CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 282 enrolled
Drug / intervention
Fatigue: Take control +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01918800
NCT01918800N/ACompleted

A Randomized Trial of a Formal Group Program for Fatigue in Multiple Sclerosis

VA Office of Research and Development·interventional·Posted Aug 8, 2013·Updated Jul 26, 2018

In Brief

A clinical study evaluating Fatigue: Take control and MS: Take Control for Multiple Sclerosis. Completed, enrolled 282 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 8, 2013
Enrollment StartMar 28, 2013
Primary CompletionDec 30, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.9 years ago

Interventions

Fatigue: Take controlbehavioral

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

MS: Take Controlbehavioral

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