Fatigue Management Programs for People With MS

NCT03550170 | Completed Results

• 1 other identifier: MS-1610-37015
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Fatigue; Wellness; Multiple Sclerosis; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change From Baseline in Health-related Quality of Life: Psychological Composite

  Change from baseline to 6 months

Study Arms (3)

Teleconference

ACTIVE COMPARATOR

Teleconference Intervention arm

Behavioral: Teleconference

Internet

ACTIVE COMPARATOR

Internet Intervention arm

Behavioral: Internet

I-to-1, in-person or videoconference

ACTIVE COMPARATOR

1-to-1, in-person or videoconference intervention arm

Behavioral: 1-to-1, in-person or videoconference

Interventions

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.

Teleconference

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.

Internet

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.

I-to-1, in-person or videoconference

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-report diagnosis of MS
• Age ≥ 18 years
• Fatigue Severity Scale score ≥ 4
• Ability to speak English

You may not qualify if:

• Individual must be capable of providing consent (Assessed with questionnaire)
• Unable to access the internet or unable to travel to in-person sessions

Sponsors & Collaborators

• Case Western Reserve University: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of Illinois at Chicago: collaborator
• University of Minnesota: collaborator
• Queen's University, Kingston, Ontario: collaborator
• Dalhousie University: collaborator
• The Cleveland Clinic: collaborator

Study Sites (3)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 32801193 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Patient Portals

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Records, Personal; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Results Point of Contact

• Title: Dr. Matthew Plow
• Organization: Case Western Reserve University

map208@case.edu

216-368-8969

Study Officials

• Matthew Plow, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 8, 2018
• Study Start: March 1, 2019
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: February 4, 2025
• Results First Posted: September 23, 2024

Record last verified: 2025-01

Locations

US (3)