Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07488559
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:
NCT07488559
Study Brief:
Protocol Section:
NCT07488559