Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 4:21 AM
Study NCT ID:
NCT07488559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study 2: Social Engage Coaching R33 Phase
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
ENGAGE COACHING PROJECT R33
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
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:
None
Brief Summary:
The purpose of this study is to test whether an individual coaching program helps adults age 60 and older feel more connected to other people in ways that matter to them.
Detailed Description:
The R33 phase is an RCT (S-ENG+eCAU vs. eCAU only; n=120) with follow-up at 8- and 16 weeks to test target engagement and clinical impact. 10 days of ecological momentary assessment (EMA) will be completed at all assessment points. Participants are 120 adults age 60 and older who report clinically significant loneliness and have access to social activities outside the home. EMA will comprehensively assess indices of social connection. Subjects will complete EMA daily following 3 personally-selected times for prompts (to enhance recall and ease of completion of assessments) for 10-days prior to starting study interventions, beginning the day after the baseline visit. Each EMA instance takes approximately 2-5 minutes to complete. Subjects who successfully complete the smartphone assessment protocol at baseline will be randomly assigned to coaching or waitlist control. Study conditions are Engage Coaching (10 individual coaching sessions) over (up to) 4 month or waitlist control (assessments only for 4 months and then coaching is offered). The follow-up assessments include baseline measures and EMA.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R33MH129476-03 | NIH | None | https://reporter.nih.gov/quic… | View |