Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401967
Status:
WITHDRAWN
Last Update Posted:
2024-07-01
First Post:
2024-05-02
Brief Title:
Study of a Smartphone-Based Alcohol Reduction Program
Sponsor:
Pivot Health Technologies Inc
Organization:
Pivot Health Technologies Inc
Study Overview
Official Title:
Feasibility Acceptability and Preliminary Outcomes of a Smartphone-Based Program for Reduction in Alcohol Consumption
Status:
WITHDRAWN
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change in research priorities
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective open label single center clinical study enrolling up to 100 adult participants to evaluate the feasibility acceptability and preliminary outcomes of the Pivot Clear smartphone-based alcohol reduction program
Detailed Description:
This is a prospective open label single center clinical study conducted with institutional review board IRB approval enrolling up to 100 adult participants who report at-risk alcohol consumption behavior and would like to reduce or eliminate alcohol consumption The study will be performed remotely on an ambulatory basis Participants will be asked to set up and use the Pivot Clear program The program includes an app personal breathalyzer and short message service SMS text-based coaching with an alcohol reduction specialist The study duration is 52 weeks While participants will have access to the program for 52 weeks it is expected that for most participants most active participation in the program will be complete by 12 weeks The primary reporting time point will be 12 weeks with expected passive longer-term follow-up outcomes collected at 26 weeks and 52 weeks Participants will receive online questionnaires at intervals throughout the study baseline weekly for the first 12 weeks at 26 weeks and at 52 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None