CF Wellness Program

Официальное название

CF Wellness Program: ORBIT Phase 2 Pilot RCT

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое CF Wellness Program
  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.

Первичные конечные точки

• Intervention Adherence as assessed by the number of CFWP participants [Срок оценки: Up to 15 weeks]
• Participant Retention as assessed by the number of participants completing the week 15 assessment survey [Срок оценки: Week 15]
• Fitness Tracker Data Quality as assessed by the number of participants who have valid activity and sleep data. [Срок оценки: Baseline, Week 15]

Вторичные конечные точки (6)

• Fatigue as assessed by the Functional Assessment of Chronic Illness-Fatigue (FACIT-F) [Срок оценки: Baseline, Week 15]
• Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline, 15 weeks]
• Sleep Quality as assessed by the Insomnia Severity Index (ISI) [Срок оценки: Baseline, 15 weeks]
• Sleep patterns as assessed by the Consensus Sleep Diary - Core (CSD-C). [Срок оценки: Baseline, 15 weeks]
• Participant physical activity levels assessed by fitness tracker data [Срок оценки: Baseline, Week 15]
• Physical activity (PA) as assessed the International Physical Activity Questionnaire (IPAQ) - Short Form. [Срок оценки: Baseline, Week 15]

Критерии участия

Критерии включения

• ≥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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• National Jewish Health — Denver
• Johns Hopkins University — Baltimore
• Boston Children's Hospital — Boston

Идентификаторы

NCT: NCT07071324 · IRB00496586

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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