28/02/2017
Approval date [1] 297320 0
Ethics approval number [1] 297320 0

Summary
Brief summary
The primary aim of the trial is to examine, using a randomised controlled trial, the effectiveness of an online healthy recovery intervention program (“Prevent 2nd Stroke”[P2S]) in improving health-related quality of life amongst stroke survivors at 6 months follow-up. Stroke survivors will be recruited from the The Australian Stroke Clinical Registry (AuSCR) database which contains the contact information of individuals who have had a stoke or TIA (indexed stroke event). Individuals assigned to the intervention group will receive 12 weeks access to the P2S program which they are able to to use to help improve their health behaviours and health outcomes.
P2S is an online health behaviour change program containing six modules: 1) Blood Pressure, 2) Smoking, 3) Alcohol, 4) Activity, 5) Nutrition, and 6) Feelings and Mood. The program is interactive and tailored to accommodate stroke-related symptoms. Goals and progress will be monitored and graphed and will be available to the user in a ‘My Progress’ section of the program.
at 6 and 12 months follow-up, health-related quality of life will be determined, as too will be:
a) depression and anxiety levels;
b) self-reported physical functioning and independent living;
c) four health risk behaviours (smoking cessation, reduction in alcohol use, diet quality, and increase in moderate physical activity), and;
d) hospital admission for recurrent stroke, myocardial infarction and all causes

Cost-effectiveness of the intervention will also be determined at 6 and 12 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73694 0
Prof Billie Bonevski
Address 73694 0
The University of Newcastle
1 University Drive
Callaghan NSW
Australia
2308
Country 73694 0
Australia
Phone 73694 0
+61 240 335 710
Fax 73694 0
Email 73694 0
billie.bonevski@newcastle.edu.au
Contact person for public queries
Name 73695 0
Dr Olivia Wynne
Address 73695 0
The University of Newcastle
1 University Drive
Callaghan NSW
Australia
2308
Country 73695 0
Australia
Phone 73695 0
+61 240 335 705
Fax 73695 0
Email 73695 0
olivia.wynne@newcastle.edu.au
Contact person for scientific queries
Name 73696 0
Dr Olivia Wynne
Address 73696 0
The University of Newcastle
1 University Drive
Callaghan NSW
Australia
2308
Country 73696 0
Australia
Phone 73696 0
+61 240 335 705
Fax 73696 0
Email 73696 0
olivia.wynne@newcastle.edu.au

No information has been provided regarding IPD availability


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.