Implementing and Evaluating a Mobile Phone-Supported and Family-Centered Rehabilitation Program for People With Stroke in Uganda (F@ce 2.0): Protocol for a Randomized Controlled Trial.

Background: Stroke is a global societal challenge. Annually, 13 million people experience stroke, and the prevalence of stroke is increasing in low-income countries; hence, accessible rehabilitation needs to be developed. Information and communication technology can help by providing access to rehabilitation support through information, self-evaluation, and self-management of rehabilitation. The F@ce 2.0 rehabilitation program provides support in goal-setting and problem-solving strategies through phone calls from the interventionist twice a week and daily SMS text message reminders over 8 weeks to improve performance in valued activities in everyday life. Our hypothesis is that F@ce 2.0 will increase functioning in daily activities and participation in everyday life as well as improve performance and satisfaction in valued daily activities and self-efficacy (ie, confidence in own ability to perform activities) among people living with the consequences of stroke.

Objective: This study aims to implement F@ce 2.0, a mobile phone-supported and family-centered rehabilitation program, and evaluate its effects on performance in daily activities and participation in everyday life in comparison to ordinary rehabilitation among persons with 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 F@ce 2.0.

Methods: A randomized controlled trial will be conducted to compare the outcomes of the F@ce 2.0 group and a control group receiving ordinary rehabilitation. Health care professionals will recruit 90 clients from both urban and rural areas. The primary outcomes for persons with stroke are perceived performance in daily activities assessed using the Canadian Occupational Performance Measure and self-efficacy assessed using the Self-Efficacy Scale; for family members, the primary outcome is caregiver burden evaluated using the Caregiver Burden Scale. Descriptive statistics will be used to present characteristics and outcomes at 3 and 6 months. All statistical analyses comparing the outcomes at the different time points between the F@ce 2.0 and control groups will be performed using intention-to-treat analysis. Qualitative interviews will be used to explore the experiences of persons with stroke and their family members participating in F@ce 2.0, using a grounded theory approach to data collection and analysis. A process evaluation will be conducted using a single-case study design with mixed methods to explore the implementation process.

Results: Recruitment and data collection in the randomized controlled trial were initiated in January 2022 and have been completed. The intervention has been provided to 51 participants in the intervention group. Interviews of persons with stroke, family members, and health care professionals have been conducted. Data analysis will be performed during autumn 2024 and spring 2025.

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

International Registered Report Identifier (irrid): DERR1-10.2196/60955.