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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351178
• Other study ID #: HELD, Karolinska Institutet
• Status: Completed
• Phase: N/A
• Start date: February 11, 2021
• Est. completion date: April 28, 2023

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Sweden	Avesta	Avesta
Sweden	Borlänge hemrehab	Borlänge
Sweden	Falun hemrehab	Falun
Sweden	Externa stroketeamet Gävle	Gävle
Sweden	Externa stroketeamet Hudiksvall	Hudiksvall
Sweden	Mora hemrehab	Mora
Sweden	Aleris Rehab Älvsjö Neuroteam	Stockholm	Älvsjö
Sweden	Aleris Rehab Skärholmen Neuroteam	Stockholm	Skärholmen
Sweden	Aleris Rudans rehab Haninge	Stockholm	Handen
Sweden	Neuroteam Kungsholmen, Stockholms sjukhem	Stockholm
Sweden	Neuroteam Värmdö Rehab	Stockholm	Gustavsberg
Sweden	Primärvårdsrehab Bromma, Stockholms Sjukhem	Stockholm	Bromma

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Forte

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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