Comparing the Effectiveness of Fatigue Management Programs for People With MS

CompletedNot a drug-phase studyMS (type not specified)NCT03550170

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Teleconference
  • Internet
  • 1-to-1, in-person or videoconference

Results by group

Change From Baseline in Fatigue Levels

Change from baseline to 6 months

GroupValueIntervalNumber analysed
Teleconference50.98 score on a scale2.08 (Standard Deviation)196
Internet56.88 score on a scale0.59 (Standard Deviation)197
One-to-one57.87 score on a scale1.34 (Standard Deviation)197

Teleconference

50.98

Internet

56.88

One-to-one

57.87

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Teleconference1960 (0.0%)0
Internet1970 (0.0%)0
One-to-One1970 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Change From Baseline in Fatigue Levels

    Change from baseline to 6 months

    Fatigue

Other measures (1)

  • Change From Baseline in Health-related Quality of Life: Psychological Composite

    Change from baseline to 6 months

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* Self-report diagnosis of MS * Age ≥ 18 years * Fatigue Severity Scale score ≥ 4 * Ability to speak English

Exclusion criteria

* Individual must be capable of providing consent (Assessed with questionnaire) * Unable to access the internet or unable to travel to in-person sessions

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This is a multi-site randomized clinical trial comparing 3 modes of delivering the Managing Fatigue course for reducing fatigue in individuals with multiple sclerosis (MS). The primary hypothesis is that the teleconference and internet versions of the course will be noninferior to the one-on-one, in person version in terms of the primary outcome of fatigue and secondary outcome of quality of life.

Papers

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Linked trials

Links found where a registry record names another trial's registry number.

History

    1. Started

      Mar 2019

    2. Main results due

      Apr 2023

    3. Finished

      Apr 2023

    4. Results posted

      Sept 2024

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