Search / Trial NCT06616857

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

Launched by NEMOURS CHILDREN'S CLINIC · Sep 25, 2024

Trial Information

Current as of December 21, 2024

Not yet recruiting

Keywords

Physical Activity

ClinConnect Summary

The goal of this study is to conduct a 6-month delayed treatment pilot Trial with adolescents and young adults (AYA) ages 13-25 with Cystic Fibrosis (CF) or a CF related disorder) to establish feasibility and obtain data necessary to inform a Phase III efficacy trial. AYAs 18 years-old and caregivers of AYAs 13-17 years-old will complete the informed consent process. AYAs 13-17 years-old will be asked to assent to participate in the study. After completion of the baseline study measures and return of actigraphy monitors, staff will notify AYAs of their randomized assignment. AYAs receiving ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. 13-25 years old
  • 2. Has a verified CF diagnosis or CF-related disorder
  • 3. Medically stable (i.e., FEV1\>30%, not experiencing a CF-related exacerbation)
  • 4. Speaks and reads English
  • Exclusion Criteria:
  • 1. Have a comorbidity limiting PA participation (e.g., neurological condition)
  • 2. Have a significant cognitive impairment that interferes with study completion
  • 3. Have any oxygen, CPAP or BiPAP requirement

About Nemours Children's Clinic

Nemours Children's Clinic is a leading pediatric healthcare organization dedicated to enhancing the health and well-being of children through innovative clinical care, research, and education. As a prominent clinical trial sponsor, Nemours is committed to advancing pediatric medicine by conducting rigorous clinical trials that explore new treatments and therapies. The clinic's multidisciplinary team of experts collaborates closely with families and community partners to ensure that research initiatives are aligned with the unique needs of children. With a focus on safety, efficacy, and ethical standards, Nemours Children's Clinic aims to foster breakthroughs that will improve health outcomes for children and adolescents.

Locations

Jacksonville, Florida, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0