TY - JOUR
T1 - Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context: a randomized controlled pilot study
AU - Jones, Kelly m
AU - Bhattacharjee, Rohit
AU - Krishnamurthi, Rita
AU - Blanton, Sarah
AU - Barker-Collo, Suzanne
AU - Theadom, Alice
AU - Thrift, Amanda g
AU - Wolf, Steven l
AU - Venketasubramanian, Narayanaswamy
AU - Parmar, Priya
AU - Maujean, Annick
AU - Ranta, Annemarei
AU - Cadilhac, Dominique
AU - Sanya, Emmanuel o
AU - Mackay-Lyons, Marilyn
AU - Pandian, Jeyaraj d
AU - Arora, Deepti
AU - Obiako, Reginald o
AU - Saposnik, Gustavo
AU - Balalla, Shivanthi
AU - Bornstein, Natan m
AU - Langhorne, Peter
AU - Norrving, Bo
AU - Brown, Nita
AU - Brainin, Michael
AU - Taylor, Denise
AU - Feigin, Valery l
N1 - Publisher Copyright:
© The Author(s) 2018.
PY - 2018/8/1
Y1 - 2018/8/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85047957752&partnerID=8YFLogxK
U2 - 10.1177/0269215518777565
DO - 10.1177/0269215518777565
M3 - Journal article
SN - 0269-2155
VL - 32
SP - 1086
EP - 1097
JO - Clinical Rehabilitation
JF - Clinical Rehabilitation
IS - 8
ER -