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

Study Locations

    • Washington
      • Kenmore, Washington, United States, 98028
        • Recruiting
        • Bastyr University Clinical Research Center
        • Contact:
        • 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.

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

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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