A randomized controlled trial of mobile phone-supported and family-centred rehabilitation after stroke in Uganda, F@ce 2.0: a study protocol (Preprint)

Abstract

Stroke is a global societal challenge. Thirteen million people annually suffer a stroke, and the prevalence of stroke is increasing in low-income countries and accessible rehabilitation needs to be developed. Information and Communication Technology can give access to rehabilitation support through information, self-evaluation, and self-management of rehabilitation. The F@ce 2.0 rehabilitation program entails support in goal-setting and problem-solving strategies through daily SMS reminders over eight weeks to improve performance of valued activities in everyday life. Our hypothesis is that F@ce 2.0 will increase functioning in daily activities, participation in everyday life, and improve the performance and satisfaction of valued daily activities and self-efficacy, i.e., confidence in own ability to perform activities, among people living with consequences of stroke.

The purpose of the study is to implement and evaluate the effects of F@ce 2.0, a family-centred and mobile phone-supported rehabilitation program, on performance in daily activities and participation in everyday life in comparison to ordinary rehabilitation among persons who have had a stroke, and their family members, in Uganda. An additional aim is to explore experiences of participating in F@ce 2.0 and plausible mechanisms of impact that might explain the potential effects of using F@ce 2.0.

A randomised controlled trial will be conducted to compare outcomes of F@ce 2.0 and a control group receiving ordinary rehabilitation. Health professionals will recruit 90 clients in urban and rural areas. Primary outcomes for clients: perceived performance in daily activities assessed by the Canadian Occupational Performance Measure and self-efficacy assessed by the Self-Efficacy Scale; for family members: caregiver burden collected by the Caregiver Burden Scale. Qualitative interviews will be used to explore experiences of people with stroke and family members of participating in F@ce 2.0, and a process evaluation will be conducted using mixed methods in a single-case study design to explore the implementation process.

This study will provide evidence of plausible effects of F@ce 2.0 and the process of implementing the program in low-income countries.

Plausible effects of F@ce 2.0, experiences of participating in the intervention and information on the process of implementing the program in low-income countries will be provided.

Trial Registration number: ClinicalTrials.gov Identifier: NCT 04337034 04/06/2020