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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by Oregon Health and Science University
Sponsor:
Collaborators:
University of Michigan
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Hiroko H. Dodge, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT02871921
First received: August 8, 2016
Last updated: October 24, 2016
Last verified: October 2016
  Purpose

In the proposed project, we will provide 30 minutes face-to-face communications with interviewers through internet/webcam 4 times per week for 24 weeks, followed by sustaining dose of 2 times per week of 30 minutes session for additional 24 weeks (Experimental Group). The Control Group will receive once per week phone call which lasts less than 5 minutes where interviewers ask brief questions to monitor their social activities and any changes in health conditions. The primary outcomes are pre-post changes in cognitive test scores and exploratory outcomes are structural and functional pre-post changes in specific brain regions measured by MRI and resting state fMRI.

This is a multi-site study where study participants will be recruited at OHSU and University of Michigan (UM). Study recruitment, interview (prevention trial), data entry, and MRI assessment will be conducted at both sites.


Condition Intervention Phase
Aging
Mild Cognitive Impairment
Behavioral: Conversational Engagement
Phase 1
Phase 2

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

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Intervention Efficacy [ Time Frame: Change from baseline cognitive test scores at 6 months and 1 year ]
    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
Study Start Date: May 2017
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 minutes 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).
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 5 minutes; interviewers ask brief questions to monitor their social activities and health conditions

  Eligibility

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 blood draw 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;
  • Active or recent systemic cancer;
  • Any illness that requires >1 visit per month to a clinician;
  • Progressive vision loss;
  • Need for oxygen supplementation;
  • Frequent use of high doses of analgesics;
  • Sedative medications other than those used occasionally for sleep.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
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
R56AG056102-01 ( US NIH Grant/Contract Award Number )
R01AG051628-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: August 8, 2016
Last Updated: October 24, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Oregon Health and Science University:
Behavioral prevention
social interaction
dementia
MRI

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on March 24, 2017