Multiple System Atrophy Multidisciplinary Clinic
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03811808|
Recruitment Status : Recruiting
First Posted : January 21, 2019
Last Update Posted : January 21, 2019
|Condition or disease|
|Multiple System Atrophy (MSA)|
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
- MDS Scale
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Multiple System Atrophy Multidisciplinary Clinic|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2026|
|Estimated Study Completion Date :||March 2026|
patients diagnosed with possible or probable multiple system atrophy
- 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.
- 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.
- 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.
- 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
- 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.
- 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).
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
|Contact: GIselle Huet, M.S., CCRP||Giselle.Huet@utsouthwestern.edu|
|Contact: Xiaohong XU, M.S., CCRC||2146486882||Xiaohong.Xu@utsouthwestern.edu|
|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|
|Principal Investigator:||Steven Vernino, M.D.||UT Southwestern Medical Center|