Trial Information
Current as of July 25, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is testing a new program called the Cystic Fibrosis Wellness Program (CFWP) to see if it helps people with cystic fibrosis (CF) feel less tired, sleep better, and be more active during the day. The study will compare this program to the usual care people with CF receive. Researchers want to find out if participants can stick with the program, complete the study assessments, and provide good-quality data from fitness trackers that monitor activity and sleep. This is an early study with about 80 participants to see if the program shows promise before doing larger studies.
Adults with CF who feel noticeably tired (scoring higher than 4 on a fatigue questionnaire) and have access to the internet through a smartphone, tablet, or computer may be eligible to join. Participants must receive care at certain CF centers and be able to understand English. People who recently had a lung infection, are pregnant or recently had a baby, or have health issues that make light exercise unsafe won’t be able to join. If you take part, you’ll be asked to complete coaching sessions over several weeks and wear a fitness tracker to monitor your activity and sleep. The study is not yet recruiting, but it aims to help improve quality of life for people living with CF by addressing fatigue and sleep problems.
Gender
ALL
Eligibility criteria
- 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 physician and may include pulmonary, cardiovascular, or musculoskeletal contraindications)
- • 4. Participated in the CFWP Feasibility Study
- • 5. Currently enrolled in another interventional trial
- • 6. Unavailable to complete coaching sessions within the study timeframe
About Johns Hopkins University
Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Denver, Colorado, United States
Patients applied
Trial Officials
Kristin Riekert, PhD
Principal Investigator
Johns Hopkins University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported