NCT01703429

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Jun 2012Jun 2030

Study Start

First participant enrolled

June 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 10, 2012

Completed
17.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

18 years

First QC Date

October 3, 2012

Last Update Submit

February 7, 2020

Conditions

Keywords

Multiple SclerosisMSComplementary and AlternativeCAM

Outcome Measures

Primary Outcomes (1)

  • "CAM Therapies" survey

    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 Outcomes (1)

  • Modified Expanded Disability Severity Score (EDSS)

    5 years

Other Outcomes (1)

  • PROMIS: Global Health

    5 years

Study Arms (1)

Individuals with MS

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any individual with multiple sclerosis is invited to participate.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bastyr University Clinical Research Center

Kenmore, Washington, 98028, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Laurie K Mischley, ND, PhD, MPH

    Bastyr University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Assistant

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Assistant Professor

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 10, 2012

Study Start

June 1, 2012

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations