Trial record 5 of 140 for:
complementary and alternative medicine | Open Studies
Complementary and Alternative Care in Multiple Sclerosis (CAM Care in MS)
This study is currently recruiting participants.
Verified October 2012 by Bastyr University
Sponsor:
Bastyr University
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
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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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
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 May 23, 2013