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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 : August 17, 2020
Sponsor:
Collaborators:
University of Michigan
National Institute on Aging (NIA)
Wayne State University
Emory University
Information provided by (Responsible Party):
Hiroko H. Dodge, Oregon Health and Science University

Brief Summary:
We aim to randomize 320 socially isolated adults 75+ years old recruited from the community 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). The efficacy examination of the maintenance dose is limited to an exploratory aim. 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 and 6 months. A sub-sample of participants will be assessed at 12 months (exploratory) after additional 6 months of maintenance dose. 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 : 180 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 : September 30, 2021
Estimated Study Completion Date : October 31, 2021

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). Under an exploratory aim, a limited number of participants will be further 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 topic options. 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 : Global Cognitive Function [ Time Frame: Change from baseline to month 6 ]
    Global cognitive function measured by the Montreal Cognitive Assessment total score (MoCA total score). Montreal Cognitive Assessment is a neuropsychological test. Total score ranges from 0 to 30. Higher scores indicate better cognitive function.


Secondary Outcome Measures :
  1. Intervention Efficacy for High Dose: Language-based executive function [ Time Frame: Change from baseline to month 6 ]
    Cognitive function in language-based executive function measured by Verbal Fluency Animal test. Verbal fluency Animals test is a neuropsychological test. In the test, participants have to produce as many words as possible from a category of animals within 60 seconds. Total score ranges from 0 to 70. Higher scores indicate better cognitive function.

  2. Intervention Efficacy for High Dose: learning function [ Time Frame: Change from baseline to month 6 ]
    Cognitive function in a learning domain (immediate recall) measured by Craft Story Immediate Recall test (paraphrase scoring). Craft Story Immediate Recall test (paraphrase scoring) is a neuropsychological test. Total score ranges from 0 to 25. Higher scores indicate better cognitive function.

  3. Intervention Efficacy for High Dose: Memory function [ Time Frame: Change from baseline to month 6 ]
    Cognitive function in a memory domain measured by Craft Story Delayed Recall test scores (paraphrase scoring). Craft Story Delayed Recall test (paraphrase scoring) is a neuropsychological test. Total score ranges from 0 to 25. Higher scores indicate better cognitive function.

  4. Intervention Efficacy for High Dose: objectively assessed IADL (Instrumental Activities of Daily Living) functions [ Time Frame: Change from baseline to month 6 ]
    The Revised Observational Tasks of Daily Living (OTDL-R) includes a total of 9 IADL tasks (28 items, maximum score = 28), three each in the domains of medication use, telephone use, and financial management. The higher score indicates better function.


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 for cross-validation of domain responsiveness of our intervention.

  2. Exploratory Analysis: Emotional battery by NIH Toolbox [ Time Frame: Change from month 6 to month 12 ]
    Examine the intervention's efficacy on psychological well-being using the NIH-Toolbox emotional battery test scores

  3. Exploratory Analysis: structural and resting state 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, fMRI)

  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 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

  6. 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.

  7. Exploratory Analysis. Intervention Efficacy for Maintenance Dose: Medication adherence measured by electronic pill box (digital biomarker) [ Time Frame: Change from baseline 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 iii. Answers "Often" to at least one question on the Hughes et al. Three-Item Loneliness Scale

  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   
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
Emory 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    
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: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All de-identified subject data will stored in a data repository at the conclusion of the research, and made available to approved investigators per a repository protocol.
Time Frame: Data will be available once main trial analyses have concluded, and will be available indefinitely.
Access Criteria: Investigators may access trial data via a repository data sharing request process. Data access will be granted to achieve the aims as outlined in approved data requests. IRB approval may be required.

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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