CF Wellness Program: ORBIT Phase 2 Pilot RCT
Johns Hopkins University
Summary
This study is a pilot randomized control trial (RCT; N=80) comparing the Cystic Fibrosis Wellness Program (CFWP) to usual care (UC) to evaluate (1) Intervention Adherence (completion of the CFWP Coaching Sessions) (2) Study Retention (completion of the Week 15 assessment) and (3) Data Quality (valid daytime and nighttime fitness tracker data). A secondary aim is to gather preliminary data to determine if the CFWP has a clinically significant signal over usual care to improve fatigue, sleep, and physical activity (PA) and reduce sedentary behavior.
Description
Highly effective modulator therapy (HEMT) has improved lung health for many adults with cystic fibrosis (CF), but does not appear to have translated into improved fatigue, sleep, or physical activity (PA). A study of 236 adults with CF (86% of whom were taking HEMT) found that 43% experienced elevated fatigue, while 63% reported poor sleep quality. Fatigue, poor sleep, and less PA are associated with worse physical and mental health outcomes, such as respiratory symptoms, lung function, depression, and anxiety. Cognitive behavioral therapy (CBT) is a well-established treatment for insomnia, pa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. ≥18 years old 2. Documentation of CF diagnosis in the medical record 3. Score of \>4 on the Fatigue Severity Scale 4. Access to a smartphone, tablet, and/or computer with access to internet 5. Ability to understand/read/speak English 6. Receives CF care at a participating CF Center Exclusion Criteria: 1. Pulmonary exacerbation (physician determined and may include oral antibiotics, IV antibiotics, hospitalization) ±14 days of enrollment 2. Pregnant or \<6 months post-partum (self-reported) 3. Contraindication to light physical activity (as determined by the treating p…
Interventions
- BehavioralCF Wellness Program
Intervention modules are 1) Introduction \& Fatigue Explained, 2) Finding Balance between Activity \& Rest, 3) Physical Activity, Self-Review \& Planning, 4) Improving Your Sleep, 5) Managing Emotions, 6) Changing Less Helpful Thoughts, 7) Learning to Relax \& Manage Stress, and 8) Accessing Social Support and Preparing for the Future.
Locations (3)
- National Jewish HealthDenver, Colorado
- Johns Hopkins UniversityBaltimore, Maryland
- Boston Children's HospitalBoston, Massachusetts