Clinical trial NCT03271788: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Relatives
Motor Disorder
Attention Deficit
Quality of Life
Lead sponsor: Zurich University of Applied Sciences
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

1. 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)
2. A-Phase The stroke patient continues his/her regular occupational treatment for eight weeks.

   The caregivers get no study-related treatment.
3. 2nd (Midterm)-Measurement Same procedure as the baseline measurement.
4. 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.
5. 3rd (Final) Measurement Same procedure as the baseline and second (Midterm-) measurement.

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

Primary outcomes:
measure: Wolf Motor Function Test
timeFrame: 20min
measure: Motor Activity LOG (MAL)
timeFrame: Time of performance: ca. 15 min
measure: Assessment of Motor and Process Skills (AMPS)
timeFrame: 50min
measure: ASPA (Attention and Performance Self-Assessment)
timeFrame: 5min
measure: WHOQoL-BREF (for patients and caregivers)
timeFrame: 20 min
measure: EQ-5D
timeFrame: 5 min
measure: Pictorial Representation of Illness and Self Measure (PRISM) (patients and caregivers)
timeFrame: 10min
measure: Burden Scale of family caregivers BSFC (Häusliche Pflegeskala) only caregivers
timeFrame: 10min
Secondary outcomes:
measure: Semi-structured Interview (patients and caregivers)
timeFrame: 60min
Other outcomes:
Locations:
Study officials:
affiliation: Zurich University of Applied Sciences
name: Silke Neumann, MSC
role: PRINCIPAL_INVESTIGATOR
References: