Trial Outcomes & Findings for Teleconference Fatigue Management for People With Multiple Sclerosis (NCT NCT00591721)
NCT ID: NCT00591721
Last Updated: 2013-02-28
Results Overview
Fatigue impact was measured using the "Fatigue Impact Scale (FIS)" (Fisk et al, 1994). This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rate each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score (range from 0 to 160) and three subscale scores (physical - 10 items, score range 0 to 40; psychosocial - 20 items, score range 0 to 80; cognitive - 10 items, score range 0-40) can be produced from participants' responses. Higher scores reflect greater fatigue impact. What is reported here is the mean individual differences in the 7 week post subscale scores minus the baseline subscale scores
COMPLETED
NA
190 participants
baseline, 7 weeks (immediate post-intervention)
2013-02-28
Participant Flow
Recruitment occurred between November 2007 and April 2009 and involved the distribution of advertising through the MS Society and to Illinois residents participating in the NARCOMS volunteer MS patient registry.
190 individuals were enrolled in the study (i.e., signed consent forms), but 9 of them did not complete baseline measures. Therefore 181 continued through the study.
Participant milestones
| Measure |
Immediate Group
Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
|
Wait List
Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
92
|
|
Overall Study
COMPLETED
|
68
|
70
|
|
Overall Study
NOT COMPLETED
|
21
|
22
|
Reasons for withdrawal
| Measure |
Immediate Group
Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
|
Wait List
Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
10
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Intervention not received
|
10
|
8
|
Baseline Characteristics
Teleconference Fatigue Management for People With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Immediate Group
n=89 Participants
Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
|
Wait List
n=92 Participants
Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
82 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age Continuous
|
53.5 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=5 Participants
|
92 participants
n=7 Participants
|
181 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 7 weeks (immediate post-intervention)Population: Intent-to-treat, imputation by maximum likelihood approach
Fatigue impact was measured using the "Fatigue Impact Scale (FIS)" (Fisk et al, 1994). This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rate each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score (range from 0 to 160) and three subscale scores (physical - 10 items, score range 0 to 40; psychosocial - 20 items, score range 0 to 80; cognitive - 10 items, score range 0-40) can be produced from participants' responses. Higher scores reflect greater fatigue impact. What is reported here is the mean individual differences in the 7 week post subscale scores minus the baseline subscale scores
Outcome measures
| Measure |
Immediate Group
n=89 Participants
Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
|
Wait List
n=92 Participants
Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
|
|---|---|---|
|
Change From Baseline in Subscale Scores of the Fatigue Impact Scale
Average Change in Physical Subscale Scores
|
-3.74 units on a scale
Standard Deviation 6.74
|
-1.22 units on a scale
Standard Deviation 6.24
|
|
Change From Baseline in Subscale Scores of the Fatigue Impact Scale
Average Change in Cognitive Subscale Score
|
-4.24 units on a scale
Standard Deviation 6.01
|
-1.11 units on a scale
Standard Deviation 6.18
|
|
Change From Baseline in Subscale Scores of the Fatigue Impact Scale
Average Change in Psychosocial Subscale Score
|
-8.39 units on a scale
Standard Deviation 11.66
|
-2.38 units on a scale
Standard Deviation 12.40
|
Adverse Events
Immediate Group
Wait List
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marcia Finlayson, PhD
University of Illinois at Chicago
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place