F@ce 2.0 - Information and Communication Technology-based Rehabilitation Intervention After Stroke in Sweden

NCT ID: NCT04351178

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-11

Study Completion Date

2023-04-28

Brief Summary

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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 Sweden.

Detailed Description

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The investigators' previous feasibility study suggested beneficial effects on occupational performance and satisfaction of a mobile phone supported and person-centred rehabilitation intervention ([email protected]) after stroke in Stockholm, Sweden. The purpose of the present proposal is to implement and evaluate F@ce 2.0 on functioning in activities in daily living (ADL) and participation in everyday life among persons with stroke and their significant others (someone identified by the person with stroke as close i.e.partner, friend, son, daughter).

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 Sweden 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, significant others and rehabilitation staff of participating in F@ce 2.0. The research project has a multidisciplinary perspective for sustainable rehabilitation interventions, a prerequisite for better participation in everyday life for people with stroke.

Conditions

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Stroke

Study Design

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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 Sweden
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mobile phone supported and team based rehabilitation

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

Group Type EXPERIMENTAL

Mobile phone supported and team based rehabilitation

Intervention Type BEHAVIORAL

Participants in the intervention group will receive an 8-week mobile phone supported and team based 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 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 significant others. The significant others will be informed about the participant's goals and the planned strategies for reaching the goals. The participants will practice the activities in their home environment supported by mobile phone calls and text messages. In addition they will be given information about stroke.

Rehabilitation as usual

Control group participants will receive rehabilitation as usual and in addition information about stroke.

Group Type ACTIVE_COMPARATOR

Rehabilitation as usual

Intervention Type BEHAVIORAL

Control group participants will receive rehabilitation as usual and in addition information about stroke.

Interventions

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Mobile phone supported and team based rehabilitation

Participants in the intervention group will receive an 8-week mobile phone supported and team based 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 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 significant others. The significant others will be informed about the participant's goals and the planned strategies for reaching the goals. The participants will practice the activities in their home environment supported by mobile phone calls and text messages. In addition they will be given information about stroke.

Intervention Type BEHAVIORAL

Rehabilitation as usual

Control group participants will receive rehabilitation as usual and in addition information about stroke.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Persons who have had a stroke
* Enrolled in one of the participating home rehabilitation teams in Stockholm and Dalarna
* Able to participate in eight weeks of intervention

Exclusion Criteria

* Inability to formulate activity goals
* Inability to express themselves in Swedish
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forte

INDUSTRY

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Susanne Guidetti

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susanne Guidetti, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Primärvårdsrehab Bromma, Stockholms Sjukhem

Stockholm, Bromma, Sweden

Site Status

Neuroteam Värmdö Rehab

Stockholm, Gustavsberg, Sweden

Site Status

Aleris Rudans rehab Haninge

Stockholm, Handen, Sweden

Site Status

Aleris Rehab Skärholmen Neuroteam

Stockholm, Skärholmen, Sweden

Site Status

Avesta

Avesta, , Sweden

Site Status

Borlänge hemrehab

Borlänge, , Sweden

Site Status

Falun hemrehab

Falun, , Sweden

Site Status

Externa stroketeamet Gävle

Gävle, , Sweden

Site Status

Externa stroketeamet Hudiksvall

Hudiksvall, , Sweden

Site Status

Mora hemrehab

Mora, , Sweden

Site Status

Neuroteam Kungsholmen, Stockholms sjukhem

Stockholm, , Sweden

Site Status

Aleris Rehab Älvsjö Neuroteam

Stockholm, Älvsjö, Sweden

Site Status

Countries

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Sweden

References

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Soderhielm K, Tistad M, Ytterberg C, Guidetti S. Experiences of F@ce 2.0: a person-centred intervention for home-based rehabilitation after stroke supported by digital technology - a qualitative study. BMJ Open. 2025 Jul 16;15(7):e089147. doi: 10.1136/bmjopen-2024-089147.

Reference Type DERIVED
PMID: 40669890 (View on PubMed)

Eriksson G, Tistad M, Elf M, Fors U, von Koch L, Ytterberg C, Guidetti S. Study protocol of a non-randomised controlled trial evaluating the effectiveness of the F@ce 2.0 programme: a person-centred, ICT-supported and interdisciplinary rehabilitation intervention after stroke. BMJ Open. 2022 Aug 4;12(8):e058748. doi: 10.1136/bmjopen-2021-058748.

Reference Type DERIVED
PMID: 35926996 (View on PubMed)

Other Identifiers

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HELD, Karolinska Institutet

Identifier Type: -

Identifier Source: org_study_id

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