None listed
Conditions
Brief summary
Each year 53,000 Australians have a stroke and 88% return home to the community. Stroke survivors struggle to recover quality of life at home.Self management programs are a new initiative designed to help people living with a chronic condition manage their day to day lives more effectively, improve quality of life and live a more healthy lifestyle. In 2004/06, the National Stroke Foundation developed and piloted a stroke self management program. The Phase 1 trial demonstrated positive outcomes for the participants. The aim of this Phase 2 trial is to test the proposed research protocol and outcome measures, whilst validating the effect size calculation in preparation for a Phase 3 larger RCT. Participants will be recruited from six hospitals in Adelaide with a letter from the HEad of the Stroke Unit, through advertising in local Adelaide newspapers, through Stroke SA, general practice or word of mouth. Stroke survivors returning home or already living in the community,3/12 after their stroke will be invited to participate. Participants will be randomly allocated to one of three groups: The first group, "Standard Care" will receive their usual care when they are discharged from hospital. They may be managed by their GP, referred to community services, given information about life after stroke, or join a stroke support group. The second group will receive usual care and undertake the Chronic Condition Self Management Program. This generic, six week education program runs with a range of disease groups including stroke. The third group will receive usual care and undertake the Stroke Self Management Program. This eight week education program is designed to help "get life back on track" after stroke. All participants will be assessed prior to admission to the program, at 6-8 weeks and at 6 months. The assessor will be unaware of the group allocation. The primary outcome measure is improvements in positive and active engagement in life as measured by the hei-Q. The hei-Q is designed to measures changes in self management programs. Improvements in quality of life, mood and cost benefits are secondary outcomes. This is the first time in the world that the impact of cognition, language and physical disability on a person's ability to self manage will be explored. An accurate record of adverse events shall be maintained. Participants will be informed of their right to withdraw at any time without prejudice
Interventions
Intervention 1 - Chronic Condition Self Management Program. Participants will receive usual care and undertake the
Chronic Condition Self Management Program. This generic education
program runs with a range of disease groups including stroke. Participants will attend the program 1 x 2.5 hr session per week for six weeks. The program involves presentations, group activities and hand outs.
Intervention 2 - Stroke Self Management Program. Participants will receive usual care and undertake the Stro
Intervention 1 - Chronic Condition Self Management Program. Participants will receive usual care and undertake the Chronic Condition Self Management Program. This generic education program runs with a range of disease groups including stroke. Participants will attend the program 1 x 2.5 hr session per week for six weeks. The program involves presentations, group activities and hand outs. Intervention 2 - Stroke Self Management Program. Participants will receive usual care and undertake the Stroke Self Management Program. This stroke specific, education program is designed to help "get life back on track" after stroke. Participants will attend the program 1 x 2.5 hr session per week for eight weeks. The program involves presentations, group activities and hand outs.
Sponsors
National Stroke Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1/ Participants 18 years and over with a clinical diagnosis of stroke. (Participants who have had a previous stroke will be included in the study) 2/ Participants must be living in the community or have the capacity to return to living in the community. 3/ Participants must be at least 3 months post stroke event. 4/ Participants may have cognitive impairment 5/ Participants may have language difficulties. 6/ Participants may be living independently or assisted by a carer (or carers). (The carer may attend in the self management program.)
Exclusion criteria
1/ Previous participation in any type of Self Management Program. 2/ People who live or will live in an aged care facility prior to commencement of the study 3/ Patients who are not able or willing to attend a self management program for 2.5 hours per week for up to 8 weeks. 4/ Patient for whom English is a second language
Outcome results
None listed