Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07071324

CF Wellness Program

Led by Johns Hopkins University · Updated on 2026-02-13

80

Participants Needed

3

Research Sites

125 weeks

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

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.

CONDITIONS

Official Title

CF Wellness Program

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Documented diagnosis of cystic fibrosis in medical records
  • Fatigue Severity Scale score greater than 4
  • Access to a smartphone, tablet, or computer with internet
  • Ability to understand, read, and speak English
  • Receives cystic fibrosis care at a participating CF Center
Not Eligible

You will not qualify if you...

  • Pulmonary exacerbation within 14 days before enrollment (as determined by physician, may include oral antibiotics, IV antibiotics, or hospitalization)
  • Pregnant or less than 6 months postpartum (self-reported)
  • Contraindications to light physical activity (as determined by treating physician, including pulmonary, cardiovascular, or musculoskeletal issues)
  • Participation in the CFWP Feasibility Study
  • Currently enrolled in another interventional 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

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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

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Research Team

K

Kristin Riekert, PhD

CONTACT

A

Annice Brown

CONTACT

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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