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A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis

NCT01918800 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2018-07-26

Study results available
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Summary

The purpose of this study is to compare two different educational programs for people with multiple sclerosis (MS), which is a common and often disabling disease of the central nervous system. MS causes many symptoms including difficulty walking, loss of balance or muscle coordination, fatigue, numbness and tingling and stiffness. The investigators want to determine which program is better at helping improve quality of life and MS symptoms. Both programs use material from the National Multiple Sclerosis Society (NMSS). Both programs include 6 weekly 2-hour class sessions. Up to 600 participants will be enrolled total in 4 VA sites, with about 150 at each site. There will be 10 study visits, all to occur within 11 months. These include 1 baseline visit, 6 two-hour class visits, and 3 follow-up data collection visits. The participants in Portland will also participate in a final 12 month followup visit. Participants will be randomly (by chance) assigned to be part of either group education program. They will have a 1:1 or 50% chance of being in either program.

Conditions

Interventions

BEHAVIORAL

Fatigue: Take control

Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline

BEHAVIORAL

MS: Take Control

MS: Take Control includes topics of interest to people with MS other than fatigue.

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Dennis N Bourdette, MD · VA Portland Health Care System, Portland, OR

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-28
Primary Completion
2015-12-30
Completion
2015-12-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01918800 on ClinicalTrials.gov