TY - JOUR
T1 - The Internet-Based Conversational Engagement Clinical Trial (I-CONECT) in Socially Isolated Adults 75+ Years Old
T2 - Randomized Controlled Trial Protocol and COVID-19 Related Study Modifications
AU - Yu, Kexin
AU - Wild, Katherine
AU - Potempa, Kathleen
AU - Hampstead, Benjamin M.
AU - Lichtenberg, Peter A.
AU - Struble, Laura M.
AU - Pruitt, Patrick
AU - Alfaro, Elena L.
AU - Lindsley, Jacob
AU - MacDonald, Mattie
AU - Kaye, Jeffrey A.
AU - Silbert, Lisa C.
AU - Dodge, Hiroko H.
N1 - Publisher Copyright:
© Copyright © 2021 Yu, Wild, Potempa, Hampstead, Lichtenberg, Struble, Pruitt, Alfaro, Lindsley, MacDonald, Kaye, Silbert and Dodge.
PY - 2021/8/25
Y1 - 2021/8/25
N2 - 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.
AB - 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.
KW - ADRD
KW - behavioral intervention
KW - cognitive health
KW - randomized controlled trial
KW - social interaction
KW - social isolation and loneliness
KW - technology–ICT
KW - trial protocol
UR - http://www.scopus.com/inward/record.url?scp=85121367382&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85121367382&partnerID=8YFLogxK
U2 - 10.3389/fdgth.2021.714813
DO - 10.3389/fdgth.2021.714813
M3 - Article
AN - SCOPUS:85121367382
SN - 2673-253X
VL - 3
JO - Frontiers in Digital Health
JF - Frontiers in Digital Health
M1 - 714813
ER -