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

This study is currently recruiting participants.
Verified October 2012 by Bastyr University
Sponsor:
Information provided by (Responsible Party):
Laurie Mischley, Bastyr University
ClinicalTrials.gov Identifier:
NCT01703429
First received: October 3, 2012
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

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
Multiple Sclerosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bastyr University:

Primary Outcome Measures:
  • "CAM Therapies" survey [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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:
  • Modified Expanded Disability Severity Score (EDSS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The EDSS will be used to capture disease severity and rates of progression in this cohort.


Other Outcome Measures:
  • PROMIS: Global Health [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    This outcome measure will be used to assess general health and well-being in this CAM using cohort.


Estimated Enrollment: 1000
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Individuals with MS
Individuals who are using CAM therapies adjunctively or in lieu of conventional therapy (including, but not limited to, special diets, exercise, meditation, prayer, support groups, herbal therapies, counseling, etc.)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 survey every six (6) months. (~ 45 min)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01703429

Locations
United States, Washington
Bastyr University Clinical Research Center Recruiting
Kenmore, Washington, United States, 98028
Contact: Laurie K Mischley, ND    425-602-3306    neuroresearch@bastyr.edu   
Contact: Marco F Vespignani, ND    425-602-3309    mvespignani@bastyr.edu   
Principal Investigator: Laurie K Mischley, ND         
Sub-Investigator: Marco F Vespignani, ND         
Sponsors and Collaborators
Bastyr University
Investigators
Principal Investigator: Laurie K Mischley, ND Bastyr University
  More Information

Additional Information:
No publications provided

Responsible Party: Laurie Mischley, Clinical Research Assistant Professor, Bastyr University
ClinicalTrials.gov Identifier: NCT01703429     History of Changes
Other Study ID Numbers: BU-11A-1296
Study First Received: October 3, 2012
Last Updated: October 8, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 16, 2014