CF Wellness Program

NCT07071324 | Recruiting DMC

• 1 other identifier: IRB00496586
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cystic Fibrosis (CF); Fatigue; Sleep Quality; Insomnia

Keywords

Cystic Fibrosis (CF); Fatigue; Sleep Quality; Physical Activity; Insomnia; Cognitive Behavioral Therapy; Sedentary

Outcome Measures

Primary Outcomes (3)

• Intervention Adherence as assessed by the number of CFWP participants

  The number of participants randomized to receive the CFWP who complete all 8 coaching sessions.

  Up to 15 weeks

• Participant Retention as assessed by the number of participants completing the week 15 assessment survey

  The number of participants across both study groups who complete the week 15 assessment survey.

  Week 15

• Fitness Tracker Data Quality as assessed by the number of participants who have valid activity and sleep data.

  The number of participants who have valid sleep and activity data at the baseline and week 15 assessment. Valid physical and sleep activity was defined as \>10 hours of collected data across 4 days, including 1 weekend day and overnight.

  Baseline, Week 15

Secondary Outcomes (6)

• Fatigue as assessed by the Functional Assessment of Chronic Illness-Fatigue (FACIT-F)

  Baseline, Week 15

• Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)

  Baseline, 15 weeks

• Sleep Quality as assessed by the Insomnia Severity Index (ISI)

  Baseline, 15 weeks

• Sleep patterns as assessed by the Consensus Sleep Diary - Core (CSD-C).

  Baseline, 15 weeks

• Participant physical activity levels assessed by fitness tracker data

  Baseline, Week 15

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Behavioral: CF Wellness Program

Usual Care

NO INTERVENTION

Usual clinical care

Interventions

CF Wellness Program BEHAVIORAL

Intervention modules are 1) Introduction \& Fatigue Explained, 2) Finding Balance between Activity \& Rest, 3) Physical Activity, Self-Review \& Planning, 4) Improving Your Sleep, 5) Managing Emotions, 6) Changing Less Helpful Thoughts, 7) Learning to Relax \& Manage Stress, and 8) Accessing Social Support and Preparing for the Future.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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
• Currently enrolled in another interventional trial
• Unavailable to complete coaching sessions within the study timeframe

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Jewish Health: collaborator
• Cystic Fibrosis Foundation: collaborator
• Boston Children's Hospital, Boston, MA, USA: collaborator

Study Sites (3)

National Jewish Health

Denver, Colorado, 80206, United States

NOT YET RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21224, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis; Fatigue; Sleep Initiation and Maintenance Disorders; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior

Study Officials

• Kristin Riekert, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Riekert, PhD

CONTACT

4105507755; kriekert@jhmi.edu

Annice Brown

CONTACT

abrow272@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: February 3, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (3)