NCT04337034

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

June 16, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2023

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

April 3, 2020

Last Update Submit

March 11, 2024

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • 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.

    Differences in change between baseline and 3, 6 and 12 months

Secondary Outcomes (3)

  • 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

Study Arms (2)

mobile phone supported and family-centred rehabilitation

EXPERIMENTAL

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

Behavioral: Mobile phone supported and family-centred rehabilitationProcedure: Information and blood pressure measurement

Information and blood pressure measurement

ACTIVE COMPARATOR

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

Procedure: Information and blood pressure measurement

Interventions

Mobile phone supported and family-centred rehabilitationBEHAVIORAL

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.

mobile phone supported and family-centred rehabilitation
Information and blood pressure measurementPROCEDURE

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

Information and blood pressure measurementmobile phone supported and family-centred rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mulago Hospital

Kampala, Uganda

Location

Stroke Rehabilitation Centre

Kampala, Uganda

Location

Masaka Hospital

Masaka, Uganda

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Susanne Guidetti, Professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 7, 2020

Study Start

June 16, 2022

Primary Completion

March 10, 2023

Study Completion

March 10, 2023

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

UG(3)