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

This study is not yet open for participant recruitment.
Verified September 2017 by Hiroko H. Dodge, Oregon Health and Science University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02871921
First Posted: August 18, 2016
Last Update Posted: October 3, 2017
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.
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
  Purpose
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 and 12 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.

Condition Intervention
Aging Mild Cognitive Impairment Behavioral: Conversational Engagement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Internet-based Conversational Engagement Clinical Trial

Further study details as provided by Hiroko H. Dodge, Oregon Health and Science University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 360
Anticipated Study Start Date: January 2018
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   80 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 80 or older;
  • Living alone;
  • Marital status of widowed, widower or single;
  • Socially isolated based on social isolation score;
  • Not severely depressed;
  • Willing to undergo MRI (if physically possible) and contribute saliva for genetic testing;
  • Living independently (independent in any items in Old Americans Resources and services Programs (OARS) Activities of Daily Living (ADL), (partial assistance in items in OARS Instrumental Activities of Daily Living (IADL) are allowed);
  • Normal cognition or early Mild Cognitive Impairment, determined by neuropsychological testing and consensus diagnoses by neuropsychologists at Alzheimer's Disease Centers;
  • Adequate vision and hearing to use study technology and undergo testing;
  • Sufficient ability to understand English in order to complete the testing and engage in conversation with study staff;

Exclusion Criteria:

  • Plans to start taking classes, travel, or attend significant social events during the intervention period;
  • Disease associated with dementia;
  • Significant disease of the central nervous system;
  • Current or recent alcohol or substance abuse;
  • Major psychiatric disorder;
  • Unstable or significantly symptomatic cardiovascular disease;
  • Unstable insulin-dependent diabetes mellitus;
  • Active or recent systemic cancer;
  • Any illness that requires >1 visit per month to a clinician;
  • Progressive vision loss that is already beginning to significantly degrade vision;
  • Need for oxygen supplementation;
  • Frequent use of high doses of analgesics;
  • Sedative medications other than those used occasionally for sleep.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871921


Contacts
Contact: Elena Goodrich, BA 503.494.9043 goodrice@ohsu.edu

Sponsors and Collaborators
Oregon Health and Science University
University of Michigan
National Institute on Aging (NIA)
Wayne State University
Investigators
Principal Investigator: Hiroko Dodge, PhD Oregon Health and Science Univeristy
  More Information

Publications:
Responsible Party: Hiroko H. Dodge, PhD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02871921     History of Changes
Other Study ID Numbers: STUDY00015937
R56AG056102 ( U.S. NIH Grant/Contract )
R01AG051628 ( U.S. NIH Grant/Contract )
First Submitted: August 8, 2016
First Posted: August 18, 2016
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hiroko H. Dodge, Oregon Health and Science University:
Behavioral prevention
social interaction
dementia
MRI

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders