Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— CAFE-MS  

Official title:

Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441617
• Other study ID #: ACP-CAFE-MS-001
• Secondary ID: CDMRP- MS220136
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: September 14, 2027

Study information

• Verified date: May 2024
• Source: Accelerated Cure Project for Multiple Sclerosis
• Contact: Grace Okafor
• Phone: 781-487-0008
• Email: cafe-ms[@]iconquerms.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

CAFE-MS will assess the effectiveness of two online programs for fatigue in multiple sclerosis (MS). Although they differ, both of these online programs contain information about MS and fatigue intended to help people with MS understand and manage their fatigue. This large-scale, decentralized clinical trial is projected to enroll 2,000 people with MS. The collaboration between iConquerMS and 5 Veterans Affairs (VA) sites in the MS Centers of Excellence is designed to ensure sufficient representation of people with MS from populations traditionally under-represented in MS clinical trials. The study is a 3-arm, randomized controlled clinical trial with study participation lasting 1 year. Two of the trial arms will include one of two online programs for managing fatigue in MS added to the trial participants' usual MS treatment, and the third arm will include usual MS treatment alone. The online program phase of the trial lasts for 6 months after randomization followed by a final study visit at 12 months. Participants in the usual MS treatment alone arm for the first 6 months will have an opportunity to choose one of the online programs for the final 6 months of the trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: September 14, 2027
• Est. primary completion date: February 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Informed consent by person with MS
• Living in the US
• Age = 22
• Confirmed diagnosis of MS by a physician, who is a neurologist or has access to a neurologist's statement of diagnosis
• Fatigue Severity Scale score at or above eligibility threshold
• Fluent in English
• Willingness to engage in self-administration of an online intervention for 24 weeks and complete follow-up assessments
• Access to the internet and e-mail with a compatible device (smartphone, computer, or tablet)
• No MS relapse / no steroid treatment in the 4 weeks prior to answering the screening questionnaire (self-reported)
• No disease-modifying therapeutic (DMT) started in the 4 weeks prior to answering the screening questionnaire (self-reported)

Exclusion Criteria:

• Unwilling or unable to consent
• Refusal to saving, processing and forwarding of pseudonymized data
• Concurrent participation in another interventional trial

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Online Therapy for Fatigue
An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Accelerated Cure Project for Multiple Sclerosis	Charite University, Berlin, Germany, Congressionally Directed Medical Research Programs, United States Department of Defense, University Medical Center Goettingen, US Department of Veterans Affairs

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Acceptability	The Treatment Acceptability questionnaire consists of seven 5-point Likert items covering affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy.	Day 180
Primary	Chalder Fatigue Scale	The scale contains 11 items covering physical fatigue (items 1-7) and mental fatigue (items 8-11).	Day 180
Secondary	PROMIS FatigueMS-8a	The PROMIS FatigueMS-8a questionnaire has eight 5-point Likert scale items on different aspects of fatigue.	Day 180
Secondary	PROMIS MS Health	PROMIS MS Health has 14 domains, each comprising four 5-point Likert scale items, covering mobility limitations, spasticity, reduced hand and arm function, fatigue, pain, numbness, cognition issues, sleep disturbances, bowel and bladder dysfunction, vision problems, dizziness and vertigo, sexual dysfunction, mood and emotional changes plus a single 5-point Likert scale item for overall health.	Day 180
Secondary	SymptoMScreen	SymptoMScreen has twelve 7-point Likert scale items covering how each of the following MS symptoms affects everyday life activities: walking, hand function, spasticity, pain, sensory function, bladder control, fatigue, vision, dizziness, cognitive function, depression and anxiety.	Day 180
Secondary	Frenchay Activities Index	The Frenchay Activities Index (FAI) is a measure of instrumental activities of daily living (IADL) for use with patients with neurological disorders. The FAI assesses a broad range of activities associated with everyday life that the patient has participated in within the recent past, broken into 3 domains: domestic chores, leisure/work, and outdoor activities.	Day 180