Developing complex interventions: Lessons learned from a pilot study examining strategy training in acute stroke rehabilitation

Abstract

Objective: To examine the feasibility of a strategy training clinical trial in a small group of adults with stroke-related cognitive impairments in inpatient rehabilitation, and to explore the impact of strategy training on disability. Design: Non-randomized two-group intervention pilot study. Setting: Two inpatient rehabilitation units within an academic health centre. Participants: Individuals with a primary diagnosis of acute stroke, who were admitted to inpatient rehabilitation and demonstrated cognitive impairments were included. Individuals with severe aphasia; dementia; major depressive disorder, bipolar, or psychotic disorder; recent drug or alcohol abuse; and anticipated length of stay less than five days were excluded. Intervention: Participants received strategy training or an attention control session in addition to usual rehabilitation care. Sessions in both groups were 30-40 minutes daily, five days per week, for the duration of inpatient rehabilitation. Main outcome measures: We assessed feasibility through participants' recruitment and retention; research intervention session number and duration; participants' comprehension and engagement; intervention fidelity; and participants' satisfaction. We assessed disability at study admission, inpatient rehabilitation discharge, 3 and 6 months using the Functional Independence Measure. Results: Participants in both groups (5 per group) received the assigned intervention (>92% planned sessions; >94% fidelity) and completed follow-up testing. Strategy training participants in this small sample demonstrated significantly less disability at six months (M (SE) = 117 (3)) than attention control participants (M(SE) = 96 (14); t8 = 7.87, P = 0.02). Conclusions: It is feasible and acceptable to administer both intervention protocols as an adjunct to acute inpatient rehabilitation, and strategy training shows promise for reducing disability. © The Author(s) 2013.