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Behavioral Intervention
Mobile Health Platform for Cystic Fibrosis (NUDGE Trial)
N/A
Waitlist Available
Research Sponsored by Nemours Children's Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Medically stable (FEV1>30%, not experiencing a CF-related exacerbation)
13-25 years old
Must not have
Have a significant cognitive impairment that interferes with study completion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3-month, and 6-month
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to help teenagers and young adults aged 13-25 with Cystic Fibrosis (CF) to increase their physical activity levels. Participants will use a smartphone program called NUDGE,
Who is the study for?
This trial is for adolescents and young adults aged 13-25 with Cystic Fibrosis who are medically stable, can communicate in English, and aren't currently having a CF-related health crisis. It aims to help those already active stay that way or encourage less active individuals to increase their physical activity.
What is being tested?
The intervention being tested is a mobile app called NUDGE designed for smartphones. It's a chatbot that helps set fitness goals, monitor progress, give feedback on achievements, and adjust future objectives based on evidence-based strategies.
What are the potential side effects?
Since the intervention involves using an app for promoting physical activity rather than medication or medical procedures, there are no direct side effects associated with it. However, participants should engage in exercise appropriate for their condition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung function is stable and I'm not having a cystic fibrosis flare-up.
Select...
I am between 13 and 25 years old.
Select...
I have been diagnosed with cystic fibrosis or a related disorder.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have cognitive issues that would stop me from completing the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3-month, and 6-month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3-month, and 6-month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability
Engagement
Recruitment
+1 moreSecondary study objectives
Actigraphy
CF Quality of Life
Lung Functioning
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NUDGEExperimental Treatment1 Intervention
Group II: EducationActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Nemours Children's ClinicLead Sponsor
127 Previous Clinical Trials
18,393 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
6 Patients Enrolled for Cystic Fibrosis
Cystic Fibrosis FoundationOTHER
197 Previous Clinical Trials
37,540 Total Patients Enrolled
190 Trials studying Cystic Fibrosis
34,643 Patients Enrolled for Cystic Fibrosis