- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01703429
Complementary and Alternative Care in Multiple Sclerosis (CAM Care in MS)
February 7, 2020 updated by: Laurie Mischley, Bastyr University
Complementary and Alternative Medicine (CAM) in Multiple Sclerosis. A Prospective Observational Study of a CAM-using Cohort
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Research Assistant
- Email: neuroresearch@bastyr.edu
Study Locations
-
-
Washington
-
Kenmore, Washington, United States, 98028
- Recruiting
- Bastyr University Clinical Research Center
-
Contact:
- Laurie K Mischley, ND, PhD, MPH
- Phone Number: 425-602-3306
- Email: neuroresearch@bastyr.edu
-
Principal Investigator:
- Laurie K Mischley, ND, PhD, MPH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Any individual with multiple sclerosis is invited to participate.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Individuals with MS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"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.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laurie K Mischley, ND, PhD, MPH, Bastyr University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Anticipated)
June 1, 2030
Study Completion (Anticipated)
June 1, 2030
Study Registration Dates
First Submitted
October 3, 2012
First Submitted That Met QC Criteria
October 8, 2012
First Posted (Estimate)
October 10, 2012
Study Record Updates
Last Update Posted (Actual)
February 11, 2020
Last Update Submitted That Met QC Criteria
February 7, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BU-11A-1296
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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