The YOU CALL–WE CALL Randomized Clinical Trial

Abstract

Background-Comparison of a multimodal intervention WE CALL (study initiated phone support/information provision) versus a passive intervention YOU CALL (participant can contact a resource person) in individuals with first mild stroke. Methods and Results-This study is a single-blinded randomized clinical trial. Primary outcome includes unplanned use of health services (participant diaries) for adverse events and quality of life (Euroquol-5D, Quality of Life Index). Secondary outcomes include planned use of health services (diaries), mood (Beck Depression Inventory II), and participation (Assessment of Life Habits [LIFE-H]). Blind assessments were done at baseline, 6, and 12 months. A mixed model approach for statistical analysis on an intention-to-treat basis was used where the group factor was intervention type and occasion factor time, with a significance level of 0.01. We enrolled 186 patients (WE=92; YOU=94) with a mean age of 62.5±12.5 years, and 42.5% were women. No significant differences were seen between groups at 6 months for any outcomes with both groups improving from baseline on all measures (effect sizes ranged from 0.25 to 0.7). The only significant change for both groups from 6 months to 1 year (n=139) was in the social domains of the LIFE-H (increment in score, 0.4/9±1.3 [95% confidence interval, 0.1-0.7]; effect size, 0.3). Qualitatively, the WE CALL intervention was perceived as reassuring, increased insight, and problem solving while decreasing anxiety. Only 6 of 94 (6.4%) YOU CALL participants availed themselves of the intervention. Conclusions-Although the 2 groups improved equally over time, WE CALL intervention was perceived as helpful, whereas YOU CALL intervention was not used. Clinical Trial Registration-URL: http://www.controlled-trials.com. Unique identifier: ISRCTN95662526.(Circ Cardiovasc Qual Outcomes. 2013;6:674-679.)

Rehabilitation Interventions for Improving Social Participation After Stroke

“…Four studies required conversion of the data to mean and standard deviation; one each reported median and interquartile ranges 27 and median and range values, 33 and two reported mean and CI values 28,42 The ages of the stroke survivors ranged from 30 to 91 years. The length of the intervention ranged from 4 weeks 44 to 12 months 35,37 , with duration of 4 weeks 44 to 6 months 39,41,43 in most of the studies (22/24). Individual study details are included in Table 1 and present seven support service studies, eleven exercise studies, three mixed studies (support service and exercise) and three other studies which did not involve exercise or support service.…”

“…Studies utilizing support services included telephone calls 25,41 , home visits 35,39 , educational courses 31,34 , mailed educational information 39 and group discussions. 36 Studies utilizing support services as an intervention or in combination with other interventions 25,27,31,[33][34][35][36][37]39,41 had a frequency of at least one session per month for eight weeks.…”

“…36 Studies utilizing support services as an intervention or in combination with other interventions 25,27,31,[33][34][35][36][37]39,41 had a frequency of at least one session per month for eight weeks. Studies utilizing exercise included treadmill training 22,38,43,44 , cycling 30,33 , group exercise 37 , and progressive resistance exercise.…”

“…22,27,28 One study 41 did not have a confirmed PEdro score and it was calculated independently by two authors and disagreements were resolved by discussion. Eleven studies 23,24,26,[29][30][31]34,[42][43][44][45] did not perform an intention to treat analysis.…”

“…More than 15% of loss to follow-up occurred in four studies. 31,35,40,41 Two exercise studies recorded adverse events 38,40 , while one 28 only reported falls. One study each reported that no adverse events 25 and no serious adverse events occurred.…”