ClinicalTrials.gov
ClinicalTrials.gov Menu

Internet-based Conversational Engagement Clinical Trial (I-CONECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02871921
Recruitment Status : Recruiting
First Posted : August 18, 2016
Last Update Posted : July 17, 2018
Sponsor:
Collaborators:
University of Michigan
National Institute on Aging (NIA)
Wayne State University
Information provided by (Responsible Party):
Hiroko H. Dodge, Oregon Health and Science University

August 8, 2016
August 18, 2016
July 17, 2018
June 1, 2018
July 2020   (Final data collection date for primary outcome measure)
  • Intervention Efficacy [ Time Frame: Change from baseline cognitive test scores at 6 months ]
    Examine the intervention's efficacy using cognitive test scores of executive and memory functions using the National Alzheimer's Coordinating Center Uniform Data Set Neuropsychological Battery
  • Intervention Efficacy [ Time Frame: Change from baseline cognitive test scores at 12 months ]
    Examine the intervention's efficacy using cognitive test scores of executive and memory functions using the National Alzheimer's Coordinating Center Uniform Data Set Neuropsychological Battery
  • Intervention Efficacy [ Time Frame: Change from baseline cognitive test scores at 6 months ]
    Examine the intervention's efficacy using cognitive test scores of executive and memory functions using the National Alzheimer's Coordinating Center Uniform Data Set Battery
  • Intervention Efficacy [ Time Frame: Change from baseline cognitive test scores at 12 months ]
    Examine the intervention's efficacy using cognitive test scores of executive and memory functions using the National Alzheimer's Coordinating Center Uniform Data Set Battery
Complete list of historical versions of study NCT02871921 on ClinicalTrials.gov Archive Site
  • Exploratory Analysis of Cognitive Tests [ Time Frame: Change from baseline NIH toolbox cognitive test scores at 6 months ]
    Examine the intervention's efficacy on the same cognitive domains (executive and memory functions) using the NIH-Toolbox computerized cognitive test battery for cross-validation of domain responsiveness of our intervention.
  • Exploratory Analysis of Cognitive Tests [ Time Frame: Change from baseline NIH toolbox cognitive test scores at 12 months ]
    Examine the intervention's efficacy on the same cognitive domains (executive and memory functions) using the NIH-Toolbox computerized cognitive test battery for cross-validation of domain responsiveness of our intervention.
  • Underlying Mechanisms of Efficacy [ Time Frame: Change from baseline at 6 months ]
    Examine region specific structural and functional pre-post changes in brain using magnetic resonance imaging (MRI)
  • Exploratory Analysis of Speech and Language Characteristics [ Time Frame: Change from baseline at 6 months ]
    Examine whether the intervention could lead to changes in speech and language characteristics over time by analyzing recorded video chats in the experimental group
  • Exploratory Analysis of Speech and Language Characteristics [ Time Frame: Change from baseline at 12 months ]
    Examine whether the intervention could lead to changes in speech and language characteristics over time by analyzing recorded video chats in the experimental group
  • Examine translational effects of improvements in cognitive functions in medication adherence [ Time Frame: Change from baseline at 6 months ]
    Two ecologically valid functional outcome measures sensitive to trial effects have been chosen: the Revised Observational Tasks of Daily Living (OTDL-R) and a MedTracker device that monitors in-home daily medication adherence.
  • Examine translational effects of improvements in cognitive functions in medication adherence [ Time Frame: Change from baseline at 12 months ]
    Two ecologically valid functional outcome measures sensitive to trial effects have been chosen: the Revised Observational Tasks of Daily Living (OTDL-R) and a MedTracker device that monitors in-home daily medication adherence.
  • Exploratory Analysis of Cognitive Tests [ Time Frame: Change from baseline NIH toolbox cognitive test scores at 6 months ]
    Examine the intervention's efficacy on the same cognitive domains (executive and memory functions) using the NIH-Toolbox computerized cognitive test battery for cross-validation of domain responsiveness of our intervention.
  • Exploratory Analysis of Cognitive Tests [ Time Frame: Change from baseline NIH toolbox cognitive test scores at 12 months ]
    Examine the intervention's efficacy on the same cognitive domains (executive and memory functions) using the NIH-Toolbox computerized cognitive test battery for cross-validation of domain responsiveness of our intervention.
  • Underlying Mechanisms of Efficacy [ Time Frame: Change from baseline at 6 months ]
    Examine region specific structural and functional pre-post changes in brain using magnetic resonance imaging (MRI)
Not Provided
Not Provided
 
Internet-based Conversational Engagement Clinical Trial
Internet-based Conversational Engagement Clinical Trial
At each site (OHSU & UM), 180 socially isolated adults 80+ years old will be recruited through Meals on Wheels People. Participants will be randomized to either the Video Chat Group or the Control Group. Those in the Video Chat Group will receive a computer 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, and then they will video chat 2x/week for another 6 months. Those assigned to the Control Group will have brief telephone check-ins with study staff once per week. In-home testing will occur at Baseline, 6 months, 12 months, and 18 months. All participants at OHSU will have their medication compliance tracked using electronic medication monitoring devices (MedTracker) and 50% of participants at both OHSU and UM will have MRIs at Baseline and 6 months, if they are able to safely receive MRIs. All participants at both sites will contribute saliva for genetic testing, and all video chat sessions will be recorded for speech and language analysis.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Aging
  • Mild Cognitive Impairment
Behavioral: Conversational Engagement
Examine whether increasing social interaction through face-to-face conversations could improve cognitive functions, targeting seniors aged 80 and older who are socially isolated
  • Experimental: Conversational Engagement
    Participants engage in 30-minute face-to-face communications with study staff through internet/webcam 4 times per week for 24 weeks (6 months), followed by sustaining dose of 2 times per week of 30 minutes session for additional 24 weeks (6 months). Conversational staff will facilitate content-standardized but naturalistic-style social engagement. Staff and participants will engage in conversation about a wide variety of topics that are culturally and personally relevant and interesting to participants. Each day, participants will be able to choose from two topics.
    Intervention: Behavioral: Conversational Engagement
  • No Intervention: Control Group
    Participants will receive a phone call once per week that lasts less than 10 minutes; interviewers ask brief questions to monitor their social activities and health conditions
Dodge HH, Zhu J, Mattek N, Bowman M, Ybarra O, Wild K, Loewenstein DA, Kaye JA. Web-enabled Conversational Interactions as a Means to Improve Cognitive Functions: Results of a 6-Week Randomized Controlled Trial. Alzheimers Dement (N Y). 2015 May;1(1):1-12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
160
July 2021
July 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 80 or older;
  • Consent for MRI (if physically able to receive one) and APOE4 genotype assessment;
  • Socially isolated, defined by the following three criteria:
  • Answer "yes" to the question: "Do you eat most of your meals alone?",
  • Live alone, and
  • Score <12 on the 6-item Lubben Social Network Scale;
  • Adequate vision to use study technology and complete all neuropsychological tests throughout the study, defined by the following two criteria:
  • See well enough to complete the MoCA, and
  • Not have received a diagnosis related to progressive vision loss;
  • Adequate hearing to use study technology and complete all neuropsychological tests throughout the study, defined but the following two criteria:
  • Hear well enough to complete the telephone screening, and
  • Hear well enough to complete the MoCA;
  • Sufficient ability to understand English in order to complete the testing (initial eligibility determined by completing telephone screening and MoCA); and
  • Normal cognition or early-stage mild cognitive impairment (MCI), operationally defined as an age-, education-, and gender-adjusted Z score on the MoCA of ≥ -1.5 at the OHSU study site and ≥ -2.0 at the UM study site. The spreadsheet to be used for calculating the Z-score can be found at https://www.alz.washington.edu/WEB/npsych_means.html.

Exclusion Criteria:

  • Identified as having dementia based on either of the following criteria:
  • Self-reported diseases associated with dementia
  • Diagnosis of dementia by expert neuropsychologists
  • Anticipating major change in living arrangement within the upcoming year;
  • Severely depressed, operationally defined as a 15-item GDS score > 7;
  • Current (within the last 2 years) alcohol or substance abuse;
  • Unstable or significantly symptomatic cardiovascular disease;
  • Unstable insulin-dependent diabetes mellitus, defined as meeting any of the following criteria:
  • Received a diagnosis of Type 1 Diabetes,
  • Started taking insulin less than 3 months ago, or
  • Been hospitalized for hypoglycemia within the past year;
  • Active systemic cancer within 5 years of study entry;
  • Need for oxygen supplementation for adequate daytime functioning;
  • Surgery that required full sedation with intubation within the past 6 months; or
  • More than one overnight hospital stay within the past 3 months.
Sexes Eligible for Study: All
80 Years and older   (Older Adult)
Yes
Contact: Elena Goodrich, BA 503-494-9043 goodrice@ohsu.edu
United States
 
 
NCT02871921
STUDY00015937
R56AG056102 ( U.S. NIH Grant/Contract )
R01AG051628 ( U.S. NIH Grant/Contract )
R01AG056102 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Hiroko H. Dodge, Oregon Health and Science University
Oregon Health and Science University
  • University of Michigan
  • National Institute on Aging (NIA)
  • Wayne State University
Principal Investigator: Hiroko Dodge, PhD Oregon Health and Science Univeristy
Oregon Health and Science University
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP