CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 186 enrolled
Drug / intervention
Conversational Engagementbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02871921
NCT02871921N/ACompleted

Internet-based Conversational Engagement Clinical Trial

Massachusetts General Hospital·interventional·Posted Aug 18, 2016·Updated Apr 2, 2024

In Brief

A clinical study evaluating Conversational Engagement for Aging and Mild Cognitive Impairment. Completed, enrolled 186 participants across 2 sites.

Detailed Summary

The study aims to randomize 320 (160 Caucasian, 160 African American) socially isolated adults 75+ years old (50:50 split between those with normal cognition and mild cognitive impairment (MCI)) recruited from the community to either the Video Chat Group or the Control Group. The participants in the Video Chat Group will receive a computer and internet service for the duration of the study, which they will use to video chat with study staff for 30 minutes/day 4x/week for 6 months (high dose), and then 2x/week for an additional 6 months (maintenance dose). The efficacy examination of the maintenance dose is limited to an exploratory aim. Both intervention and control groups will have a brief (about 10 minutes) telephone check-in with study staff once per week. In-home testing will occur at Baseline and 6 months. A sub-sample of participants\*\* will be assessed at 12 months (exploratory) after additional 6 months of maintenance dose. All participants at OHSU will have their medication compliance tracked using an electronic medication monitoring device and participants at both OHSU and UM will have MRIs at Baseline and 6 months, if they are able to safely receive MRIs. Participants at both sites will contribute saliva for genetic testing (optional consent), and all video chat and neuropsychological assessment sessions will be recorded for speech and language analysis (consent required for participation).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 18, 2016
Enrollment StartJun 1, 2018
Primary CompletionAug 31, 2021
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 9.9 years ago

Interventions

Conversational Engagementbehavioral

Examine whether increasing social interaction through face-to-face (video chat) conversations could improve cognitive function and whether the efficacy is mediated by improved psychological well-being, targeting older adults aged 75 and older who are socially isolated