The Internet-Based Conversational Engagement Clinical Trial (I-CONECT) in Socially Isolated Adults 75+ Years Old: Randomized Controlled Trial Protocol and COVID-19 Related Study Modifications

Abstract

Background: Increasing social interactions through communication technologies could offer a cost-effective prevention approach that slows cognitive decline and delays the onset of Alzheimer's disease. This paper describes the protocol of an active project named “Internet-based conversational engagement clinical trial (I-CONECT)” (ClinicalTrials.gov: NCT02871921). The COVID-19 pandemic related protocol modifications are also addressed in the current paper.Methods: I-CONECT is a multi-site, assessor-blind, randomized controlled behavioral intervention trial (RCT). We aim to randomize 320 socially isolated adults 75+ years old [160 Caucasian and 160 African American participants, 50:50 split between those with normal cognition and mild cognitive impairment (MCI)] recruited from the community to either the video chat intervention group or the control group (1:1 allocation). Those in the video chat group receive a computer and Internet service for the duration of the study, which they use to video chat with study staff for 30 min/day 4×/week for 6 months (high dose), and then 2×/week for an additional 6 months (maintenance dose). Both video chat and control groups have a brief (about 10 min) telephone check-in with study staff once per week. The primary outcome is the change in global cognitive function measured by Montreal Cognitive Assessment (MoCA) from baseline to 6 months. Secondary outcomes include changes in cognition in memory and executive function domains, emotional well-being measured by NIH Toolbox emotional battery, and daily functional abilities assessed with the Revised Observed Tasks of Daily Living (OTDL-R). Eligible participants have MRIs at baseline and 6 months. Participants contribute saliva for genetic testing (optional consent), and all video chats, weekly check-in calls and neuropsychological assessment sessions are recorded for speech and language analysis. The pandemic halted research activities and resulted in protocol modifications, including replacing in-person assessment with remote assessment, remote deployment of study equipment, and revised targeted sample size.Discussion: This trial provides user-friendly hardware for the conversational-based intervention that can be easily provided at participants' homes. The trial aspires to use age and culture-specific conversational materials and a related platform developed in this trial for enhancing cognitive reserve and improving cognitive function.

The Joint Effects of Acoustic and Linguistic Markers for Early Identification of Mild Cognitive Impairment

“…We obtained transcripts and audio recordings from an ongoing single blind randomized controlled clinical trial (Clinicaltrials.gov: NCT02871921) (14). Briefly, this clinical trial [aka, Internet-Based Conversational Engagement Clinical Trial: www.i-conect.org (I-CONECT)] aims to enhance cognitive functions and psychological well-being of older adults aged 75 and older by means of social interactions using video chats.…”

“…The trial is funded by the National Institute of Health and developed based on the cumulative epidemiological findings that social isolation is a risk factor of dementia and therefore increasing social interactions may provide a buffer against cognitive decline among older adults (15,16). The detail protocol and inclusion and exclusion criteria are found elsewhere (14). The ongoing study is an extension of a previous pilot project, conducted in the United States of America, which found promising results in terms of improvement in cognitive functions post-intervention (17).…”

“…The study procedures were reviewed and approved by the Institutional Review Board (IRB) at Oregon Health & Science University (OHSU) IRB STUDY00015937 (14). All participants signed the informed consent form.…”

Detection of Mild Cognitive Impairment from Language Markers with Crossmodal Augmentation

“… 9 – 14 For example, language markers can be used in conversational agents deployed on mobile devices or smart speakers to obtain a risk assessment of MCI. 9 However, the investigation of language markers is still in the early phase, where a critical issue is that the cohort sizes for studying language markers remain very limited, 15 demanding more data to unleash their power.…”

“…However, one significant barrier to the multi-modality joint analysis is that in typical cohorts, there are only very limited subjects that have both imaging and language modalities. For example, in a cohort study from the I-CONECT clinical trial, 15 there are 40 subjects randomized for the experimental group for whom language makers (semi-structured conversations) are available. Yet among these subjects, there are only 16 subjects who have MRI scans available in the National Alzheimer’s Coordinating Center (NACC) medical records.…”