Viewing Study NCT03584386



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Last Modification Date: 2024-10-26 @ 12:49 PM
Study NCT ID: NCT03584386
Status: COMPLETED
Last Update Posted: 2021-04-21
First Post: 2018-06-11

Brief Title: CAMS Relational Agent System CAMS-RAS for Suicide Prevention
Sponsor: Evidence-Based Practice Institute Seattle WA
Organization: Evidence-Based Practice Institute Seattle WA

Study Overview

Official Title: CAMS Relational Agent System CAMS-RAS for Suicide Prevention
Status: COMPLETED
Status Verified Date: 2021-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: V-CAMS
Brief Summary: This Phase II study is a continuation of the Phase I feasibility study where the investigators fully met and exceeded project aims to design build and test the usability and acceptability of an avatar-based system the Virtual-CAMS V-CAMS formerly called CAMS-RAS for use by suicidal ED patients and medical personnel responsible for their care Phase II includes a formative phase during which the investigators will continue conducting usability and acceptability tests of new features and a summative phase to conduct a clinical trial SBIR Phase II project aims include 1 Complete development of V-CAMS including readiness for electronic health record integration 2 Cultivate and utilize the advisory board so that V-CAMS is positioned to meet the needs of diverse healthcare systems and successful conduct of the proposed research 3 Conduct usabilityacceptability tests of new features with target end-users suicidal patients including those in the ED medical providers and key stakeholders ie administrators and 4 Conduct a randomized controlled trial RCT N90 of suicidal ED patients comparing V-CAMS n45 to Care-As-Usual CAU n45 Participants will be assessed at baseline while in the ED and again at 7 30 and 90 days The investigators predict that V-CAMS participants will report a significantly greater decrease in suicidal behaviors and EDhospital admissions as well as significantly greater increases in use of behavioral coping skills self-efficacy in coping with distress and perceived helpfulness of patients ED experience and satisfaction with the app This study however was paused due to COVID after February 2020 with a total of 31 participants recruited The study later resumed at one site however because of COVID there were fewer admissions for suicidal behavior to the ED only 7 participants were enrolled before the study ended recruitment in December 2020 V-CAMS is now known as Jaspr Health Jaspr A telehealth clinical trial will be conducted with suicidal outpatients to compare the Jaspr-At-Home companion mobile app JAH n30 and CAU in addition to crisis safety planning n30 Participants will be assessed at baseline 30- and 90-days after the initial session
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None