None listed
Conditions
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) or the Hunter Stroke Research Volunteer Register (HSRVR) databases which contain 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 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 months.
Interventions
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
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.
Sponsors
University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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) OR are registered with the Hunter Stroke Research Volunteer Register (HSRVR) 2) are between 6 – 36 months post stroke; 3) sufficiently fluent in English; and 4) 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).
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 to >3 in the modified Rankin Score).
Outcome results
None listed