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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Mobile phone supported and family-centred rehabilitation
Information and blood pressure measurement
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mulago HospitalRecruiting
  • Stroke Rehabilitation CentreRecruiting
  • Masaka HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mobile phone supported and family-centred rehabilitation

Information and blood pressure measurement

Arm Description

Participants in the intervention group will receive an 8-week mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0)

Control group participants will be given information about stroke and their blood pressure will be measured

Outcomes

Primary Outcome Measures

Self-efficacy Scale
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

Canadian Occupational Performance Measure (COPM)
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
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
Measures independence in 10 self-care and mobility activities. Scores range from 0 to 100, with a lower score indicating greater dependency.

Full Information

First Posted
April 3, 2020
Last Updated
June 27, 2022
Sponsor
Karolinska Institutet
Collaborators
The Swedish Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT04337034
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
The Swedish Research Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mobile phone supported and family-centred rehabilitation
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive an 8-week mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0)
Arm Title
Information and blood pressure measurement
Arm Type
Active Comparator
Arm Description
Control group participants will be given information about stroke and their blood pressure will be measured
Intervention Type
Behavioral
Intervention Name(s)
Mobile phone supported and family-centred rehabilitation
Intervention Description
Participants in the intervention group will receive an eight-week mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0).The participants will be introduced to a problem-solving strategy intended to facilitate the learning and problem-solving process to be used during the intervention. The strategy will provide a structure for healthcare professionals delivering the intervention. Three targets (goals) in daily activities will be formulated that the person wants and needs to do within the home environment. Each activity will be practiced together with the healthcare professionals and family members. Family members will be informed about the participant's target activities and the planned strategies for reaching the targets. The participants will practice the target activities in their home environment supported by mobile phone calls and SMS. In addition they will be given information about stroke and their blood pressure will be measured.
Intervention Type
Procedure
Intervention Name(s)
Information and blood pressure measurement
Intervention Description
Control group participants will be given information about stroke and their blood pressure will be measured.
Primary Outcome Measure Information:
Title
Self-efficacy Scale
Description
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.
Time Frame
Differences in change between baseline and 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
Differences in change between baseline and 3, 6 and 12 months
Title
Stroke Impact Scale (SIS) 3.0 Uganda version
Description
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'.
Time Frame
Differences in change between baseline and 3, 6 and 12 months
Title
Barthel Index
Description
Measures independence in 10 self-care and mobility activities. Scores range from 0 to 100, with a lower score indicating greater dependency.
Time Frame
Differences in change between baseline and 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne Guidetti, Professor
Phone
+46852483735
Email
susanne.guidetti@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Guidetti, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mulago Hospital
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Name
Stroke Rehabilitation Centre
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Name
Masaka Hospital
City
Masaka
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cedrak Ategeka
Email
cedrak.ategeka@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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