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Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context: a randomized controlled pilot study [with consumer summary] |
Jones KM, Bhattacharjee R, Krishnamurthi R, Blanton S, Barker-Collo S, Theadom A, Thrift AG, Wolf SL, Venketasubramanian N, Parmar P, Maujean A, Ranta A, Cadilhac D, Sanya EO, MacKay-Lyons M, Pandian JD, Arora D, Obiako RO, Saposnik G, Balalla S, Bornstein NM, Langhorne P, Norrving B, Brown N, Brainin M, Taylor D, Feigin VL |
Clinical Rehabilitation 2018 Aug;32(8):1086-1097 |
clinical trial |
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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 16months, 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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