BridgeMD
New treatment option for Cystic Fibrosis (CF)
Official title CF Wellness Program
ClinicalTrials.gov ID: NCT07071324
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- Participated in the CFWP Feasibility Study
- Currently enrolled in another treatment trial
- Unavailable to complete coaching sessions within the study timeframe
See the full eligibility criteria
- ≥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
- 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 treatment trial
- Unavailable to complete coaching sessions within the study timeframe
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.