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- Title
Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context: a randomized controlled pilot study.
- Authors
Jones, Kelly M.; Bhattacharjee, Rohit; Krishnamurthi, Rita; Blanton, Sarah; Barker-Collo, Suzanne; Theadom, Alice; Thrift, Amanda G.; Wolf, Steven L.; Venketasubramanian, Narayanaswamy; Parmar, Priya; Maujean, Annick; Ranta, Annemarei; Cadilhac, Dominique; Sanya, Emmanuel O.; MacKay-Lyons, Marilyn; Pandian, Jeyaraj D.; Arora, Deepti; Obiako, Reginald O.; Saposnik, Gustavo; Balalla, Shivanthi
- Abstract
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.
- Subjects
QUALITY of life; CAREGIVERS; CHI-squared test; CLINICAL trials; MEDICAL cooperation; PATIENT education; PROBABILITY theory; PSYCHOLOGICAL tests; QUESTIONNAIRES; RESEARCH; RESEARCH funding; STATISTICAL sampling; STATISTICAL hypothesis testing; DVD-Video discs; PILOT projects; RANDOMIZED controlled trials; BURDEN of care; TREATMENT effectiveness; PRE-tests &; post-tests; INDEPENDENT living; DATA analysis software; PATIENTS' attitudes; STROKE rehabilitation; DESCRIPTIVE statistics
- Publication
Clinical Rehabilitation, 2018, Vol 32, Issue 8, p1086
- ISSN
0269-2155
- Publication type
Article
- DOI
10.1177/0269215518777565