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

F@ce 2.0 - Implementation and Evaluation of a Model for a Person-centred, Information and Communication Technology and Team Based Rehabilitation Intervention for People Who Have Had Stroke in Sweden

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Mobile phone supported and team based rehabilitation; Behavioral: Rehabilitation as usual

Detailed Description

The investigators' previous feasibility study suggested beneficial effects on occupational performance and satisfaction of a mobile phone supported and person-centred rehabilitation intervention (F@ce1.0) 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susanne Guidetti, Professor; Phone Number: +46852483735 +46852483735; Email: susanne.guidetti@ki.se

Study Locations

• Sweden
  • Avesta, Sweden
    • Avesta
  • Borlänge, Sweden
    • Borlänge hemrehab
  • Falun, Sweden
    • Falun hemrehab
  • Gävle, Sweden
    • Externa stroketeamet Gävle
  • Hudiksvall, Sweden
    • Externa stroketeamet Hudiksvall
  • Mora, Sweden
    • Mora hemrehab
  • Stockholm, Sweden, 112 19
    • Neuroteam Kungsholmen, Stockholms sjukhem
  • Bromma
    • Stockholm, Bromma, Sweden, 168 62
      • Primärvårdsrehab Bromma, Stockholms Sjukhem
  • Gustavsberg
    • Stockholm, Gustavsberg, Sweden, 134 40
      • Neuroteam Värmdö Rehab
  • Handen
    • Stockholm, Handen, Sweden, 136 46
      • Aleris Rudans rehab Haninge
  • Skärholmen
    • Stockholm, Skärholmen, Sweden, 127 48
      • Aleris Rehab Skärholmen Neuroteam
  • Älvsjö
    • Stockholm, Älvsjö, Sweden, 125 44
      • Aleris Rehab Älvsjö Neuroteam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Behavioral: 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.
Active Comparator: Rehabilitation as usual; Control group participants will receive rehabilitation as usual and in addition information about stroke.	Behavioral: Rehabilitation as usual; Control group participants will receive rehabilitation as usual and in addition information about stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Impact Scale (SIS) 3.0	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'	Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Frenchay Activities Index	Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).	Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Fatigue Severity Scale-7	Questionnaire that assesses fatigue. The final score is the mean of the seven items graded between 1 (strongly disagree) and 7 (strongly agree). Scores are categorized as no fatigue (1-3) or fatigue (4-7)	Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Hospital Anxiety and Depression Scale	Questionnaire that assesses anxiety and depression comprising two subscales, each ranging from 0-21. Scores are categorised as no anxiety and depression (0-7), mild (8-10) or moderate to severe anxiety and depression (10-21)	Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Life Satisfaction Checklist	Questionnaire that assesses life satisfaction with the global item "Life as a whole" and ten domain specific items. Answering alternatives range from 1 (very dissatisfied) to 6 (very satisfied)	Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Forte
• Investigators: Principal Investigator: Susanne Guidetti, Professor, Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HELD, Karolinska Institutet

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No