Clinical trial NCT04351178: F@ce 2.0 - Information and Communication Technology-based Rehabilitation Intervention After Stroke in Sweden
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Forte
First posted: 2020-04-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Self-efficacy Scale
timeFrame: Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
measure: Caregiver Burden Scale
timeFrame: Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Secondary outcomes:
measure: Stroke Impact Scale (SIS) 3.0
timeFrame: Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
measure: Frenchay Activities Index
timeFrame: Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
measure: Fatigue Severity Scale-7
timeFrame: Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
measure: Hospital Anxiety and Depression Scale
timeFrame: Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
measure: Life Satisfaction Checklist
timeFrame: Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Primärvårdsrehab Bromma, Stockholms Sjukhem
state: Bromma
city: Stockholm
country: Sweden
facility: Neuroteam Värmdö Rehab
state: Gustavsberg
city: Stockholm
country: Sweden
facility: Aleris Rudans rehab Haninge
state: Handen
city: Stockholm
country: Sweden
facility: Aleris Rehab Skärholmen Neuroteam
state: Skärholmen
city: Avesta
country: Sweden
facility: Avesta
city: Borlänge
country: Sweden
facility: Borlänge hemrehab
city: Falun
country: Sweden
facility: Falun hemrehab
city: Gävle
country: Sweden
facility: Externa stroketeamet Gävle
city: Hudiksvall
country: Sweden
facility: Externa stroketeamet Hudiksvall
city: Mora
country: Sweden
facility: Mora hemrehab
city: Stockholm
country: Sweden
facility: Neuroteam Kungsholmen, Stockholms sjukhem
city: Stockholm
country: Sweden
facility: Aleris Rehab Älvsjö Neuroteam
state: Älvsjö
Study officials:
affiliation: Karolinska Institutet
name: Susanne Guidetti, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.