Multiple System Atrophy Multidisciplinary Clinic
ConditionMultiple System Atrophy (MSA)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients that are unable to give consent
Minor patients (younger than age 18)
Non-English speaking patients
Subjects that are diagnosed with dementia
Trial population
Adults 18 years or older with diagnosis of possible or probable MSA
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: MSA patients
Trial outcomes
Primary outcomes
1
Multiple System Atrophy-Quality of Life (MSA-QoL)
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.
Time frame
at 5 year evaluationSecondary outcomes
1
Unified Multiple System Atrophy Rating Scale (UMSARS)
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.
Time frame
at 5 year evaluation2
Caregiver Burden Index/ The Zarit Burden Interview
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.
Time frame
at 5 year evaluationOther outcomes
1
Composite Autonomic Symptom Score (CONPASS 31)
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
Time frame
at 5 year evaluation2
Center for Epidemiologic Studies Depression Scale (CES-D)
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.
Time frame
at 5 year evaluation3
The Orthostatic Hypotension Questionnaire (OHQ)
The OHQ is used to assess the comprehensive symptom burden and severity of neurogenic orthostatic hypotension (NOH).
Time frame
at 5 year evaluationSponsors and contacts
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Source ClinicalTrials.gov