Actively Recruiting
CF Wellness Program: ORBIT Phase 2 Pilot Randomized Controlled Trial
Led by Johns Hopkins University · Updated on 2026-02-13
80
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
B
Boston Children's Hospital, Boston, MA, USA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the CF Wellness Program (CFWP), a behavioral intervention combining cognitive behavioral therapy (CBT) and physical activity, for adults with cystic fibrosis (CF) who experience fatigue and poor sleep. The study aims to compare CFWP to usual care in a pilot randomized control trial with 80 participants. The trial focuses on measuring adherence to the intervention, participant retention, and the quality of fitness tracker data. It also seeks to gather preliminary evidence on whether the CFWP improves fatigue, sleep, physical activity, and reduces sedentary behavior compared to usual care. Participants are randomly assigned either to the CFWP group or to usual care. Those in the CFWP group receive written materials and up to eight coaching sessions tailored to fatigue, physical activity, and mental well-being, delivered via web-based video chat or telephone. The sessions last approximately 45 to 60 minutes. The control group continues with their usual clinical care. The follow-up assessment occurs at 15 weeks after baseline. During the study, participants complete assessments at baseline and at week 15, including surveys on fatigue and sleep quality, as well as physical activity measured by fitness trackers and questionnaires. The study collects data on intervention adherence by tracking coaching session attendance and retention by completion of the week 15 assessment. Researchers will also evaluate the quality of daytime and nighttime fitness tracker data. This trial is sponsored by Johns Hopkins University and will run until June 2028.
CONDITIONS
Brief Title
CF Wellness Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Medical record documentation of cystic fibrosis diagnosis
- Score greater than 4 on the Fatigue Severity Scale
- Access to a smartphone, tablet, or computer with internet access
- Ability to understand, read, and speak English
- Receives cystic fibrosis care at a participating CF Center
You will not qualify if you...
- Pulmonary exacerbation within 14 days before enrollment as determined by a physician
- Pregnant or less than 6 months postpartum (self-reported)
- Contraindication to light physical activity as determined by the treating physician
- Participation in the CF Wellness Program Feasibility Study
- Currently enrolled in another interventional clinical trial
- Unavailable to complete coaching sessions within the study timeframe
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - Up to 15 weeks
Participants receive the CF Wellness Program, which includes written materials and up to 8 coaching sessions designed to improve fatigue, sleep, and physical activity. Sessions last approximately 45 to 60 minutes and are delivered by video chat or telephone.
Up to 8 coaching sessions conducted virtually
Duration - Assessment at Week 15
Participants complete a follow-up assessment to evaluate fatigue, sleep quality, and physical activity after the intervention period.
1 follow-up assessment visit (virtual or in-person)
Trial Site Locations
Total: 3 locations
1
National Jewish Health
Denver, Colorado, United States, 80206
Not Yet Recruiting
2
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Actively Recruiting
3
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
Research Team
K
Kristin Riekert, PhD
A
Annice Brown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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