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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Mobile phone supported and team based rehabilitation
Rehabilitation as usual
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Primärvårdsrehab Bromma, Stockholms SjukhemRecruiting
  • Neuroteam Värmdö RehabRecruiting
  • Aleris Rudans rehab HaningeRecruiting
  • Aleris Rehab Skärholmen NeuroteamRecruiting
  • AvestaRecruiting
  • Borlänge hemrehabRecruiting
  • Falun hemrehabRecruiting
  • Externa stroketeamet GävleRecruiting
  • Externa stroketeamet HudiksvallRecruiting
  • Mora hemrehabRecruiting
  • Neuroteam Kungsholmen, Stockholms sjukhemRecruiting
  • Aleris Rehab Älvsjö NeuroteamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile phone supported and team based rehabilitation

Rehabilitation as usual

Arm Description

Participants in the intervention group will receive an 8-week mobile phone supported and team based rehabilitation intervention (F@ce 2.0)

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

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

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'
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).
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)
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)
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)

Full Information

First Posted
April 15, 2020
Last Updated
June 27, 2022
Sponsor
Karolinska Institutet
Collaborators
Forte
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1. Study Identification

Unique Protocol Identification Number
NCT04351178
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Forte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobile phone supported and team based rehabilitation
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive an 8-week mobile phone supported and team based rehabilitation intervention (F@ce 2.0)
Arm Title
Rehabilitation as usual
Arm Type
Active Comparator
Arm Description
Control group participants will receive rehabilitation as usual and in addition information about stroke.
Intervention Type
Behavioral
Intervention Name(s)
Mobile phone supported and team based rehabilitation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation as usual
Intervention Description
Control group participants will receive rehabilitation as usual and in addition information about stroke.
Primary Outcome Measure Information:
Title
Self-efficacy Scale
Description
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
Time Frame
Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Title
Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Title
Caregiver Burden Scale
Description
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.
Time Frame
Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Secondary Outcome Measure Information:
Title
Stroke Impact Scale (SIS) 3.0
Description
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'
Time Frame
Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Title
Frenchay Activities Index
Description
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).
Time Frame
Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Title
Fatigue Severity Scale-7
Description
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)
Time Frame
Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Title
Hospital Anxiety and Depression Scale
Description
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)
Time Frame
Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Title
Life Satisfaction Checklist
Description
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)
Time Frame
Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne Guidetti, Professor
Phone
+46852483735
Ext
+46852483735
Email
susanne.guidetti@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Guidetti, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primärvårdsrehab Bromma, Stockholms Sjukhem
City
Stockholm
State/Province
Bromma
ZIP/Postal Code
168 62
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahabad MohammedPour
Phone
+46724533980
Email
Mahabad.MohammedPour@stockholmssjukhem.se
Facility Name
Neuroteam Värmdö Rehab
City
Stockholm
State/Province
Gustavsberg
ZIP/Postal Code
134 40
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Lord
Phone
+47722444727
Email
anna.lord-zakrisson@regionstockholm.se
Facility Name
Aleris Rudans rehab Haninge
City
Stockholm
State/Province
Handen
ZIP/Postal Code
136 46
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna-Lena Larsson
Phone
+4686064181
Email
anna-lena.larsson@aleris.se
Facility Name
Aleris Rehab Skärholmen Neuroteam
City
Stockholm
State/Province
Skärholmen
ZIP/Postal Code
127 48
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgitta Noréus
Phone
+46840915113
Email
birgitta.noreus@aleris.se
Facility Name
Avesta
City
Avesta
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Kvarnström Sonnback
Phone
+46721433599
Email
Helena.KvarnstromSonnback@regiondalarna.se
Facility Name
Borlänge hemrehab
City
Borlänge
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Fosselius
Phone
+46243497349
Email
caroline.fosselius@regiondalarna.se
Facility Name
Falun hemrehab
City
Falun
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anette Bylund
Phone
+4623491417
Email
anette.bylund@regiondalarna.se
Facility Name
Externa stroketeamet Gävle
City
Gävle
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Pettersson
Phone
+4626150190
Email
erika.pettersson@regiongavleborg.se
Facility Name
Externa stroketeamet Hudiksvall
City
Hudiksvall
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Stillmark
Phone
+46705792840
Email
helen.stillmark@regiongavleborg.se
Facility Name
Mora hemrehab
City
Mora
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Pakkanen
Phone
+46720849137
Email
anna.pakkanen@regiondalarna.se
Facility Name
Neuroteam Kungsholmen, Stockholms sjukhem
City
Stockholm
ZIP/Postal Code
112 19
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Bergström
Phone
+46737454437
Email
caroline.bergstrom@stockholmssjukhem.se
Facility Name
Aleris Rehab Älvsjö Neuroteam
City
Stockholm
State/Province
Älvsjö
ZIP/Postal Code
125 44
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katja Kallio
Phone
+46840915198
Email
katja.kallio@aleris.se

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35926996
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.
Results Reference
derived

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

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