F@ce 2.0 a Mobile Phone-supported and Family-centred Rehabilitation Intervention After Stroke in Uganda

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: Mobile phone supported and family-centred rehabilitation; Procedure: Information and blood pressure measurement

• Registration Number: NCT04337034
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-07
• Study Start: 2022-06-16
• Primary Completion: 2023-03-10
• Study Completion: 2023-03-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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.

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Exclusion Criteria

• none

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mobile phone supported and family-centred rehabilitation	Mobile phone supported and family-centred rehabilitation	Participants in the intervention group will receive an 8-week mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0)
mobile phone supported and family-centred rehabilitation	Information and blood pressure measurement	Participants in the intervention group will receive an 8-week mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0)
Information and blood pressure measurement	Information and blood pressure measurement	Control group participants will be given information about stroke and their blood pressure will be measured

Primary Outcome Measures

Name	Time	Method
Self-efficacy Scale	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 Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure (COPM)	Differences in change between baseline and 3, 6 and 12 months	COPM measures performance and satisfaction in self-care, productivity and leisure from the individual's perspective using a scale of 1-10. The participant is asked 1) to rate performance of the specified activities using a 1 to 10 scale and 2) to score his or her satisfaction with that performance using the same scale. Weighted scores of the chosen activities are added separately for performance and satisfaction to create two summative scores. The summative scores are then divided by the number of rated activities to provide COPM scores.
Stroke Impact Scale (SIS) 3.0 Uganda version	Differences in change between baseline and 3, 6 and 12 months	Assesses the perceived impact on functioning in everyday life in eight domains: Strength, Memory and thinking, Emotions, Communication, ADL/ Instrumental activities of daily living (IADL), Mobility, Hand function and Participation. The SIS includes 59 items within these eight domains. Aggregated scores ranges from 0 to 100, the higher the score, the lower the perceived impact of stroke, i.e. fewer problems in everyday life. The SIS 3.0 also includes a question to assess the participant's global perception of recovery presented in a vertical analogue scale ranging from '0 = no recovery to 100 = full recovery'.
Barthel Index	Differences in change between baseline and 3, 6 and 12 months	Measures independence in 10 self-care and mobility activities. Scores range from 0 to 100, with a lower score indicating greater dependency.

Trial Locations

Locations (3)

Stroke Rehabilitation Centre; 🇺🇬 Kampala, Uganda

Mulago Hospital; 🇺🇬 Kampala, Uganda

Masaka Hospital; 🇺🇬 Masaka, Uganda