Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616857
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NUDGE
Brief Summary:
The goal of this clinical trial is to help adolescents and young adults between the ages of 13-25 with Cystic Fibrosis CF medically stable able to speak and read English and are not experiencing a CF - related exacerbation who are already active to remain or gradually encourage them to increase their levels of physical activity
Participants will be asked to utilize a smartphone program called NUDGE that we have developed NUDGE is a chatbot with evidence-based features known to help teens make progress toward health goal
Set and review goals
Self-monitor progress
Provide feedback on goal attainment
Revise future goals
Participants will be asked to utilize a smartphone program called NUDGE that we have developed NUDGE is a chatbot with evidence-based features known to help teens make progress toward health goal
Set and review goals
Self-monitor progress
Provide feedback on goal attainment
Revise future goals
Detailed Description:
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 NUDGE will then begin receiving intervention content for 6 months AYAs randomized to control will receive NUDGE at the conclusion of the Month 3 study visit Study visits will occur at Months 0 3 and 6 with staff masked to treatment assignment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None