Participation in Everyday Life - A Randomized Controlled Trial of Mobile Phone-supported and Family-centred Rehabilitation After Stroke in Uganda.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 98
- Locations
- 3
- Primary Endpoint
- Self-efficacy Scale
Study Overview
Brief Summary
The purpose of the present proposal is to implement and evaluate a new model for mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0) with regard to functioning in activities in daily living and participation in everyday life among persons with stroke and their families (in rural and urban areas) in Uganda.
Detailed Description
The investigators' previous feasibility study suggested beneficial effects on self-efficacy and occupational performance and satisfaction of a mobile phone supported and family-centred rehabilitation intervention (F@ce1.0) after stroke in Uganda. The purpose of the present proposal is to implement and evaluate F@ce on functioning in activities in daily living (ADL) and participation in everyday life among persons with stroke and their families.
With recommendations on evaluation of complex interventions both outcomes and processes will be studied and hence both quantitative and qualitative methods will be applied. In a randomized controlled trial F@ce 2.0 will be evaluated compared to ordinary rehabilitation in urban/rural Uganda regarding; self-efficacy, perceived performance and participation in everyday activities, independence in ADL, health care utilization and the families´ perceived participation in everyday activities. Qualitative data will explore experiences of people with stroke and family members of participating in F@ce 2.0. This research program has a multidisciplinary perspective for sustainable rehabilitation, a prerequisite for better living conditions for people with stroke in low/middle income countries.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •stroke diagnosis identified with CT scan or clinical symptoms
- •inhabitant in a rural part of Kalungu District, near Masaka Uganda, or Kampala with surroundings
- •access to and ability to use a mobile phone
- •ability to speak and express themselves in English and/or Luganda
- •Modified Rankin Scale level 2 to 4.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Self-efficacy Scale
Time Frame: Differences in change between baseline and 3, 6 and 12 months
Participants are instructed to rate how confident they feel about performing each of 16 everyday activities on a 10-point rating scale ranging from 1) "not confident at all in my ability" to 10) "very confident in my ability". The average of all responses are calculated.
Secondary Outcomes
- Canadian Occupational Performance Measure (COPM)(Differences in change between baseline and 3, 6 and 12 months)
- Stroke Impact Scale (SIS) 3.0 Uganda version(Differences in change between baseline and 3, 6 and 12 months)
- Barthel Index(Differences in change between baseline and 3, 6 and 12 months)
Investigators
Susanne Guidetti
Professor
Karolinska Institutet