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Can Stroke Patients and Their Caregiver Benefit From Additive Mindfulness Training

Primary Purpose

Stroke, Relatives, Motor Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness, MBSR
Sponsored by
Zurich University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants (out-patients) fulfilling all of the following inclusion criteria are eligible for the study:
  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Adult stroke patients (outpatients) who gets regular occupational therapy
  • Time after stroke at least 6 months
  • Modified Rankin Scale ≥1≤ 4
  • Mini Mental State ≥ 24

Participants (caregivers) fulfilling all of the following inclusion criteria are eligible for the study:

  • Close relative who is primary in charge and bear the largest burden of the caregiving of the stroke patient

Exclusion Criteria:

  • Co-Morbidity (e.g. severe psychological, neurological disorders)
  • Severe cognitive disorders
  • Severe speech comprehension disorders
  • Known or suspected drug, medication or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    stroke patients and caregivers

    Arm Description

    Stroke patients will conduct two phases ( A-Phase: regular occupational therapy; B-Phase occupational therapy with additional mindfulness) Caregivers of the patients will conduct the MBSR Course (Mindfulness) together with their relatives (Phase B). In Phase A they will not receive any treatment.

    Outcomes

    Primary Outcome Measures

    Wolf Motor Function Test
    The Wolf Motor Function Test (WMFT) quantifies upper extremity (UE) motor ability through timed and functional tasks (Wolf et al., 1995). The first 6 items involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. Performance is rated on a scale (Wolf et al., 2005) from 1("does not attempt with UE being tested") to 6 ("appears normal"). Lower scores indicate lower functioning levels. Since a maximum of 120 s is allocated to each item, it is estimated to take approximately 30 min with additional time for measuring grip strength (item 14).
    Motor Activity LOG (MAL)
    The MAL is a scripted structured interview to measure real-works upper extremity function. Patients have to assess their capabilities of the upper limb in terms of How often do they use the affected limb in their everyday live and How would they evaluate the quality of the use? (Taub et al, 2011)
    Assessment of Motor and Process Skills (AMPS)
    The purpose of the AMPS is to evaluate a person's quality of performance of personal or instrumental activities of daily living (ADL) by observing the person doing the task (e.g. cooking a pancake, put on socks, etc.) The AMPS is used to test a person in a relevant and familiar environment as he or she performs ADL tasks that have been prioritized by the client. It measures the degree to which a person's ADL task performances are free of increased clumsiness or physical effort, decreased efficiency, safety risk, and/or need for assistance. It is possible to score the quality of 16 ADL motor and 20 ADL process performance skills and facilitate occupation-focused documentation and occupation-based intervention planning. (Downloaded from website: http://www.innovativeotsolutions.com/content/amps/ )
    ASPA (Attention and Performance Self-Assessment)
    The purpose of the self-assessment questionnaire ASPA is to evaluate and analyse a person's memory and attention that is necessary in everyday tasks.
    WHOQoL-BREF (for patients and caregivers)
    The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials. The WHOQOL-BREF self-assessment was completed, together with socio-demographic and health status questions. Analyses of internal consistency, item-total correlations, discriminant validity and construct validity through confirmatory factor analysis, indicate that the WHOQOL-BREF has well to excellent psychometric properties of reliability and performs well in preliminary tests of validity. These results indicate that overall, the WHOQOL-BREF is a sound, cross-culturally valid assessment of QOL (Skevington et al, 2004).
    EQ-5D
    EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D is designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics, and in face-to-face interviews. It is cognitively undemanding, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire (Oemar et al., 2013)
    Pictorial Representation of Illness and Self Measure (PRISM) (patients and caregivers)
    The PRISM is a tool used to represent the burden of an illness graphically.in relation to oneself and one's life measured with the Self-Illness-Separation (SIS) instrument (Streffer et al., 2009; Kassardjian et al., 2008)
    Burden Scale of family caregivers BSFC (Häusliche Pflegeskala) only caregivers
    The Burden Scale of Family Caregivers (BSFC) is a 28-item questionnaire developed ot measure the levels of perceived burden of family caregivers. The BSFC is designed for use to identify individual caregiver service needs, plan intervention, and evaluate progress in clinical practice. to evaluate service effectiveness of a program and to predict caregiver health and caregiving situation in research studies.

    Secondary Outcome Measures

    Semi-structured Interview (patients and caregivers)
    Different topics that are important for the patients and the caregivers will be discussed e.g. Change in family-roles and relationship, handling of dependencies Daily burden, strain, daily problems Coping strategies Etc.

    Full Information

    First Posted
    September 1, 2017
    Last Updated
    September 1, 2017
    Sponsor
    Zurich University of Applied Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03271788
    Brief Title
    Can Stroke Patients and Their Caregiver Benefit From Additive Mindfulness Training
    Official Title
    Pilot Study to Evaluate the Effect of MBSR on Motor Learning, Attention, and Quality of Life in Stroke Patients and Their Relatives- a Monocentric Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2017 (Anticipated)
    Primary Completion Date
    December 31, 2018 (Anticipated)
    Study Completion Date
    December 31, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zurich University of Applied Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The main purpose of the study is to find out if MBSR (Mindfulness) in addition to occupational therapy, can improve the therapeutic results in stroke-patients and help relatives of stroke patients to improve their quality of life.
    Detailed Description
    The study seeks primarily to determine the effect of Mindfulness (conducted additionally to occupational therapy) on physical and mental capabilities of life of stroke patients. Furthermore, we want to find out if Mindfulness has a positive impact towards the quality of life and the daily burden of stroke patients and their caregivers. The overall purpose of this study is to evaluate the feasibility of the process-basis, resources-basis, management-basis, and scientific basis for a further larger study. We want to conduct an exploratory case study as an A-B Design in which the A-Phase is "only regular occupational therapy" (no additive intervention) and the B-Phase contains the "regular occupational therapy" and "MBSR" (Mindfulness-Course; intervention). Four stroke patients and their closest relative will be included in the study (n=8). The study is non-blinded and no randomised allocation will take place. We will compare the outcomes of Phase B with the outcomes of Phase A of every person. The purpose of the exploratory case study is to analyse the feasibility of the study design that will be used in a subsequent research study. The study will last 16 weeks; split into two parts of eight weeks (A Phase and B-Phase). Baseline Measurement If the patient and the caregivers are included into the study they perform several measurements and questionnaires: Measurements to assess physical capabilities (Patient) Measurement to assess attention (Patient) Measurements to assess Quality of life daily burden of illness and caregiving (Patient and Caregiver Semi structured Interviews (Patient and Caregiver) A-Phase The stroke patient continues his/her regular occupational treatment for eight weeks. The caregivers get no study-related treatment. 2nd (Midterm)-Measurement Same procedure as the baseline measurement. B-Phase (Intervention Phase) Within the B-Phase of the study, the participant gets Mindfulness Training (intervention) in addition to the regular occupational therapy. Before Patients and Caregivers start the MBSR Course (Mindfulness) the get information from an experienced Mindfulness trainer about e.g. duration, contents of the course, etc. They have the opportunity to ask questions. The course lasts eight weeks. The MBSR group meet every week for 2.5h. The participants will get "homework" that they to perform at home (1h per day). If the duration of practice is to burdensome for the participants, then they can talk to the MBSR-trainer about time reduction. 3rd (Final) Measurement Same procedure as the baseline and second (Midterm-) measurement.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Relatives, Motor Disorder, Attention Deficit, Quality of Life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    8 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    stroke patients and caregivers
    Arm Type
    Experimental
    Arm Description
    Stroke patients will conduct two phases ( A-Phase: regular occupational therapy; B-Phase occupational therapy with additional mindfulness) Caregivers of the patients will conduct the MBSR Course (Mindfulness) together with their relatives (Phase B). In Phase A they will not receive any treatment.
    Intervention Type
    Other
    Intervention Name(s)
    Mindfulness, MBSR
    Intervention Description
    Participants (stroke patients and one of their closest relatives) will conduct an MBSR Course in Phase B
    Primary Outcome Measure Information:
    Title
    Wolf Motor Function Test
    Description
    The Wolf Motor Function Test (WMFT) quantifies upper extremity (UE) motor ability through timed and functional tasks (Wolf et al., 1995). The first 6 items involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. Performance is rated on a scale (Wolf et al., 2005) from 1("does not attempt with UE being tested") to 6 ("appears normal"). Lower scores indicate lower functioning levels. Since a maximum of 120 s is allocated to each item, it is estimated to take approximately 30 min with additional time for measuring grip strength (item 14).
    Time Frame
    20min
    Title
    Motor Activity LOG (MAL)
    Description
    The MAL is a scripted structured interview to measure real-works upper extremity function. Patients have to assess their capabilities of the upper limb in terms of How often do they use the affected limb in their everyday live and How would they evaluate the quality of the use? (Taub et al, 2011)
    Time Frame
    Time of performance: ca. 15 min
    Title
    Assessment of Motor and Process Skills (AMPS)
    Description
    The purpose of the AMPS is to evaluate a person's quality of performance of personal or instrumental activities of daily living (ADL) by observing the person doing the task (e.g. cooking a pancake, put on socks, etc.) The AMPS is used to test a person in a relevant and familiar environment as he or she performs ADL tasks that have been prioritized by the client. It measures the degree to which a person's ADL task performances are free of increased clumsiness or physical effort, decreased efficiency, safety risk, and/or need for assistance. It is possible to score the quality of 16 ADL motor and 20 ADL process performance skills and facilitate occupation-focused documentation and occupation-based intervention planning. (Downloaded from website: http://www.innovativeotsolutions.com/content/amps/ )
    Time Frame
    50min
    Title
    ASPA (Attention and Performance Self-Assessment)
    Description
    The purpose of the self-assessment questionnaire ASPA is to evaluate and analyse a person's memory and attention that is necessary in everyday tasks.
    Time Frame
    5min
    Title
    WHOQoL-BREF (for patients and caregivers)
    Description
    The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials. The WHOQOL-BREF self-assessment was completed, together with socio-demographic and health status questions. Analyses of internal consistency, item-total correlations, discriminant validity and construct validity through confirmatory factor analysis, indicate that the WHOQOL-BREF has well to excellent psychometric properties of reliability and performs well in preliminary tests of validity. These results indicate that overall, the WHOQOL-BREF is a sound, cross-culturally valid assessment of QOL (Skevington et al, 2004).
    Time Frame
    20 min
    Title
    EQ-5D
    Description
    EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D is designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics, and in face-to-face interviews. It is cognitively undemanding, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire (Oemar et al., 2013)
    Time Frame
    5 min
    Title
    Pictorial Representation of Illness and Self Measure (PRISM) (patients and caregivers)
    Description
    The PRISM is a tool used to represent the burden of an illness graphically.in relation to oneself and one's life measured with the Self-Illness-Separation (SIS) instrument (Streffer et al., 2009; Kassardjian et al., 2008)
    Time Frame
    10min
    Title
    Burden Scale of family caregivers BSFC (Häusliche Pflegeskala) only caregivers
    Description
    The Burden Scale of Family Caregivers (BSFC) is a 28-item questionnaire developed ot measure the levels of perceived burden of family caregivers. The BSFC is designed for use to identify individual caregiver service needs, plan intervention, and evaluate progress in clinical practice. to evaluate service effectiveness of a program and to predict caregiver health and caregiving situation in research studies.
    Time Frame
    10min
    Secondary Outcome Measure Information:
    Title
    Semi-structured Interview (patients and caregivers)
    Description
    Different topics that are important for the patients and the caregivers will be discussed e.g. Change in family-roles and relationship, handling of dependencies Daily burden, strain, daily problems Coping strategies Etc.
    Time Frame
    60min

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants (out-patients) fulfilling all of the following inclusion criteria are eligible for the study: Informed Consent as documented by signature (Appendix Informed Consent Form) Adult stroke patients (outpatients) who gets regular occupational therapy Time after stroke at least 6 months Modified Rankin Scale ≥1≤ 4 Mini Mental State ≥ 24 Participants (caregivers) fulfilling all of the following inclusion criteria are eligible for the study: Close relative who is primary in charge and bear the largest burden of the caregiving of the stroke patient Exclusion Criteria: Co-Morbidity (e.g. severe psychological, neurological disorders) Severe cognitive disorders Severe speech comprehension disorders Known or suspected drug, medication or alcohol abuse Inability to follow the procedures of the study, e.g. due to language
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Silke Neumann, MSc
    Phone
    0041 58 934 49 76
    Email
    neus@zhaw.ch
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heidrun Becker, Prof
    Phone
    0041 58 934 64 77
    Email
    heidrun.becker@zhaw.ch
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Silke Neumann, MSC
    Organizational Affiliation
    Zurich University of Applied Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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