Acceptability, Feasibility and Preliminary Efficacy of CFWP to Treat Clinically Elevated Fatigue in Adults With CF

Johns Hopkins University

Status

Completed

Conditions

Cystic Fibrosis

Fatigue

Treatments

Other: CF Wellness Program Sessions

Study type

Interventional

Funder types

Other

Identifiers

NCT04809207

IRB00202780

Details and patient eligibility

About

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.

Full 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 CF. This is a pre-post pilot intervention study of the CF-Wellness Program. This study is needed because fatigue negatively affects health-related quality of life and has been identified by those with CF as a symptom that needs to be addressed. The study will include approximately 50 participants and the intervention will last approximately 13 weeks.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥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 criteria

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