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NCT01918800 · ClinicalTrials.gov registry record · NA
A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 282
- Enrollment target
NCT01918800: Completed NA study, sponsored by VA Office of Research and Development.
NCT01918800 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 282 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01918800, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 282 participants
- Enrollment target
Study 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.
Primary Outcome
The self-report, retrospective MFIS measures fatigue symptoms. The full-length MFIS consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of .81. The MFIS provides a total score and scores for each of three subscales (physical, cognitive and psychosocial) and lower scores on the MFIS and its subscales indicate less fatigue. This is the primary outcome measure for the proposed study and is widely used to assess fatigue in MS.
Interventions
- BEHAVIORAL Fatigue: Take control
- BEHAVIORAL MS: Take Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 282 participants |
| Start Date | 2013-03-28 |
| Est. Completion | 2015-12-30 |
| Phase | NA |
What the finished NCT01918800 record still lists
NCT01918800 is an interventional study that assigns participants to a tested intervention. The registered 282 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Fatigue: Take control is the first listed.
NCT01918800 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01918800 about?
NCT01918800 is a clinical study titled "A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis". 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, numb...
What is the current status of trial NCT01918800?
This trial is currently completed. It is a NA study. The enrollment target is 282 participants. The study started on 2013-03-28. Estimated completion is 2015-12-30.
What interventions are being tested in trial NCT01918800?
The interventions under investigation include: Fatigue: Take control (BEHAVIORAL), MS: Take Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT01918800?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01918800's enrollment target sits among peer trials
282 379th of 2000 higher than 1,621 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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