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

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ClinicalTrials.gov Identifier: NCT02871921
Recruitment Status : Recruiting
First Posted : August 18, 2016
Last Update Posted : April 4, 2019
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

Brief Summary:
At each site (OHSU & UM), 160 socially isolated adults 75+ years old will be recruited from the community and randomized to either the Video Chat Group or the Control Group. Those in the Video Chat Group will receive a computer and internet service 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 (high dose), and then 2x/week for an additional 6 months (maintenance dose). Both intervention and control groups will have a brief (about 10 minutes) telephone check-in 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 an electronic medication monitoring device and all 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 and neuropsychological assessment sessions will be recorded for speech and language analysis.

Condition or disease Intervention/treatment Phase
Aging Mild Cognitive Impairment Behavioral: Conversational Engagement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Study assessors will be blinded to the subject study arm assignment.
Primary Purpose: Prevention
Official Title: Internet-based Conversational Engagement Clinical Trial
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2022

Arm Intervention/treatment
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. Participants will also receive a phone call once per week that lasts approximately 10 minutes; interviewers ask brief questions to monitor participant social activities and health conditions.
Behavioral: Conversational Engagement
Examine whether increasing social interaction through face-to-face (video chat) conversations could improve cognitive function, targeting seniors aged 75 and older who are socially isolated

No Intervention: Control Group
Participants will receive a phone call once per week that lasts approximately 10 minutes; interviewers ask brief questions to monitor participant social activities and health conditions



Primary Outcome Measures :
  1. Intervention Efficacy for High Dose [ Time Frame: Change from baseline to month 6 ]
    Cognitive test scores of executive and memory functions using the National Alzheimer's Coordinating Center Uniform Data Set Neuropsychological Battery (UDS V3)

  2. Intervention Efficacy for Maintenance Dose [ Time Frame: Change from month 6 to month 12 ]
    Cognitive test scores of executive and memory functions using the National Alzheimer's Coordinating Center Uniform Data Set Neuropsychological Battery (UDS V3)


Secondary Outcome Measures :
  1. Intervention Efficacy for High Dose: Instrumental activities of daily living (IADL) [ Time Frame: Change from baseline to month 6 ]
    The Revised Observational Tasks of Daily Living (OTDL-R)

  2. Intervention Efficacy for Maintenance Dose: Instrumental activities of daily living (IADL) functions [ Time Frame: Change from month 6 to month 12 ]
    The Revised Observational Tasks of Daily Living (OTDL-R)


Other Outcome Measures:
  1. Exploratory Analysis: Cognitive Tests by NIH Toolbox [ Time Frame: Change from baseline to month 6 ]
    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.

  2. Exploratory Analysis: Cognitive Tests by NIH Toolbox [ Time Frame: Change from month 6 to month 12 ]
    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.

  3. Exploratory Analysis: structural and functional MRI [ Time Frame: Change from baseline at 6 months ]
    Examine region specific structural and functional pre-post changes in brain using magnetic resonance imaging (MRI)

  4. Exploratory Analysis: 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

  5. Exploratory Analysis: Speech and Language Characteristics [ Time Frame: Change from baseline to month 12 ]
    Examine whether the intervention could lead to changes in speech and language characteristics over time by analyzing recorded video chats in the experimental group

  6. Exploratory Analysis: Combined Effect of High and Maintenance Doses [ Time Frame: Change from baseline to month 12 ]
    Changes in primary and secondary outcomes for the combined effects of receiving both high (4 times per week for 6 months) and maintenance (2 times per week for 6 months) doses of the intervention.

  7. Exploratory Analysis. Intervention Efficacy for High Dose: Medication adherence measured by electronic pill box (digital biomarker) [ Time Frame: Change from baseline to month 6 ]
    Measured by the number of days a subject uses their electronic pillbox, and for those days it is used, the difference between a given target time and the actual time the pillbox is opened.

  8. Exploratory Analysis. Intervention Efficacy for Maintenance Dose: Medication adherence measured by electronic pill box (digital biomarker) [ Time Frame: Change from month 6 to month 12 ]
    Measured by the number of days a subject uses their electronic pillbox, and for those days it is used, the difference between a given target time and the actual time the pillbox is opened.



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 75 or older
  2. Consent to MRI (if physically able to receive one) and APOE4 genotype assessment
  3. Socially isolated, defined by at least one of the following:

    i. Score ≤12 on the 6-item Lubben Social Network Scale (LSNS-6), ii. Engages in conversations lasting 30 minutes or longer no more than twice per week, per subject self-report

  4. Adequate vision to use study technology and complete all neuropsychological tests throughout the study, defined by the following two criteria:

    i. See well enough to complete the MoCA ii. See well enough to read a newspaper, wearing glasses if needed but not using a magnifying glass

  5. Adequate hearing to use study technology and complete all neuropsychological tests throughout the study, defined as i. Able to hear well enough to complete the telephone screening ii. Able to hear well enough to complete the MoCA
  6. Sufficient ability to understand English in order to complete protocol-required testing
  7. Normal cognition or mild cognitive impairment (MCI), as assessed by the trial neuropsychologist
  8. Sufficiently able to comply with protocol assessments and procedures, in the opinion of the investigator

Exclusion Criteria:

  1. Identified as having dementia based on either of the following criteria:

    i. Self-reported diseases associated with dementia, such as Alzheimer's disease, vascular dementia, Lewy body dementia, frontotemporal dementia, normal pressure hydrocephalus, or Parkinson's disease ii. Diagnosis of dementia by trial neuropsychologist

  2. Anticipating major change in living arrangement within the upcoming year
  3. Severely depressed, operationally defined as a 15-item GDS score > 7
  4. Significant disease of the central nervous system, such as brain tumor, seizure disorder, subdural hematoma, or significant stroke, per subject report
  5. Current (within 2 years of screening) alcohol or substance abuse
  6. Unstable or significantly symptomatic psychiatric disorder, such as major depression, schizophrenia, posttraumatic stress disorder, or bipolar disorder
  7. Unstable or significantly symptomatic cardiovascular disease, such as coronary artery disease with frequent angina, or congestive heart failure with shortness of breath at rest
  8. Unstable insulin-dependent diabetes mellitus, defined as meeting any of the following criteria:

    i. Received a diagnosis of Type 1 Diabetes ii. Started taking insulin within 3 months of the screening visit iii. Been hospitalized for hypoglycemia within one year of screening

  9. Active systemic cancer within 5 years of the screening visit (Gleason Grade < 3 prostate cancer and non-metastatic skin cancers are acceptable)
  10. Surgery that required full sedation with intubation within 6 months of screening (sedation for minor procedures is acceptable)
  11. More than one overnight hospital stay within 3 months of the screening visit
  12. Any other condition that, in the opinion of the investigator, is severe enough to cause study participation to have a negative impact on participant or study team rights or wellbeing.

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
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Contact: Study Coordinator 503-494-9043 I-CONECT@ohsu.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Alexis Ellis, BBA    734-647-2676    ellisal@ohsu.edu   
Contact: Jesica Pedroza, BA    734-763-6669    pedroza@ohsu.edu   
Principal Investigator: Benjamin Hampstead, PhD         
Principal Investigator: Kathleen Potempa, PhD, RN, FAAN         
Principal Investigator: Laura Struble, PhD, GNP-BC         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Study Coordinator    503-494-9043    I-CONECT@ohsu.edu   
Contact: Jacob Lindsley, MA    503-494-9043    lindslja@ohsu.edu   
Principal Investigator: Hiroko H Dodge, PhD         
Sponsors and Collaborators
Oregon Health and Science University
University of Michigan
National Institute on Aging (NIA)
Wayne State University
Investigators
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Principal Investigator: Hiroko Dodge, PhD Oregon Health and Science Univeristy

Additional Information:
Publications:
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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 )
R01AG056102 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 intervention
social interaction
social isolation
MRI/fMRI
dementia
electronic pill box
objective IADL assessment
speech characteristics

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