Clinical trial NCT04809207: Acceptability, Feasibility and Preliminary Efficacy of CFWP to Treat Clinically Elevated Fatigue in Adults With CF
Official title: The CF Wellness Program to Treat Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Fatigue
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Cystic Fibrosis Foundation
First posted: 2021-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research is being done to learn more ways to treat non-respiratory symptoms in people with CF including fatigue, pain, mood, sleep problems and the use of a wellness program to treat them.

Detailed description: This study aims to test the acceptability, feasibility and preliminary efficacy of a tailored intervention known as the CF Wellness Program (CFWP) to treat clinically elevated fatigue in adults with CF. This is a pre-post pilot intervention study of the CF-Wellness Program. This study is needed because fatigue negatively affects health-related quality of life and has been identified by those with CF as a symptom that needs to be addressed. The study will include approximately 50 participants and the intervention will last approximately 13 weeks.

Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Documentation of CF diagnosis in the medical record
* If prescribed a modulator (i.e., ivacaftor, lumacaftor/ivacaftor, tezacaftor/ivacaftor, \& elexacaftor/tezacaftor/ivacaftor), have been on treatment for at least 4 weeks
* If prescribed medicine for psychiatric purpose, must be on treatment for at least 8 weeks
* Has 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
* Has a score of \>4 on the Fatigue Severity Scale
* Not likely to start and/or change modulator treatments during the intervention period

Exclusion Criteria:

* Receiving antibiotic treatment for a pulmonary exacerbation 14 days prior to the screening or expected to start within 14 days after screening visit
* Is pregnant or less than 6 months postpartum (self-reported)
* Is currently participating in another interventional trial
* Contraindication for aerobic exercise (determined by treating physician including cardiovascular, pulmonary and/or musculoskeletal contraindications)
* Forced Expiratory Volume in 1 second percent predicted (FEV1pp) is \<25% within last year
* Planning to transfer care to a non-participating CF Center before the post-intervention visit could be completed
* Will not be available to complete CF-Wellness sessions in a timely fashion (e.g., will be on extended travel)
* Has already participated in the CF Wellness Program

Primary outcomes:
measure: Proportion enrolled in the CF Wellness Program (CFWP)
timeFrame: Day 0
measure: Proportion of cognitive behavioral therapy (CBT) sessions completed
timeFrame: At approximately 13 weeks post intervention
measure: Proportion of weeks participant synced the fitness tracker watch to the Smartphone app
timeFrame: At approximately 13 weeks post intervention
Secondary outcomes:
measure: Feasibility of the CF Wellness Program as assessed by the Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients
timeFrame: At approximately 13 weeks post intervention
measure: Acceptability of the CF Wellness Program as assessed by the Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients
timeFrame: At approximately 13 weeks post intervention
measure: Qualitative interview as assessed by thematic analysis
timeFrame: At approximately 13 weeks post intervention
measure: Mean change in fatigue as assessed by the Functional Assessment of Chronic Illness-Fatigue ( FACIT-F) Scale
timeFrame: Day 1 to approximately 13 weeks post intervention
measure: Change in exercise capacity as assessed by the 1 Minute Sit to Stand Test (1MSTST) test and Fitness tracker watch
timeFrame: Day 1 to approximately 13 weeks post intervention
measure: Change self-reported sleep disturbance as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Day 1 to approximately 13 weeks post intervention
measure: Change in self-reported pain as assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity scale
timeFrame: Day 1 to approximately 13 weeks post intervention
measure: Change in self-reported depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)
timeFrame: Day 1 to approximately 13 weeks post intervention
measure: Change in self-reported anxiety as assessed by the General Anxiety Disorder - 7 (GAD7) scale
timeFrame: Day 1 to approximately 13 weeks post intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Johns Hopkins University
name: Kristin Riekert, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Chris Goss, MD
role: PRINCIPAL_INVESTIGATOR
References: