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CAM Care in MS: Complementary and Alternative Care in Multiple Sclerosis

Sponsor
Bastyr University (Other)
Overall Status
Recruiting
CT.gov ID
NCT01703429
Collaborator
(none)
1,000
Enrollment
1
Location
216
Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Jun 1, 2012
    Anticipated Primary Completion Date :
    Jun 1, 2030
    Anticipated Study Completion Date :
    Jun 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    Individuals with MS

    Outcome Measures

    Primary Outcome Measures

    1. "CAM Therapies" survey [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) [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 [5 years]

      This outcome measure will be used to assess general health and well-being in this CAM using cohort.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bastyr University Clinical Research Center Kenmore Washington United States 98028

    Sponsors and Collaborators

    • Bastyr University

    Investigators

    • Principal Investigator: Laurie K Mischley, ND, PhD, MPH, Bastyr University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Laurie Mischley, Clinical Research Assistant Professor, Bastyr University
    ClinicalTrials.gov Identifier:
    NCT01703429
    Other Study ID Numbers:
    • BU-11A-1296
    First Posted:
    Oct 10, 2012
    Last Update Posted:
    Feb 11, 2020
    Last Verified:
    Feb 1, 2020
    Keywords provided by Laurie Mischley, Clinical Research Assistant Professor, Bastyr University
    Multiple Sclerosis
    MS
    Complementary and Alternative
    CAM
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Feb 11, 2020