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Complementary and Alternative Care in Multiple Sclerosis (CAM Care in MS)

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ClinicalTrials.gov Identifier: NCT01703429
Recruitment Status : Recruiting
First Posted : October 10, 2012
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Laurie Mischley, Bastyr University

Brief Summary:
This is a prospective, observational study designed to describe disease progression, symptom change, quality of life, diet and lifestyle habits, and frequency of adverse events among patients with multiple sclerosis (MS) who use complementary and alternative medicine (CAM). In addition to describing the patterns of CAM use, this study will also identify and describe the positive deviants, those individuals with the highest quality of life and least amount of disease activity. Positive deviants will be compared to controls in order to describe medication, diet, and lifestyle patterns associated with a lack of MS disease progression and high quality of life.

Condition or disease
Multiple Sclerosis

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Complementary and Alternative Medicine (CAM) in Multiple Sclerosis. A Prospective Observational Study of a CAM-using Cohort
Study Start Date : June 2012
Estimated Primary Completion Date : June 2040
Estimated Study Completion Date : June 2040

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Individuals with MS



Primary Outcome Measures :
  1. "CAM Therapies" survey [ Time Frame: 5 years ]
    This survey has been developed to identify the complementary and alternative therapies most commonly used by individuals with MS. Results will be reported with descriptive statistics.


Secondary Outcome Measures :
  1. Modified Expanded Disability Severity Score (EDSS) [ Time Frame: 5 years ]
    The EDSS will be used to capture disease severity and rates of progression in this cohort.


Other Outcome Measures:
  1. PROMIS: Global Health [ Time Frame: 5 years ]
    This outcome measure will be used to assess general health and well-being in this CAM using cohort.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any individual with multiple sclerosis is invited to participate.
Criteria

Inclusion Criteria:

  • Diagnosis of multiple sclerosis (including relapsing remitting MS, secondary progressive MS, primary progressive MS, clinically isolated syndromes (CIS), radiologically-isolated syndromes (RIS), possible MS, or probable MS.
  • Age 18-100

Exclusion Criteria:

  • Inability to read/write in English
  • Inability or unwillingness to complete surveys every six (6) months. (~ 90 min)

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): NCT01703429


Locations
United States, Washington
Bastyr University Clinical Research Center Recruiting
Kenmore, Washington, United States, 98028
Contact: Laurie K Mischley, ND, MPH    425-602-3306    neuroresearch@bastyr.edu   
Principal Investigator: Laurie K Mischley, ND, MPH         
Sponsors and Collaborators
Bastyr University
Investigators
Principal Investigator: Laurie K Mischley, ND, MPH Bastyr University

Additional Information:
Responsible Party: Laurie Mischley, Clinical Research Assistant Professor, Bastyr University
ClinicalTrials.gov Identifier: NCT01703429     History of Changes
Other Study ID Numbers: BU-11A-1296
First Posted: October 10, 2012    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017

Keywords provided by Laurie Mischley, Bastyr University:
Multiple Sclerosis
MS
Complementary and Alternative
CAM

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases