F@ce 2.0 - Information and Communication Technology-based Rehabilitation Intervention After Stroke in Sweden
- Conditions
- Stroke
- Interventions
- Behavioral: Mobile phone supported and team based rehabilitationBehavioral: Rehabilitation as usual
- Registration Number
- NCT04351178
- Lead Sponsor
- Karolinska Institutet
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- Inability to formulate activity goals
- Inability to express themselves in Swedish
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mobile phone supported and team based rehabilitation 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) Rehabilitation as usual Rehabilitation as usual Control group participants will receive rehabilitation as usual and in addition information about stroke.
- Primary Outcome Measures
Name Time Method Self-efficacy Scale 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) 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 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 Outcome Measures
Name Time Method Life Satisfaction Checklist Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment 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)
Frenchay Activities Index Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment 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).
Stroke Impact Scale (SIS) 3.0 Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment 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'
Fatigue Severity Scale-7 Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment 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)
Hospital Anxiety and Depression Scale Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment 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)
Trial Locations
- Locations (12)
Primärvårdsrehab Bromma, Stockholms Sjukhem
🇸🇪Stockholm, Bromma, Sweden
Borlänge hemrehab
🇸🇪Borlänge, Sweden
Falun hemrehab
🇸🇪Falun, Sweden
Externa stroketeamet Hudiksvall
🇸🇪Hudiksvall, Sweden
Aleris Rehab Skärholmen Neuroteam
🇸🇪Stockholm, Skärholmen, Sweden
Mora hemrehab
🇸🇪Mora, Sweden
Aleris Rudans rehab Haninge
🇸🇪Stockholm, Handen, Sweden
Avesta
🇸🇪Avesta, Sweden
Neuroteam Värmdö Rehab
🇸🇪Stockholm, Gustavsberg, Sweden
Externa stroketeamet Gävle
🇸🇪Gävle, Sweden
Neuroteam Kungsholmen, Stockholms sjukhem
🇸🇪Stockholm, Sweden
Aleris Rehab Älvsjö Neuroteam
🇸🇪Stockholm, Älvsjö, Sweden