Nicola L Saywell1, Alain C Vandal2, Suzie Mudge1, Leigh Hale3, Paul Brown4, Valery Feigin1, Carl Hanger5, Denise Taylor1. 1. Auckland University of Technology, Auckland, New Zealand. 2. University of Auckland, Auckland, New Zealand. 3. University of Otago, Dunedin, New Zealand. 4. University of California, Merced, CA, USA. 5. Canterbury District Health Board, Christchurch, Canterbury, New Zealand.
Abstract
BACKGROUND: The number of people living with stroke has increased demand for rehabilitation. A potential solution is telerehabilitation for health care delivery to promote self-management. One such approach is the Augmented Community Telerehabilitation Intervention (ACTIV). This structured 6-month program uses limited face-to-face sessions, telephone contact, and text messages to augment stroke rehabilitation. OBJECTIVE: To investigate whether ACTIV improved physical function compared with usual care. METHODS: This 2-arm, parallel randomized controlled trial was conducted in 4 New Zealand centers. Inclusion criteria were patients with first-ever stroke, age >20 years, and discharged home. A blinded assessor completed outcome measurement in participants' homes at baseline, postintervention, and 6 months postintervention. Stratified block randomization occurred after baseline assessment, with participants allocated to ACTIV or usual care control. RESULTS:A total of 95 people were recruited (ACTIV: n = 47; control: n = 48). Postintervention intention-to-treat analysis found a nonsignificant difference between the groups in scores (4·51; P = .07) for physical function (measured by the physical subcomponent of the Stroke Impact Scale). The planned per-protocol analysis (ACTIV: n = 43; control: n = 48) found a significant difference in physical function between the groups (5·28; P = .04). Improvements in physical function were not maintained at the 12-month follow-up. CONCLUSIONS: ACTIV was not effective in improving physical function in the ACTIV group compared with the usual care group. The per-protocol analysis raises the possibility that for those who receive more than 50% of the intervention, ACTIV may be effective in preventing deterioration or even improving physical function in people with stroke, in the period immediately following discharge from hospital.
RCT Entities:
BACKGROUND: The number of people living with stroke has increased demand for rehabilitation. A potential solution is telerehabilitation for health care delivery to promote self-management. One such approach is the Augmented Community Telerehabilitation Intervention (ACTIV). This structured 6-month program uses limited face-to-face sessions, telephone contact, and text messages to augment stroke rehabilitation. OBJECTIVE: To investigate whether ACTIV improved physical function compared with usual care. METHODS: This 2-arm, parallel randomized controlled trial was conducted in 4 New Zealand centers. Inclusion criteria were patients with first-ever stroke, age >20 years, and discharged home. A blinded assessor completed outcome measurement in participants' homes at baseline, postintervention, and 6 months postintervention. Stratified block randomization occurred after baseline assessment, with participants allocated to ACTIV or usual care control. RESULTS: A total of 95 people were recruited (ACTIV: n = 47; control: n = 48). Postintervention intention-to-treat analysis found a nonsignificant difference between the groups in scores (4·51; P = .07) for physical function (measured by the physical subcomponent of the Stroke Impact Scale). The planned per-protocol analysis (ACTIV: n = 43; control: n = 48) found a significant difference in physical function between the groups (5·28; P = .04). Improvements in physical function were not maintained at the 12-month follow-up. CONCLUSIONS: ACTIV was not effective in improving physical function in the ACTIV group compared with the usual care group. The per-protocol analysis raises the possibility that for those who receive more than 50% of the intervention, ACTIV may be effective in preventing deterioration or even improving physical function in people with stroke, in the period immediately following discharge from hospital.
Authors: Lynne V Gauthier; Deborah S Nichols-Larsen; Gitendra Uswatte; Nancy Strahl; Marie Simeo; Rachel Proffitt; Kristina Kelly; Roger Crawfis; Edward Taub; David Morris; Linda Pax Lowes; Victor Mark; Alexandra Borstad Journal: EClinicalMedicine Date: 2021-12-17