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| Name | Class |
|---|---|
| Boston Children's Hospital, Boston, MA, USA | OTHER |
| National Jewish Health | OTHER |
| Cystic Fibrosis Foundation | OTHER |
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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.
Highly effective modulator therapy (HEMT) has improved lung health for many adults with cystic fibrosis (CF), but does not appear to have translated into improved fatigue, sleep, or physical activity (PA). A study of 236 adults with CF (86% of whom were taking HEMT) found that 43% experienced elevated fatigue, while 63% reported poor sleep quality. Fatigue, poor sleep, and less PA are associated with worse physical and mental health outcomes, such as respiratory symptoms, lung function, depression, and anxiety. Cognitive behavioral therapy (CBT) is a well-established treatment for insomnia, pain, and mood disorders, with emerging data that it helps with fatigue. Similarly, increasing PA reduces fatigue and improves sleep. There is no research evaluating whether CBT or PA improves fatigue or sleep for adults with CF. Investigators developed a CBT+PA intervention for adults with CF and fatigue, known as the CF Wellness Program (CFWP), which includes written materials and up to eight virtual sessions with a Coach. The goal of the proposed pilot study is twofold. First, to evaluate session attendance and determine if research-quality fitness tracker data can be collected to objectively measure sleep and PA. Second, investigators will gather preliminary data to determine if the CFWP has a clinically significant signal over usual care to improve fatigue, sleep, and PA and reduce sedentary behavior. This study will enroll 80 adults with CF and fatigue. After completing the baseline assessment, half the participants will be randomized to receive the CFWP and half will not. The follow-up assessment will be collected at Week 15.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual Care | No Intervention | Usual clinical care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristin Riekert, PhD | Contact | 4105507755 | kriekert@jhmi.edu | |
| Annice Brown | Contact | abrow272@jh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kristin Riekert, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Not yet recruiting | Denver | Colorado | 80206 | United States |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D005221 | Fatigue |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D009043 | Motor Activity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Baseline, Week 15 |
| 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. | Baseline, 15 weeks |
| 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. | Baseline, 15 weeks |
| 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. | Baseline, 15 weeks |
| Participant physical activity levels assessed by fitness tracker data | Sedentary behavior will be defined as averaging <5000 steps/day, physically active will be defined as averaging >7500 steps/day, and consistent physical activity will be defined as a greater reduction in the daily step count standard deviation at baseline compared to the week 15 assessment. | Baseline, Week 15 |
| Physical activity (PA) as assessed the International Physical Activity Questionnaire (IPAQ) - Short Form. | The IPAQ is a 7-item self-report on physical activity. Minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080 | Baseline, Week 15 |
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21224 | United States |
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| Boston Children's Hospital | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
|
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D001519 | Behavior |