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.

Kexin Yu,Mattie Macdonald,Patrick Pruitt,Peter A Lichtenberg,Katherine Wild,Laura M Struble,Jacob Lindsley,Jeffrey A Kaye,Kathleen Potempa,Benjamin M Hampstead,Lisa C Silbert,Hiroko H Dodge,Elena L Alfaro

doi:10.3389/fdgth.2021.714813

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.

Highlights

It is well-established that social isolation and loneliness can lead to adverse health outcomes [1, 2], including dementia [3,4,5]
To addresses the above need, in our previous National Institute on Aging (NIA) funded pilot randomized controlled behavioral clinical trial, we developed a conversation-based social interaction cognitive stimulation protocol delivered by trained interviewers
We introduce the protocol of the active project called “Internet-based conversational engagement clinical trial (I-CONECT), www.i-conect.org” (ClinicalTrials.gov: NCT02871921), a multi-site, assessor-blind, randomized controlled behavioral intervention trial

Summary

Introduction

It is well-established that social isolation (small social network and lack of social contact) and loneliness (dissatisfaction with the frequency and quality of social contact) can lead to adverse health outcomes [1, 2], including dementia [3,4,5]. Enhancing social connectedness or interactions can be a possible intervention strategy to slow down age-associated cognitive decline as well as to delay the symptomatic expression of ADRD. Since delaying the onset of clinical symptoms of dementia even for a few years can have a large impact on the prevalence of dementia [14], developing sustainable easy-to-start social interaction strategies for those with chronic illness and/or who are home-bound (i.e., those at risk of cognitive decline) is of high public health importance. 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. The COVID-19 pandemic related protocol modifications are addressed in the current paper

Objectives

Methods

Findings

Conclusion