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Clinical Trials/NCT04351178
NCT04351178
Completed
Not Applicable

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

Karolinska Institutet12 sites in 1 country100 target enrollmentFebruary 11, 2021
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Karolinska Institutet
Enrollment
100
Locations
12
Primary Endpoint
Self-efficacy Scale
Status
Completed
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
February 11, 2021
End Date
April 28, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susanne Guidetti

Professor

Karolinska Institutet

Eligibility Criteria

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

Outcomes

Primary Outcomes

Self-efficacy Scale

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

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

Canadian Occupational Performance Measure (COPM)

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

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.

Caregiver Burden Scale

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

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.

Secondary Outcomes

  • Life Satisfaction Checklist(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)
  • Stroke Impact Scale (SIS) 3.0(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)

Study Sites (12)

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