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Online Fatigue Management for Scleroderma (FAME-ISS Trial)
N/A
Waitlist Available
Led By Janet L Poole, PhD
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of systemic scleroderma
18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
FAME-ISS Trial Summary
This trial is testing whether an online fatigue management program can help reduce fatigue, pain, and increase confidence in managing fatigue and daily activities. It involves completing surveys before and after the intervention, and attending and participating in 1.5 hour weekly videoconference meetings for 6 weeks.
Who is the study for?
This trial is for adults in the U.S. with systemic scleroderma who feel very tired and have internet access to join weekly online meetings. They should speak English and be willing to attend a 1.5-hour virtual session each week for six weeks.Check my eligibility
What is being tested?
Researchers are testing an online program designed to help people with scleroderma manage their fatigue better. Participants will complete questionnaires and take part in videoconference sessions once a week for six weeks.See study design
What are the potential side effects?
Since this is an educational intervention, there are no direct medical side effects expected from participating in the online fatigue management program.
FAME-ISS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with systemic scleroderma.
Select...
I am 18 years old or older.
FAME-ISS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
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 Modified Fatigue Impact Scale at 6 weeks
Change from baseline Multidimensional Assessment of Fatigue at 6 weeks
Other outcome measures
Change from baseline Hospital Anxiety and Depression Scale at 6 weeks
Change from baseline PROMIS Self-Efficacy for Managing Symptoms at 6 weeks
Change from baseline Self-Efficacy for Performing Energy Conservation Strategies Assessment at 6 weeks
+1 moreFAME-ISS Trial Design
1Treatment groups
Experimental Treatment
Group I: Fatigue interventionExperimental Treatment1 Intervention
the Fatigue intervention is a 6 week intervention delivered using video teleconferencing
Find a Location
Who is running the clinical trial?
University of California, San DiegoOTHER
1,120 Previous Clinical Trials
1,521,395 Total Patients Enrolled
University of New MexicoLead Sponsor
372 Previous Clinical Trials
3,528,777 Total Patients Enrolled
Janet L Poole, PhDPrincipal InvestigatorUniversity of New Mexico
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with systemic scleroderma.I experience significant fatigue.I am 18 years old or older.I am willing and able to follow the study plan and attend all required appointments.I cannot communicate in English.You have a score of less than 12 on the tiredness questions.I can attend a 1.5 hour online meeting weekly for 6 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Fatigue intervention
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this study still offer opportunities to get involved?
"Per the information on clinicaltrials.gov, this experimental trial is no longer recruiting participants. It was initially posted in May of 2020 and had its last update two years later. That being said, there are still 81 other studies actively seeking applicants at present time."
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