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

• ClinicalTrials.gov Identifier: NCT02871921
• Recruitment Status: Completed
• First Posted: August 18, 2016
• Last Update Posted: September 23, 2021
• Sponsor: Oregon Health and Science University
• 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

Tracking Information

• First Submitted Date: August 8, 2016
• First Posted Date: August 18, 2016
• Last Update Posted Date: September 23, 2021
• Actual Study Start Date: June 1, 2018
• Actual Primary Completion Date: August 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 13, 2020)

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.

Original Primary Outcome Measures (submitted: August 15, 2016)

• 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

Current Secondary Outcome Measures (submitted: August 13, 2020)

• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: August 15, 2016)

• 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)

Current Other Pre-specified Outcome Measures (submitted: August 13, 2020)

• 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.
• 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
• 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)
• 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
• 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
• 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.
• 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.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Internet-based Conversational Engagement Clinical Trial
• Official Title: Internet-based Conversational Engagement Clinical Trial
• Brief Summary: The study aims to randomize 320 (160 Caucasian, 160 African American) socially isolated adults 75+ years old (50:50 split between those with normal cognition and mild cognitive impairment (MCI)) recruited from the community to either the Video Chat Group or the Control Group. The participants 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 participants at both OHSU and UM will have MRIs at Baseline and 6 months, if they are able to safely receive MRIs. Participants at both sites will contribute saliva for genetic testing (optional consent), and all video chat and neuropsychological assessment sessions will be recorded for speech and language analysis (consent required for participation).
• Detailed Description: **Due to COVID-19 pandemic and resultant research hiatus and the subsequent changes in assessment modality from in-person to telephone (T-COG) assessments, M12 (Months 12) assessments are conducted only among those who completed M12 assessments before March, 18, 2020.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Aging
• Mild Cognitive Impairment

Intervention

Behavioral: Conversational Engagement

Examine whether increasing social interaction through face-to-face (video chat) conversations could improve cognitive function and whether the efficacy is mediated by improved psychological well-being, targeting older adults aged 75 and older who are socially isolated

Study Arms

• 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.
  Intervention: Behavioral: Conversational Engagement
• 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

Publications *

• 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. doi: 10.1016/j.trci.2015.01.001.
• Dodge HH, Katsumata Y, Zhu J, Mattek N, Bowman M, Gregor M, Wild K, Kaye JA. Characteristics associated with willingness to participate in a randomized controlled behavioral clinical trial using home-based personal computers and a webcam. Trials. 2014 Dec 23;15:508. doi: 10.1186/1745-6215-15-508.
• Asgari M, Kaye J, Dodge H. Predicting mild cognitive impairment from spontaneous spoken utterances. Alzheimers Dement (N Y). 2017 Feb 27;3(2):219-228. doi: 10.1016/j.trci.2017.01.006. eCollection 2017 Jun.
• Tang F, Uchendu I, Wang F, Dodge HH, Zhou J. Scalable diagnostic screening of mild cognitive impairment using AI dialogue agent. Sci Rep. 2020 Mar 31;10(1):5732. doi: 10.1038/s41598-020-61994-0.
• Cerino ES, Hooker K, Goodrich E, Dodge HH. Personality Moderates Intervention Effects on Cognitive Function: A 6-Week Conversation-Based Intervention. Gerontologist. 2020 Jul 15;60(5):958-967. doi: 10.1093/geront/gnz063.
• Tang F, Chen J, Dodge HH, Zhou J. The Joint Effects of Acoustic and Linguistic Markers for Early Identification of Mild Cognitive Impairment. Front Digit Health. 2022 Feb 11;3:702772. doi: 10.3389/fdgth.2021.702772. eCollection 2021.
• Yu K, Wild K, Potempa K, Hampstead BM, Lichtenberg PA, Struble LM, Pruitt P, Alfaro EL, Lindsley J, MacDonald M, Kaye JA, Silbert LC, Dodge HH. The Internet-Based Conversational Engagement Clinical Trial (I-CONECT) in Socially Isolated Adults 75+ Years Old: Randomized Controlled Trial Protocol and COVID-19 Related Study Modifications. Front Digit Health. 2021 Aug 25;3:714813. doi: 10.3389/fdgth.2021.714813. eCollection 2021.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 21, 2021): 186
• Original Estimated Enrollment (submitted: August 15, 2016): 160
• Actual Study Completion Date: August 31, 2021
• Actual Primary Completion Date: August 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Age 75 or older
2. Consent to MRI (if physically able to receive one)

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, front temporal 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 75 Years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02871921
• Other Study ID Numbers: STUDY00015937; R56AG056102 ( U.S. NIH Grant/Contract ); R01AG051628 ( U.S. NIH Grant/Contract ); R01AG056102 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

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.

• Current Responsible Party: Hiroko H. Dodge, Oregon Health and Science University
• Original Responsible Party: Same as current
• Current Study Sponsor: Oregon Health and Science University
• Original Study Sponsor: Same as current

Collaborators

• University of Michigan
• National Institute on Aging (NIA)
• Wayne State University
• Emory University

Investigators

• Principal Investigator: Hiroko Dodge, PhD; Oregon Health and Science Univeristy

• PRS Account: Oregon Health and Science University
• Verification Date: September 2021