Getting your life back on track after stroke : a phase II multi-centered, single-blind, randomized, controlled trial of the Stroke Self-Management Program vs. the Stanford Chronic Condition Self-Management Program or standard care in stroke survivors

Battersby, M., Hoffmann, S., Cadilhac, D., Osborne, R., Lalor, E. and Lindley, R. 2009, Getting your life back on track after stroke : a phase II multi-centered, single-blind, randomized, controlled trial of the Stroke Self-Management Program vs. the Stanford Chronic Condition Self-Management Program or standard care in stroke survivors, International journal of stroke, vol. 4, no. 2, pp. 137-144.

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Title Getting your life back on track after stroke : a phase II multi-centered, single-blind, randomized, controlled trial of the Stroke Self-Management Program vs. the Stanford Chronic Condition Self-Management Program or standard care in stroke survivors
Author(s) Battersby, M.
Hoffmann, S.
Cadilhac, D.
Osborne, R.
Lalor, E.
Lindley, R.
Journal name International journal of stroke
Volume number 4
Issue number 2
Start page 137
End page 144
Total pages 8
Publisher Blackwell Publishing
Place of publication Oxford, England
Publication date 2009-04
ISSN 1747-4930
1747-4949
Keyword(s) patient education
Phase II trial
quality of life
self-management
stroke
Summary Background Self-management is seen as a primary mechanism to support the optimization of care for people with chronic diseases such as symptomatic vascular disease. There are no established and evidence-based stroke-specific chronic disease self-management programs. Our aim is to evaluate whether a stroke-specific program is safe and feasible as part of a Phase II randomized-controlled clinical trial.
Methods Stroke survivors are recruited from a variety of sources including: hospital stroke services, local paper advertisements, Stroke South Australia newsletter (volunteer peer support organization), Divisions of General Practice, and community service providers across Adelaide, South Australia. Subjects are invited to participate in a multi-center, single-blind, randomized, controlled trial. Eligible participants are randomized to either;
• standard care,
• standard care plus a six week generic chronic condition self-management group education program, or,
• standard care plus an eight week stroke specific self-management education group program.
Interventions are conducted after discharge from hospital. Participants are assessed at baseline, immediate post intervention and six months.
Study Outcomes The primary outcome measures determine study feasibility and safety, measuring, recruitment, participation, compliance and adverse events.
Secondary outcomes include:
• positive and active engagement in life measured by the Health Education Impact Questionnaire,
• improvements in quality of life measured by the Assessment of Quality of Life instrument,
• improvements in mood measured by the Irritability, Depression and Anxiety Scale,
• health resource utilization measured by a participant held diary and safety.

Conclusion The results of this study will determine whether a definitive Phase III efficacy trial is justified.
Language eng
Field of Research 110904 Neurology and Neuromuscular Diseases
Socio Economic Objective 920205 Health Education and Promotion
HERDC Research category C1.1 Refereed article in a scholarly journal
Copyright notice ©2009, Blackwell Publishing
Persistent URL http://hdl.handle.net/10536/DRO/DU:30023834

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