‘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

Abstract

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.