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

NCT04351178 | Completed DMC

• 1 other identifier: HELD, Karolinska Institutet
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 12

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 Sweden.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• 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

  Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment

• Canadian Occupational Performance Measure (COPM)

  Canadian Occupational Performance Measure (COPM) measures performance and satisfaction in self-care, productivity and leisure from the individual's perspective. The participant is asked 1) to rate performance of the specified activities using a 1 (low) to 10 (high) 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.

  Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment

• Caregiver Burden Scale

  Questionnaire that consists of 22 items for different types of subjective caregiver burden, covering areas of the caregiver's health, feelings of psychological well-being, relations, social network, physical workload, and environmental aspects. The items are scored on a scale from 1 to 4 and the higher the score the greater the burden.

  Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment

Secondary Outcomes (5)

• Stroke Impact Scale (SIS) 3.0

  Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment

• Frenchay Activities Index

  Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment

• Fatigue Severity Scale-7

  Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment

• Hospital Anxiety and Depression Scale

  Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment

• Life Satisfaction Checklist

  Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment

Study Arms (2)

Mobile phone supported and team based rehabilitation

EXPERIMENTAL

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

Behavioral: Mobile phone supported and team based rehabilitation

Rehabilitation as usual

ACTIVE COMPARATOR

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

Behavioral: Rehabilitation as usual

Interventions

Mobile phone supported and team based rehabilitation 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.

Mobile phone supported and team based rehabilitation

Rehabilitation as usual BEHAVIORAL

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

Rehabilitation as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to formulate activity goals
• Inability to express themselves in Swedish

Sponsors & Collaborators

• Karolinska Institutet: lead
• Forte: collaborator

Study Sites (12)

Primärvårdsrehab Bromma, Stockholms Sjukhem

Stockholm, Bromma, 168 62, Sweden

Location

Neuroteam Värmdö Rehab

Stockholm, Gustavsberg, 134 40, Sweden

Location

Aleris Rudans rehab Haninge

Stockholm, Handen, 136 46, Sweden

Location

Aleris Rehab Skärholmen Neuroteam

Stockholm, Skärholmen, 127 48, Sweden

Location

Avesta

Avesta, Sweden

Location

Borlänge hemrehab

Borlänge, Sweden

Location

Falun hemrehab

Falun, Sweden

Location

Externa stroketeamet Gävle

Gävle, Sweden

Location

Externa stroketeamet Hudiksvall

Hudiksvall, Sweden

Location

Mora hemrehab

Mora, Sweden

Location

Neuroteam Kungsholmen, Stockholms sjukhem

Stockholm, 112 19, Sweden

Location

Aleris Rehab Älvsjö Neuroteam

Stockholm, Älvsjö, 125 44, Sweden

Location

Related Publications (2)

• 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.

  PMID: 40669890 DERIVED

• 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.

  PMID: 35926996 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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 Sweden

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 17, 2020
• Study Start: February 11, 2021
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (12)