Evaluating Rehabkompassen® - A Digital Graphic Follow-up Tool for Identifying Rehabilitation Needs Among People With Stroke: A Randomized Clinical Feasibility Study (Preprint)
Authors: Hu Xiaolei , Jonzén Karolina , Lindahl Olof A. , Karlsson Marcus , Norström Fredrik , Lundström Erik , Sunnerhagen Katharina Stibrant 
Published: May 2022

BACKGROUND

Stroke is a leading cause of disability among adults, with heavy social and economic burden worldwide. A cost-effective solution is urgently needed to facilitate identification of individual rehabilitation needs and thereby provide tailored rehabilitations to reduce disability among people with stroke. A novel digital follow-up tool Rehabkompassen® has recently been developed to facilitate capturing the multidimensional rehabilitation needs of people with stroke.

OBJECTIVE

To evaluate feasibility and acceptability of conducting a definitive trial to evaluate Rehabkompassen® as a digital follow-up tool among people with stroke in outpatient clinical settings.

METHODS

This pilot study of Rehabkompassen® is a parallel, open-label, 2-arm prospective, proof-of-concept randomized controlled trial (RCT) with allocation ratio 1:1 in a single outpatient clinic. Those who had suffered a stroke within 3 the previous months, aged >18 years, and living in the community, were included. The trial compared usual outpatient visits with Rehabkompassen® (intervention group) and without (control group) at 3-month follow-up as well as usual outpatient visit with Rehabkompassen® at 12-month follow-up. The information on recruitment rate, delivery, and uptake of the Rehabkompassen®, assessment and outcome measures completion rates, and frequency of withdrawals and loss of follow-up as well as satisfaction scores were obtained. The key outcomes were evaluated in both groups.

RESULTS

Twenty-eight participants (14 control, 14 Rehabkompassen®) participated in the current study, with 100 patients screened. The overall recruitment rate was 28%. Retention in the trial was 86% at 12-month follow-up, indicating high adherence to study protocol. Meanwhile, all participants used the tool as planned during their follow-ups, which provided 100% task-completion rate of using Rehabkompassen® and suggested high feasibility. Both patient- and physician-participants reported high satisfaction with the instrument, indicating high acceptability of the Rehabkompassen®. Two physicians (100%) and 18 patients (75%) were willing to use the tool in the future. Furthermore, both modified Rankin Scale (mRS) as the primary outcome and various stroke impacts as secondary outcomes were successfully collected and compared in this study.

CONCLUSIONS

This study demonstrated high feasibility and adherence of the study protocol as well as high acceptability of the Rehabkompassen® among patients with stroke and physicians in an outpatient setting. The information collected in this feasibility study combined with the amendments of the study protocol may improve the future definitive RCT. The results of this trial support the feasibility and acceptability of conducting a large definitive RCT.

CLINICALTRIAL

ClinicalTrials.gov Identifier: NCT04915027