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StrokeNCT04351178

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

A study testing Mobile phone supported and team based rehabilitation and Rehabilitation as usual in people with Stroke, run by Karolinska Institutet at 12 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Mobile phone supported and team based rehabilitation and Rehabilitation as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
12 sitesSweden
Study dates
11 Feb 2021to 28 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Inability to formulate activity goals
  • Inability to express themselves in Swedish

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Sweden12 sites

  • Avesta

    Avesta

  • Borlänge hemrehab

    Borlänge

  • Falun hemrehab

    Falun

  • Externa stroketeamet Gävle

    Gävle

  • Externa stroketeamet Hudiksvall

    Hudiksvall

  • Mora hemrehab

    Mora

  • Primärvårdsrehab Bromma, Stockholms Sjukhem

    Stockholm, Bromma, 168 62

  • Neuroteam Värmdö Rehab

    Stockholm, Gustavsberg, 134 40

  • Aleris Rudans rehab Haninge

    Stockholm, Handen, 136 46

  • Aleris Rehab Skärholmen Neuroteam

    Stockholm, Skärholmen, 127 48

  • Neuroteam Kungsholmen, Stockholms sjukhem

    Stockholm, 112 19

  • Aleris Rehab Älvsjö Neuroteam

    Stockholm, Älvsjö, 125 44

Other trials in Sweden

About this study

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

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.

Read the 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.

Conditions
Stroke
Being tested
Mobile phone supported and team based rehabilitation, Rehabilitation as usual
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile phone supported and team based rehabilitationBehavioural

    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 usualBehavioural

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

Study groups in NCT04351178
Study groupRoleWhat they receive
Mobile phone supported and team based rehabilitationExperimentalParticipants in the intervention group will receive an 8-week mobile phone supported and team based rehabilitation intervention (F@ce 2.0)
Receives: Behavioral: Mobile phone supported and team based rehabilitation
Rehabilitation as usualActive comparatorControl group participants will receive rehabilitation as usual and in addition information about stroke.
Receives: Behavioral: Rehabilitation as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (5)

  1. 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'

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

  2. 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).

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

  3. 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)

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

  4. 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)

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

  5. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2020
  2. Study start11 Feb 2021
  3. Primary completion28 Apr 2023
  4. Study completion28 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04351178
Sponsor's protocol ID
HELD, Karolinska Institutet
Status last verified
Mar 2024
First submitted
15 Apr 2020
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Soderhielm K, Hawkins J, Ytterberg C, Tistad M, Guidetti S. Process evaluation of F@ce 2.0, a team-based, person-centred intervention for rehabilitation after stroke supported by ICT. BMC Health Serv Res. 2026 May 7;26(1):663. doi: 10.1186/s12913-026-14628-6.

    PubMed 42092907

  • Soderhielm K, Tistad M, Ytterberg C, Guidetti S. Experiences of F@ce 2.0: a person-centred intervention for home-based rehabilitation after stroke supported by digital technology - a qualitative study. BMJ Open. 2025 Jul 16;15(7):e089147. doi: 10.1136/bmjopen-2024-089147.

    PubMed 40669890

  • 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.

    PubMed 35926996

Questions about this trial

What is this clinical trial studying?

A study testing Mobile phone supported and team based rehabilitation and Rehabilitation as usual in people with Stroke, run by Karolinska Institutet at 12 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-efficacy Scale (time frame: Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04351178, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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