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Behavioral Intervention
Fatigue Management Programs for Multiple Sclerosis
N/A
Waitlist Available
Led By Matthew Plow, PhD
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self-report diagnosis of MS
Age ≥ 18 years
Must not have
Unable to access the internet or unable to travel to in-person sessions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each patient will be given the assessments at 4 points during the study, at baseline, 8 weeks, 3 months, and 6 months
Awards & highlights
Summary
This trial is comparing 3 ways of delivering a course on reducing fatigue for people with MS. The goal is to see if the cheaper and easier versions are just as good as the in-person version.
Who is the study for?
This trial is for adults over 18 with multiple sclerosis (MS) who feel very tired and can speak English. They must be able to give consent, have internet access for online sessions or travel ability for in-person sessions.Check my eligibility
What is being tested?
The study compares three ways of delivering a fatigue management course: via the internet, teleconference, and one-on-one in person. It aims to see if the first two methods are just as good as personal meetings at reducing MS-related fatigue and improving life quality.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like educational courses delivered through various communication methods, there are no direct medical side effects associated with drugs or procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple sclerosis.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot access the internet or travel for in-person sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ each patient will be given the assessments at 4 points during the study, at baseline, 8 weeks, 3 months, and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~each patient will be given the assessments at 4 points during the study, at baseline, 8 weeks, 3 months, and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in fatigue levels
Secondary outcome measures
Change from Baseline in quality of life will be assessed
Trial Design
3Treatment groups
Active Control
Group I: TeleconferenceActive Control1 Intervention
Teleconference Intervention arm
Group II: InternetActive Control1 Intervention
Internet Intervention arm
Group III: I-to-1, in-personActive Control1 Intervention
1-to-1, in-person intervention arm
Find a Location
Who is running the clinical trial?
The Cleveland ClinicOTHER
1,037 Previous Clinical Trials
1,366,429 Total Patients Enrolled
19 Trials studying Multiple Sclerosis
3,566 Patients Enrolled for Multiple Sclerosis
Queen's University, Kingston, OntarioOTHER
7 Previous Clinical Trials
82,830 Total Patients Enrolled
Case Western Reserve UniversityLead Sponsor
300 Previous Clinical Trials
246,029 Total Patients Enrolled
5 Trials studying Multiple Sclerosis
501 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to understand and agree to the study's requirements.I cannot access the internet or travel for in-person sessions.You have severe tiredness with a score of 4 or higher on the Fatigue Severity Scale.I have been diagnosed with multiple sclerosis.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Teleconference
- Group 2: Internet
- Group 3: I-to-1, in-person
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT03550170 — N/A
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