Cystic Fibrosis Clinical Trials

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CF Wellness Program: ORBIT Phase 2 Pilot RCT

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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

• Ability to understand/read/speak English

• Receives CF care at a participating CF Center

Locations
United States
Colorado
National Jewish Health
NOT_YET_RECRUITING
Denver
Massachusetts
Boston Children's Hospital
NOT_YET_RECRUITING
Boston
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Contact Information
Primary
Kristin Riekert, PhD
kriekert@jhmi.edu
4105507755
Backup
Annice Brown
abrow272@jh.edu
Time Frame
Start Date: 2026-02-03
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 80
Treatments
Experimental: Treatment Group
Adults With Cystic Fibrosis (AWCF) randomized to the intervention will receive the CFWP written materials and be offered up to 8 coaching sessions tailored to fatigue, physical activity, and mental well-being. The sessions will last approximately 45 - 60 minutes and be delivered either by web-based video chat (e.g., Zoom) or by telephone.
No_intervention: Usual Care
Usual clinical care
Related Therapeutic Areas
Sponsors
Collaborators: Boston Children's Hospital, Boston, MA, USA, Cystic Fibrosis Foundation, National Jewish Health
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov

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