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

NCT ID: NCT04337034

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-16

Study Completion Date

2023-03-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 ([email protected]) 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

Mobile phone supported and family-centred rehabilitation

Intervention Type BEHAVIORAL

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.

Information and blood pressure measurement

Intervention Type PROCEDURE

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

Information and blood pressure measurement

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

Group Type ACTIVE_COMPARATOR

Information and blood pressure measurement

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mobile phone supported and family-centred rehabilitation

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 BEHAVIORAL

Information and blood pressure measurement

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Susanne Guidetti

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susanne Guidetti, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mulago Hospital

Kampala, , Uganda

Site Status

Stroke Rehabilitation Centre

Kampala, , Uganda

Site Status

Masaka Hospital

Masaka, , Uganda

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Uganda

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

F@ce 2.0

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.