Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context: a randomized controlled pilot study
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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
Bornstein, Natan M
Langhorne, Peter
Norrving, Bo
Brown, Nita
Brainin, Michael
Taylor, Denise
Feigin, Valery L
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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.
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Clinical Rehabilitation
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32
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8
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MAUJEAN, Francoise, Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context: a randomized controlled pilot study, Clinical Rehabilitation, Vol 32, Issue 8, 2018. Copyright 2018 The Authors. Reprinted by permission of SAGE Publications.
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Biomedical and clinical sciences