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      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

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          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.

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          Most cited references57

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          The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment.

          To develop a 10-minute cognitive screening tool (Montreal Cognitive Assessment, MoCA) to assist first-line physicians in detection of mild cognitive impairment (MCI), a clinical state that often progresses to dementia. Validation study. A community clinic and an academic center. Ninety-four patients meeting MCI clinical criteria supported by psychometric measures, 93 patients with mild Alzheimer's disease (AD) (Mini-Mental State Examination (MMSE) score > or =17), and 90 healthy elderly controls (NC). The MoCA and MMSE were administered to all participants, and sensitivity and specificity of both measures were assessed for detection of MCI and mild AD. Using a cutoff score 26, the MMSE had a sensitivity of 18% to detect MCI, whereas the MoCA detected 90% of MCI subjects. In the mild AD group, the MMSE had a sensitivity of 78%, whereas the MoCA detected 100%. Specificity was excellent for both MMSE and MoCA (100% and 87%, respectively). MCI as an entity is evolving and somewhat controversial. The MoCA is a brief cognitive screening tool with high sensitivity and specificity for detecting MCI as currently conceptualized in patients performing in the normal range on the MMSE.
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            Development and validation of brief measures of positive and negative affect: The PANAS scales.

            In recent studies of the structure of affect, positive and negative affect have consistently emerged as two dominant and relatively independent dimensions. A number of mood scales have been created to measure these factors; however, many existing measures are inadequate, showing low reliability or poor convergent or discriminant validity. To fill the need for reliable and valid Positive Affect and Negative Affect scales that are also brief and easy to administer, we developed two 10-item mood scales that comprise the Positive and Negative Affect Schedule (PANAS). The scales are shown to be highly internally consistent, largely uncorrelated, and stable at appropriate levels over a 2-month time period. Normative data and factorial and external evidence of convergent and discriminant validity for the scales are also presented.
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              The diagnosis of dementia due to Alzheimer's disease: Recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease

              The National Institute on Aging and the Alzheimer's Association charged a workgroup with the task of revising the 1984 criteria for Alzheimer's disease (AD) dementia. The workgroup sought to ensure that the revised criteria would be flexible enough to be used by both general healthcare providers without access to neuropsychological testing, advanced imaging, and cerebrospinal fluid measures, and specialized investigators involved in research or in clinical trial studies who would have these tools available. We present criteria for all-cause dementia and for AD dementia. We retained the general framework of probable AD dementia from the 1984 criteria. On the basis of the past 27 years of experience, we made several changes in the clinical criteria for the diagnosis. We also retained the term possible AD dementia, but redefined it in a manner more focused than before. Biomarker evidence was also integrated into the diagnostic formulations for probable and possible AD dementia for use in research settings. The core clinical criteria for AD dementia will continue to be the cornerstone of the diagnosis in clinical practice, but biomarker evidence is expected to enhance the pathophysiological specificity of the diagnosis of AD dementia. Much work lies ahead for validating the biomarker diagnosis of AD dementia. Copyright © 2011. Published by Elsevier Inc.
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                Author and article information

                Contributors
                Journal
                Front Digit Health
                Front Digit Health
                Front. Digit. Health
                Frontiers in Digital Health
                Frontiers Media S.A.
                2673-253X
                25 August 2021
                2021
                25 August 2021
                : 3
                : 714813
                Affiliations
                [1] 1Suzanne Dworak-Peck School of Social Work, University of Southern California , Los Angeles, CA, United States
                [2] 2Edward R. Roybal Institute on Aging, University of Southern California , Los Angeles, CA, United States
                [3] 3Layton Aging and Alzheimer's Disease Center, Department of Neurology, Oregon Health & Science University , Portland, OR, United States
                [4] 4Department of Systems, Populations and Leadership, University of Michigan School of Nursing , Ann Arbor, MI, United States
                [5] 5Mental Health Service, Veterans Affairs Medical Center Ann Arbor Healthcare System , Ann Arbor, MI, United States
                [6] 6Research Program on Cognition and Neuromodulation Based Interventions, Department of Psychiatry, University of Michigan , Ann Arbor, MI, United States
                [7] 7The Institute of Gerontology, Wayne State University , Detroit, MI, United States
                [8] 8Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan , Ann Arbor, MI, United States
                [9] 9Department of Psychiatry, University of Wisconsin-Madison , Madison, WI, United States
                [10] 10The School of Psychological Science, Oregon State University , Corvallis, OR, United States
                [11] 11Syneos Health , Portland, OR, United States
                Author notes

                Edited by: Giuseppe Fico, Polytechnic University of Madrid, Spain

                Reviewed by: Shekh Md Mahmudul Islam, University of Dhaka, Bangladesh; Patricia Abril, Polytechnic University of Madrid, Spain

                *Correspondence: Hiroko H. Dodge dodgeh@ 123456ohsu.edu

                This article was submitted to Connected Health, a section of the journal Frontiers in Digital Health

                Article
                10.3389/fdgth.2021.714813
                8521795
                34713183
                d14029c8-41ed-44c8-86f3-82dbd87e5fde
                Copyright © 2021 Yu, Wild, Potempa, Hampstead, Lichtenberg, Struble, Pruitt, Alfaro, Lindsley, MacDonald, Kaye, Silbert and Dodge.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 25 May 2021
                : 15 July 2021
                Page count
                Figures: 2, Tables: 3, Equations: 0, References: 57, Pages: 14, Words: 10886
                Funding
                Funded by: National Institute on Aging, doi 10.13039/100000049;
                Award ID: P30AG024978
                Award ID: P30AG053760
                Award ID: P30AG066518
                Award ID: R01AG051628
                Award ID: R01AG056102
                Award ID: R01AG056712
                Categories
                Digital Health
                Study Protocol

                adrd,behavioral intervention,randomized controlled trial,trial protocol,cognitive health,social interaction,technology–ict,social isolation and loneliness

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