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NCT Number: NCT04351178

F@ce 2.0 - Information and Communication Technology-based Rehabilitation Intervention After 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primärvårdsrehab Bromma, Stockholms Sjukhem, Stockholm, Bromma, Sweden

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About this study

The investigators' previous feasibility study suggested beneficial effects on occupational performance and satisfaction of a mobile phone supported and person-centred rehabilitation intervention ([email protected]) 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile phone supported and team based rehabilitation

Behavioral

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

Behavioral

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

Primary outcomes

  1. Self-efficacy Scale

    Time frame: 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

  2. Canadian Occupational Performance Measure (COPM)

    Time frame: 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.

  3. Caregiver Burden Scale

    Time frame: 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 outcomes

  1. Stroke Impact Scale (SIS) 3.0

    Time frame: 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'

  2. Frenchay Activities Index

    Time frame: 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).

  3. Fatigue Severity Scale-7

    Time frame: 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)

  4. Hospital Anxiety and Depression Scale

    Time frame: 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)

  5. Life Satisfaction Checklist

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Forte

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2020
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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