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
About this trial
This is an interventional treatment trial for Stroke
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
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
NCT ID
NCT03271788
First Posted
September 1, 2017
Last Updated
September 1, 2017
Sponsor
Zurich University of Applied Sciences
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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