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
This trial does not accept healthy volunteersQualifiers
≥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
Design model
Parallel
Treatments tested in this trial
CF Wellness Program
BehavioralIntervention 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 groups
80 Participants
are divided into 2 treatment groupsGroup A: Treatment GroupExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 15 weeks2
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.
Time frame
Week 153
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.
Time frame
Baseline, Week 15Secondary outcomes
1
Fatigue as assessed by the Functional Assessment of Chronic Illness-Fatigue (FACIT-F)
The number of CFWP participants reporting clinically improved fatigue compared to UC participants at the week 15 assessment. The FACIT-F is a 14-question instrument used to assess self-reported fatigue. Scores range from 0-52, with a score of \<34 indicating clinically significant fatigue. Lower scores indicate higher fatigue. Clinically improved fatigue is defined as a ≥4 points increase in the FACIT-F or no longer having fatigue (FACIT-F ≥34).
Time frame
Baseline, Week 152
Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item questionnaire that measures an individual's quality of sleep over the last month. Scores range from 0 to 21, with a score \>5 indicative of poor sleep quality.
Time frame
Baseline, 15 weeks3
Sleep Quality as assessed by the Insomnia Severity Index (ISI)
The ISI is a 7-item scale measuring the impact of insomnia in the past month. Total score ranging from 0 to 28, scores are categorized to indicate the severity of insomnia, ranging from no clinically significant insomnia (0-7) to severe insomnia (22-28). Higher score more severe insomnia.
Time frame
Baseline, 15 weeks4
Sleep patterns as assessed by the Consensus Sleep Diary - Core (CSD-C).
The CSD-C is a 9-item self-reported diary of sleep activity to determine patterns such as good sleeper or insomnia.
Time frame
Baseline, 15 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Boston Children's Hospital, Boston, MA, USA
Collaborator
National Jewish Health
Collaborator
Cystic Fibrosis Foundation
Collaborator
Source ClinicalTrials.gov