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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| University of Illinois at Chicago | OTHER |
| University of Minnesota | OTHER |
| Queen's University, Kingston, Ontario |
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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.
Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). MS fatigue can impact all aspects of quality of life, including physical, mental, and social function. MS fatigue is a profound barrier to participating in meaningful activities, such as employment and hobbies. Currently, the FDA has not approved medications for MS fatigue in the United States (US). However, there are empirically tested, non-pharmacological strategies that can support people with MS in reducing the impact of fatigue. Thus, the aim of the study is to compare 3 modes of delivering the Managing Fatigue course-2 telerehabilitation formats (teleconference and internet) and 1-to-1, in-person format (traditional mode of clinical service delivery)-upon outcomes important to people with MS, i.e., fatigue and its impact on physical, mental, and social function. The intervention arms will focus on reducing fatigue as a strategy to directly improve physical, mental and social functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teleconference | Active Comparator | Teleconference Intervention arm |
|
| Internet | Active Comparator | Internet Intervention arm |
|
| I-to-1, in-person or videoconference | Active Comparator | 1-to-1, in-person or videoconference intervention arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teleconference | Behavioral | This intervention arm will be a 6-week, group-based course involving weekly 80-min teleconference sessions. It will be delivered in small groups (6-12 participants) to maximize participants' opportunities for interaction. A program manual divided into 6 sections, 1 for each week that includes worksheets and homework activities will be given to the participants. Occupational therapists will facilitate the sessions. Participants and the OT will dial into 1-800 conference call line on the designated date and time. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fatigue Levels | Fatigue will be assessed with Fatigue Impact Scale. Fatigue Impact Scale is a 40-item questionnaire that measures impact of fatigue on day-to-day life. Scale ranges from "no problem" (0) to "extreme problem" (4). Total scores will be computed by summing responses for each item. Scores can range from 0 to 160 with a higher score indicating worse fatigue. | Change from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Health-related Quality of Life: Psychological Composite | Multiple Sclerosis Impact Scale (MSIS) was used to measure health-related quality of life. It consists of 29 self-report questions. The psychological composite score is calculated on a scale between 1 and 100. Higher scores indicate worse health-related quality of life. | Change from baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Plow, PhD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States | ||
| University of Minnesota |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32801193 | Derived | Plow M, Packer T, Mathiowetz VG, Preissner K, Ghahari S, Sattar A, Bethoux F, Finlayson M. REFRESH protocol: a non-inferiority randomised clinical trial comparing internet and teleconference to in-person 'Managing Fatigue' interventions on the impact of fatigue among persons with multiple sclerosis. BMJ Open. 2020 Aug 16;10(8):e035470. doi: 10.1136/bmjopen-2019-035470. |
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Enrolled participants would only be excluded from the study before assignment to groups if they did not meet the inclusion criteria stated in the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teleconference | Teleconference Intervention arm Teleconference: This intervention arm will be a 6-week, group-based course involving weekly 80-min teleconference sessions. It will be delivered in small groups (6-12 participants) to maximize participants' opportunities for interaction. A program manual divided into 6 sections, 1 for each week that includes worksheets and homework activities will be given to the participants. Occupational therapists will facilitate the sessions. Participants and the OT will dial into 1-800 conference call line on the designated date and time. |
| FG001 | Internet | Internet Intervention arm Internet: The internet course is similar to the teleconference format. It will occur in a 6-week period and be group based; i.e., 8-12 participants will begin the intervention at the same time and interact with each other during the 6-week period. Participants will be given a username and a password to view a different session each week at a time convenient for them. Each session will include completing practice activities and sharing information (e.g., offering advice and support to one another through the discussion forum). OTs will facilitate the discussions by responding to entries, asking questions, and providing encouragement to complete sessions. |
| FG002 | One-to-One | One-to-one intervention arm: Unlike the teleconference and internet courses, the number and length of sessions for the one-to-one course will vary over the 6-week period. The OT will cover all 6 topics, but the pace will be tailored to the participants' needs and preferences. Thus, although the topics are consistent, OTs are able to spend more time on topics that participants find pertinent to their situations. The participant and OT will be instructed to meet at least 3 times with at least 7 days between each session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Teleconference | Teleconference Intervention arm Teleconference: This intervention arm will be a 6-week, group-based course involving weekly 80-min teleconference sessions. It will be delivered in small groups (6-12 participants) to maximize participants' opportunities for interaction. A program manual divided into 6 sections, 1 for each week that includes worksheets and homework activities will be given to the participants. Occupational therapists will facilitate the sessions. Participants and the OT will dial into 1-800 conference call line on the designated date and time. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Fatigue Levels | Fatigue will be assessed with Fatigue Impact Scale. Fatigue Impact Scale is a 40-item questionnaire that measures impact of fatigue on day-to-day life. Scale ranges from "no problem" (0) to "extreme problem" (4). Total scores will be computed by summing responses for each item. Scores can range from 0 to 160 with a higher score indicating worse fatigue. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 6 months |
|
Adverse event data was collected during the course of data collection for each participant, which was 6 months long.
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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 | Teleconference | Teleconference Intervention arm Teleconference: This intervention arm will be a 6-week, group-based course involving weekly 80-min teleconference sessions. It will be delivered in small groups (6-12 participants) to maximize participants' opportunities for interaction. A program manual divided into 6 sections, 1 for each week that includes worksheets and homework activities will be given to the participants. Occupational therapists will facilitate the sessions. Participants and the OT will dial into 1-800 conference call line on the designated date and time. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Plow | Case Western Reserve University | 216-368-8969 | map208@case.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2019 | May 24, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| 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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| ID | Term |
|---|---|
| D000072638 | Patient Portals |
| ID | Term |
|---|---|
| D055991 | Health Records, Personal |
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
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| OTHER |
| Dalhousie University | OTHER |
| The Cleveland Clinic | OTHER |
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|
| Internet | Behavioral | The internet course is similar to the teleconference format. It will occur in a 6-week period and be group based; i.e., 8-12 participants will begin the intervention at the same time and interact with each other during the 6-week period. Participants will be given a username and a password to view a different session each week at a time convenient for them. Each session will include completing practice activities and sharing information (e.g., offering advice and support to one another through the discussion forum). OTs will facilitate the discussions by responding to entries, asking questions, and providing encouragement to complete sessions. |
|
| 1-to-1, in-person or videoconference | Behavioral | Unlike the teleconference and internet courses, the number and length of sessions for the 1-to-1, in-person or videoconference course will vary over the 6-week period. The OT will cover all 6 topics, but the pace will be tailored to the participants' needs and preferences. Thus, although the topics are consistent, OTs are able to spend more time on topics that participants find pertinent to their situations. The participant and OT will be instructed to meet at least 3 times with at least 7 days between each session. |
|
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| BG001 | Internet | Internet Intervention arm Internet: The internet course is similar to the teleconference format. It will occur in a 6-week period and be group based; i.e., 8-12 participants will begin the intervention at the same time and interact with each other during the 6-week period. Participants will be given a username and a password to view a different session each week at a time convenient for them. Each session will include completing practice activities and sharing information (e.g., offering advice and support to one another through the discussion forum). OTs will facilitate the discussions by responding to entries, asking questions, and providing encouragement to complete sessions. |
| BG002 | One-to-One | One-to-One intervention arm One-to-one: Unlike the teleconference and internet courses, the number and length of sessions for the 1-to-1, in-person or videoconference course will vary over the 6-week period. The OT will cover all 6 topics, but the pace will be tailored to the participants' needs and preferences. Thus, although the topics are consistent, OTs are able to spend more time on topics that participants find pertinent to their situations. The participant and OT will be instructed to meet at least 3 times with at least 7 days between each session. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Fatigue Impact Scale | Mean | Standard Deviation | units on a scale |
|
| OG001 | Internet | Internet Intervention arm Internet: The internet course is similar to the teleconference format. It will occur in a 6-week period and be group based; i.e., 8-12 participants will begin the intervention at the same time and interact with each other during the 6-week period. Participants will be given a username and a password to view a different session each week at a time convenient for them. Each session will include completing practice activities and sharing information (e.g., offering advice and support to one another through the discussion forum). OTs will facilitate the discussions by responding to entries, asking questions, and providing encouragement to complete sessions. |
| OG002 | One-to-one | One-to-one intervention arm One-to-one, in-person or videoconference: Unlike the teleconference and internet courses, the number and length of sessions for the 1-to-1, in-person course will vary over the 6-week period. The OT will cover all 6 topics, but the pace will be tailored to the participants' needs and preferences. Thus, although the topics are consistent, OTs are able to spend more time on topics that participants find pertinent to their situations. The participant and OT will be instructed to meet at least 3 times with at least 7 days between each session. |
|
|
|
| Secondary | Change From Baseline in Health-related Quality of Life: Psychological Composite | Multiple Sclerosis Impact Scale (MSIS) was used to measure health-related quality of life. It consists of 29 self-report questions. The psychological composite score is calculated on a scale between 1 and 100. Higher scores indicate worse health-related quality of life. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 6 months |
|
|
|
|
| 0 |
| 196 |
| 0 |
| 196 |
| 0 |
| 196 |
| EG001 | Internet | Internet Intervention arm Internet: The internet course is similar to the teleconference format. It will occur in a 6-week period and be group based; i.e., 8-12 participants will begin the intervention at the same time and interact with each other during the 6-week period. Participants will be given a username and a password to view a different session each week at a time convenient for them. Each session will include completing practice activities and sharing information (e.g., offering advice and support to one another through the discussion forum). OTs will facilitate the discussions by responding to entries, asking questions, and providing encouragement to complete sessions. | 0 | 197 | 0 | 197 | 0 | 197 |
| EG002 | One-to-One | One-to-one intervention arm 1-to-1: Unlike the teleconference and internet courses, the number and length of sessions for the 1-to-1, in-person course will vary over the 6-week period. The OT will cover all 6 topics, but the pace will be tailored to the participants' needs and preferences. Thus, although the topics are consistent, OTs are able to spend more time on topics that participants find pertinent to their situations. The participant and OT will be instructed to meet at least 3 times with at least 7 days between each session. | 0 | 197 | 0 | 197 | 0 | 197 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004812 |
| Epidemiologic Methods |
| D008919 | Investigative Techniques |