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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

Jones, Kelly M.; Bhattacharjee, Rohit; Krishnamurthi, Rita; Blanton, Sarah; Barker-Collo, Suzanne; Theadom, Alice; Thrift, Amanda G.; Wolf, Steven L.; Venketasubramanian, Narayanaswamy and Parmar, Priya, et al. (2018) In Clinical Rehabilitation
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,... (More)

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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@article{e206ebf2-f27d-452d-90fc-8b457c457cc5,
  abstract     = {<p>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 &gt; 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.</p>},
  author       = {Jones, Kelly M. and Bhattacharjee, Rohit and Krishnamurthi, Rita and Blanton, Sarah and Barker-Collo, Suzanne and Theadom, Alice and Thrift, Amanda G. and Wolf, Steven L. and Venketasubramanian, Narayanaswamy and Parmar, Priya and Maujean, Annick and Ranta, Annemarei and Cadilhac, Dominique and Sanya, Emmanuel O. and MacKay-Lyons, Marilyn and Pandian, Jeyaraj D. and Arora, Deepti and Obiako, Reginald O. and Saposnik, Gustavo and Balalla, Shivanthi and Bornstein, Natan M. and Langhorne, Peter and Norrving, Bo and Brown, Nita and Brainin, Michael and Taylor, Denise and Feigin, Valery L.},
  issn         = {0269-2155},
  keyword      = {caregivers,DVD,education,rehabilitation,Stroke},
  language     = {eng},
  month        = {05},
  publisher    = {SAGE Publications Inc.},
  series       = {Clinical Rehabilitation},
  title        = {Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context : a randomized controlled pilot study},
  url          = {http://dx.doi.org/10.1177/0269215518777565},
  year         = {2018},
}