Clinical trial NCT04337034: F@ce 2.0 a Mobile Phone-supported and Family-centred Rehabilitation Intervention After Stroke in Uganda
Official title: Participation in Everyday Life - A Randomized Controlled Trial of Mobile Phone-supported and Family-centred Rehabilitation After Stroke in Uganda.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2020-04-07
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to participate in F@ce 2.0 (IG) or a control group (CG) receiving usual rehabilitation at two different sites; both an urban (IG+CG) and rural site (CG+IG) in Uganda
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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:

* none

Primary outcomes:
measure: Self-efficacy Scale
timeFrame: Differences in change between baseline and 3, 6 and 12 months
Secondary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Differences in change between baseline and 3, 6 and 12 months
measure: Stroke Impact Scale (SIS) 3.0 Uganda version
timeFrame: Differences in change between baseline and 3, 6 and 12 months
measure: Barthel Index
timeFrame: Differences in change between baseline and 3, 6 and 12 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Hospital
city: Kampala
country: Uganda
facility: Stroke Rehabilitation Centre
city: Masaka
country: Uganda
facility: Masaka Hospital
Study officials:
affiliation: Karolinska Institutet
name: Susanne Guidetti, Professor
role: PRINCIPAL_INVESTIGATOR
References: