Effectiveness of a Teleconference Delivered Fatigue Management Program for People With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT00591721

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Change From Baseline in Subscale Scores of the Fatigue Impact ScaleMean Difference (Net) -2.53-15.47–10.41<0.05

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Energy conservation education

Results by group

Change From Baseline in Subscale Scores of the Fatigue Impact Scale

baseline, 7 weeks (immediate post-intervention)

GroupValueIntervalNumber analysed
Immediate Group-3.74 units on a scale6.74 (Standard Deviation)89
Wait List-1.22 units on a scale6.24 (Standard Deviation)92
Immediate Group-4.24 units on a scale6.01 (Standard Deviation)89
Wait List-1.11 units on a scale6.18 (Standard Deviation)92
Immediate Group-8.39 units on a scale11.66 (Standard Deviation)89
Wait List-2.38 units on a scale12.4 (Standard Deviation)92

p = <0.05; Mean Difference (Net) -2.53 (95% CI -15.47–10.41)

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Immediate Group890 (0.0%)
Wait List920 (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 Subscale Scores of the Fatigue Impact Scale

    baseline, 7 weeks (immediate post-intervention)

    Thinking and memoryFatigue

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* a diagnosis of MS * 18 years of age or older * functional English literacy (i.e., able to read course materials and carry on telephone conservations in English) * Fatigue Severity Scale score of 4 or greater * Residing in the state of Illinois

Exclusion criteria

* Short version - Blessed Orientation Memory Concentration Test - outside of normal range

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

About this trial

In the sponsor's words

Approximately 60% of individuals with multiple sclerosis (MS) describe fatigue as their most disabling symptom. Energy conservation education involves teaching people with MS different strategies to manage fatigue and reduce its impact on daily life. Despite growing evidence of the effectiveness of face-to-face energy conservation education, not all people with MS are able to access these programs. The purpose of this project is to test the effectiveness and efficacy of a teleconference-delivered energy conservation education program for people with MS. The primary goals of the project are to reduce the impact of fatigue on participants' everyday lives, reduce fatigue severity, and improve quality of life. Secondary goals are to increase self-efficacy for managing fatigue and increase the number of energy conservation strategies used. The study will employ a randomly allocated two group time series design with a wait-list control group, which is one type of randomized control trial. A total of 181 people with MS will be recruited through direct mailing and advertising. The program will be delivered by telephone teleconference by a licensed occupational therapist. Outcome measures will be administered over the telephone by a research assistant before and after the program, at three months and at six months. We hypothesize that: (1) individuals in the immediate intervention group achieve better outcomes than individuals in the wait-list control group; (2) the program leads to significant reductions in fatigue impact and fatigue severity, and improved quality of life; and (3) improvements in the outcomes can be maintained over six months.

Papers

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History

    1. Started

      Nov 2007

    2. Main results due

      Feb 2010

    3. Finished

      Feb 2010

    4. Results posted

      Feb 2013

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