Status:
COMPLETED
Acceptability, Feasibility and Preliminary Efficacy of CFWP to Treat Clinically Elevated Fatigue in Adults With CF
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
University of Washington
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Fatigue
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This research is being done to learn more ways to treat non-respiratory symptoms in people with CF including fatigue, pain, mood, sleep problems and the use of a wellness program to treat them.
Detailed Description
This study aims to test the acceptability, feasibility and preliminary efficacy of a tailored intervention known as the CF Wellness Program (CFWP) to treat clinically elevated fatigue in adults with C...
Eligibility Criteria
Inclusion
- ≥18 years old
- Documentation of CF diagnosis in the medical record
- If prescribed a modulator (i.e., ivacaftor, lumacaftor/ivacaftor, tezacaftor/ivacaftor, \& elexacaftor/tezacaftor/ivacaftor), have been on treatment for at least 4 weeks
- If prescribed medicine for psychiatric purpose, must be on treatment for at least 8 weeks
- Has access to a smartphone, tablet, and/or computer with access to internet
- Ability to understand/read/speak English
- Receives CF care at a participating CF Center
- Has a score of \>4 on the Fatigue Severity Scale
- Not likely to start and/or change modulator treatments during the intervention period
Exclusion
- Receiving antibiotic treatment for a pulmonary exacerbation 14 days prior to the screening or expected to start within 14 days after screening visit
- Is pregnant or less than 6 months postpartum (self-reported)
- Is currently participating in another interventional trial
- Contraindication for aerobic exercise (determined by treating physician including cardiovascular, pulmonary and/or musculoskeletal contraindications)
- Forced Expiratory Volume in 1 second percent predicted (FEV1pp) is \<25% within last year
- Planning to transfer care to a non-participating CF Center before the post-intervention visit could be completed
- Will not be available to complete CF-Wellness sessions in a timely fashion (e.g., will be on extended travel)
- Has already participated in the CF Wellness Program
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04809207
Start Date
May 1 2021
End Date
July 25 2023
Last Update
August 28 2023
Active Locations (2)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21224
2
University of Washington Medical Center
Seattle, Washington, United States, 356522