Multiple Sclerosis
Conditions
Keywords
energy conservation education, occupational therapy intervention, fatigue management, psychoeducation
Brief summary
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.
Interventions
BEHAVIORALEnergy conservation education
The intervention for this study is a group-based educational program delivered by teleconference to 4-6 individuals with MS by a licensed occupational therapist. The program involves 6 weekly sessions. Each session is 1 hour and 15 minutes in duration. Key topics addressed include: importance of rest, positive and effective communication, modification of the environment, using equipment and technology, setting priorities, and activity analysis and modification. Direct instruction, group discussion, and peer support are key elements of the program. Participants receive a manual with application activities that are completed in between sessions.
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Subscale Scores of the Fatigue Impact Scale | baseline, 7 weeks (immediate post-intervention) | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Immediate Group Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation. | 89 |
| Wait List Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management) | 92 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Intervention not received | 10 | 8 |
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Withdrawal by Subject | 10 | 10 |
Baseline characteristics
| Characteristic | Wait List | Immediate Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 7 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 83 Participants | 82 Participants | 165 Participants |
| Age Continuous | 53.5 years STANDARD_DEVIATION 9.7 | 53.5 years STANDARD_DEVIATION 9.1 | 53.5 years STANDARD_DEVIATION 8.9 |
| Region of Enrollment United States | 92 participants | 89 participants | 181 participants |
| Sex: Female, Male Female | 70 Participants | 73 Participants | 143 Participants |
| Sex: Female, Male Male | 22 Participants | 16 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 89 | 0 / 92 |
| serious Total, serious adverse events | 0 / 89 | 0 / 92 |
Outcome results
Primary
Change From Baseline in Subscale Scores of the Fatigue Impact Scale
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
Time frame: baseline, 7 weeks (immediate post-intervention)
Population: Intent-to-treat, imputation by maximum likelihood approach
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Group | 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 |
| Immediate Group | 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 |
| Immediate Group | 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 |
| Wait List | Change From Baseline in Subscale Scores of the Fatigue Impact Scale | Average Change in Cognitive Subscale Score | -1.11 units on a scale | Standard Deviation 6.18 |
| Wait List | Change From Baseline in Subscale Scores of the Fatigue Impact Scale | Average Change in Physical Subscale Scores | -1.22 units on a scale | Standard Deviation 6.24 |
| Wait List | Change From Baseline in Subscale Scores of the Fatigue Impact Scale | Average Change in Psychosocial Subscale Score | -2.38 units on a scale | Standard Deviation 12.4 |
Comparison: Hypothesis: Individuals who participate in the program will report significantly reduced fatigue impact immediately post-intervention compared to individuals allocated to the wait-list control group.p-value: <0.0595% CI: [-15.47, 10.41]t-test, 2 sided