CF Wellness Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
Qualifiers
≥18 years old
Documentation of CF diagnosis in the medical record
Score of >4 on the Fatigue Severity Scale
Access to a smartphone, tablet, and/or computer with access to internet
Disqualifiers
Pulmonary exacerbation (physician determined and may include oral antibiotics, IV antibiotics, hospitalization) ±14 days of enrollment
Pregnant or <6 months post-partum (self-reported)
Contraindication to light physical activity (as determined by the treating physician and may include pulmonary, cardiovascular, or musculoskeletal contraindications)
Participated in the CFWP Feasibility Study
Trial design
Treatments tested in this trial
- CF Wellness Program
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
Boston Children's Hospital, Boston, MA, USA
Collaborator
National Jewish Health
Collaborator
Cystic Fibrosis Foundation
Collaborator
Source ClinicalTrials.gov