A phase II multicentered, single-blind, randomized, controlled trial of the stroke self-management program

Area of Science:

• Neurology
• Rehabilitation Medicine
• Chronic Disease Management

Background:

• Chronic disease self-management programs' benefits for stroke survivors are unclear, as severe impairment cases are often excluded.
• A phase II randomized controlled trial was conducted to address this gap.

Purpose of the Study:

• To determine the safety and feasibility of a stroke-specific self-management program (SSMP) compared to standard care and a generic program.
• To assess participation, safety, engagement, quality of life, and mood in stroke survivors.

Main Methods:

• 143 stroke survivors were randomized (1:1:1) into SSMP, generic self-management, or control groups.
• Primary outcomes included recruitment, participation, and safety; secondary outcomes assessed life engagement, quality of life, and mood at 6 months post-intervention.
• 41% of participants had severe cognitive impairment.

Main Results:

• The SSMP was safe and feasible, with no adverse events attributable to the interventions.
• Participation and completion rates were higher for the SSMP (52%) compared to the generic program (38%).
• Potential benefits for improved mood were observed.

Conclusions:

• The stroke-specific self-management program (SSMP) is safe and feasible for stroke survivors, including those with severe impairments.
• The SSMP demonstrated superior participation and completion rates compared to a generic program.
• An efficacy trial is recommended due to the growing stroke population and survival trends.