Complementary and Alternative Care in Multiple Sclerosis | NCT01703429

Studies
Complementary and Alternative Care in Multiple Sclerosis

NCT01703429

Sponsor

Bastyr University

Status

Recruiting

Last Update Posted

Feb 11, 2020Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 2030Estimated

Completion Date

Jun 2030Estimated

First Submitted Date

Oct 3, 2012

First Submission Date that Met QC Criteria

Oct 8, 2012

First Posted Date

Oct 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2020

Last Update Posted Date

Feb 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Label	Type	Description	Intervention Names
Individuals with MS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
"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

Measure	Description	Time Frame
Modified Expanded Disability Severity Score (EDSS)	The EDSS will be used to capture disease severity and rates of progression in this cohort.	5 years

Other Outcomes

Measure	Description	Time Frame
PROMIS: Global Health	This outcome measure will be used to assess general health and well-being in this CAM using cohort.	5 years

Eligibility Module

Eligibility 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 surveys every six (6) months. (~ 90 min)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Any individual with multiple sclerosis is invited to participate.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Research Assistant	Contact			neuroresearch@bastyr.edu

Overall Officials

Name	Affiliation	Role
Laurie K Mischley, ND, PhD, MPH	Bastyr University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bastyr University Clinical Research Center	Recruiting	Kenmore	Washington	98028	United States

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided