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Trial record 4 of 91 for:    "Brain Diseases" AND "Multiple System Atrophy"

Multiple System Atrophy Multidisciplinary Clinic

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ClinicalTrials.gov Identifier: NCT03811808
Recruitment Status : Recruiting
First Posted : January 21, 2019
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
This is a prospective cohort study to examine the disease burden of multiple system atrophy and the impact of multidisciplinary care on quality of life and caregiver burden. Data will be collected through valid rating scales completed by patients and caregivers at home or in the MSA clinic.

Condition or disease
Multiple System Atrophy (MSA)

Detailed Description:

Study Procedures:

Participants and caregivers will attend a multidisciplinary MSA clinic one day every four months. In addition to the standard of care, they will be asked to complete both online and paper questionnaires, including the following:

  • UMSARS (Unified MSA Rating Scale)
  • MSA QOL
  • CES-D
  • OHQ
  • Compass-31
  • BIC
  • UPDRS
  • SARA
  • MDS Scale
  • CGI
  • MoCA

Participants will be part of the study as long as they are a patient of the MSA clinic, and will be contacted for follow-up information up to five years.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multiple System Atrophy Multidisciplinary Clinic
Study Start Date : March 2016
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Group/Cohort
MSA patients
patients diagnosed with possible or probable multiple system atrophy



Primary Outcome Measures :
  1. Multiple System Atrophy-Quality of Life (MSA-QoL) [ Time Frame: at 5 year evaluation ]
    The disease burden of MSA and impact of multidisciplinary care on the quality of life of patients as measured by the MSA-Quality of Life (QOL) questionnaire completed every four months by the patients. The scale measures how MSA affects a person's quality of life in day to day activities. The scale ranges from No problem to Extreme Problem. The More Extreme Problem sections selected the more their quality of life is affected by the disease.


Secondary Outcome Measures :
  1. Unified Multiple System Atrophy Rating Scale (UMSARS) [ Time Frame: at 5 year evaluation ]
    The UMSARS completed every four months by the physician. The scale measures how MSA has progressed from baseline. The higher the score the higher the progression is.

  2. Caregiver Burden Index/ The Zarit Burden Interview [ Time Frame: at 5 year evaluation ]
    The disease burden of MSA and impact of multidisciplinary care on caregiver burden as measured by the Burden Index of Caregivers (BIC) questionnaire and The Zarit Burden Interview completed every four months by the caregivers. The higher the higher the score the more burden the caregiver has.


Other Outcome Measures:
  1. Composite Autonomic Symptom Score (CONPASS 31) [ Time Frame: at 5 year evaluation ]
    Compass 31 scale includes 31 questions and it will be used to assess autonomic symptoms that provides clinically relevant scores of autonomic symptom severity based. The higher the score the more autonomic symptoms present

  2. Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: at 5 year evaluation ]
    The CES-D measures symptoms defined by the American Psychiatric Association' Diagnostic and Statistical Manual (DSM-V) for a major depressive episode. The higher the scores and indicative for depression present.

  3. The Orthostatic Hypotension Questionnaire (OHQ) [ Time Frame: at 5 year evaluation ]
    The OHQ is used to assess the comprehensive symptom burden and severity of neurogenic orthostatic hypotension (NOH).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults 18 years or older with diagnosis of possible or probable MSA
Criteria

Inclusion Criteria:

  • Subject must be a patient in the UT Southwestern MSA clinic and be able to attend the multidisciplinary clinic every 4 months
  • Patients with possible or probable MSA based on established criteria
  • Subjects must be 18 years or older

Exclusion Criteria:

  • Patients that are unable to give consent
  • Minor patients (younger than age 18)
  • Non-English speaking patients
  • Subjects that are diagnosed with dementia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811808


Contacts
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Contact: GIselle Huet, M.S., CCRP Giselle.Huet@utsouthwestern.edu
Contact: Xiaohong XU, M.S., CCRC 2146486882 Xiaohong.Xu@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Giselle Huet, M.S., CCRP    214-648-9464    Giselle.Huet@utsouthwestern.edu   
Contact: Xiaohong XU, M.S.CCRP    2146486882    Xiaohong.Xu@utsouthwestern.edu   
Principal Investigator: Steven Vernino, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Steven Vernino, M.D. UT Southwestern Medical Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03811808     History of Changes
Other Study ID Numbers: STU 082015-008
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Brain Diseases
Atrophy
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases