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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Energy conservation education | Experimental | Participants received 6-70 minute group teleconference sessions with an occupational therapist facilitator. The intervention provided education, guided discussion, and peer support for learning about and applying energy conservation principles |
|
| Wait list control | Other | Participants received 6-70 minute group teleconference sessions with an occupational therapist facilitator. The intervention provided education, guided discussion, and peer support for learning about and applying energy conservation principles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy conservation education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, 7 weeks (immediate post-intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcia L Finlayson, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21561960 | Result | Finlayson M, Preissner K, Cho C, Plow M. Randomized trial of a teleconference-delivered fatigue management program for people with multiple sclerosis. Mult Scler. 2011 Sep;17(9):1130-40. doi: 10.1177/1352458511404272. Epub 2011 May 11. | |
| 22394528 | Derived | Finlayson M, Preissner K, Cho C. Outcome moderators of a fatigue management program for people with multiple sclerosis. Am J Occup Ther. 2012 Mar-Apr;66(2):187-97. doi: 10.5014/ajot.2012.003160. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Group | Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation. |
| FG001 | Wait List | Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Group | Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation. |
| BG001 | Wait List | Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Intent-to-treat, imputation by maximum likelihood approach | Posted | Mean | Standard Deviation | units on a scale | baseline, 7 weeks (immediate post-intervention) |
|
Potential adverse events were monitored throughout the study, from baseline through to the final follow-up at 6 months post-intervention.
No adverse events were observed at any point during the study, from baseline through to the final follow-up at 6 months post-intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Group | Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation. |
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Use of self-report rather than objective measures of MS disability. Only the participants were blinded to their allocation status. Co-intervention was tracked, but there is no way to know whether other interventions contributed to the results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcia Finlayson, PhD | University of Illinois at Chicago | 312-996-4603 | marciaf@uic.edu |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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|
| Intervention not received |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation. |
| OG001 | Wait List | Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management) |
|
|
|
| 0 |
| 89 |
| 0 |
| 89 |
| EG001 | Wait List | Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management) | 0 | 92 | 0 | 92 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |