Article

OBJECTIVE: To assess the feasibility of conducting a randomized controlled trial
of an instructional and educational stroke DVD and determine the feasibility and
preliminary efficacy of this intervention in a multinational context. DESIGN:
Non-funded, pilot randomized controlled trial of intervention versus usual care.
SETTING: International, multicentre, community-based. PARTICIPANTS:
Community-living adults up to three years post stroke with moderate to severe
disability and their nominated informal caregivers. INTERVENTIONS: Intervention
patients viewed and practised rehabilitation techniques demonstrated in the DVD
over six weeks. MAIN MEASURES: Trial feasibility by number of active recruitment
sites, recruitment efficiency, randomization and follow-up. Intervention
feasibility by patient and caregiver impressions. Preliminary efficacy by the
quality of life - 5-level EuroQol-5D (EQ-5D) health status measure, General
Health Questionnaire and Centre for Epidemiological Studies-Depression at two
months. RESULTS: In total, 14 recruitment sites were established across eight
countries. Recruitment was achieved at nine (64%) sites. Over 16 months, 66
participants were recruited (mean (SD) age = 63.5 (12.47) years) and randomized
to intervention ( n = 34) and control ( n = 32) groups. In total, 54 (82%)
completed a follow-up assessment. Patient and/or caregiver comments about the
benefits and barriers to accessing the intervention were mixed. There were no
significant between-group differences in outcomes at two months ( P > 0.05).
CONCLUSION: Conducting a multinational trial of a stroke DVD requires full
funding. The intervention was acceptable to some patients and their caregivers,
yet a generalized education approach did not fully meet their needs and/or
expectations. A more individualized method may be required to meet peoples'
changing needs during stroke recovery.

Langue : ANGLAIS