Internet-based Conversational Engagement Clinical Trial

Study Overview
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Brief Summary
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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
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**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.

Official Title
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Internet-based Conversational Engagement Clinical Trial

Conditions
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Aging, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Conversational Engagement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 75 or older Consent to MRI (if physically able to receive one) 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 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 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 Sufficient ability to understand English in order to complete protocol-required testing Normal cognition or mild cognitive impairment (MCI), as assessed by the trial neuropsychologist Sufficiently able to comply with protocol assessments and procedures, in the opinion of the investigator Exclusion Criteria: 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 Anticipating major change in living arrangement within the upcoming year Severely depressed, operationally defined as a 15-item GDS score > 7 Significant disease of the central nervous system, such as brain tumor, seizure disorder, subdural hematoma, or significant stroke, per subject report Current (within 2 years of screening) alcohol or substance abuse Unstable or significantly symptomatic psychiatric disorder, such as major depression, schizophrenia, posttraumatic stress disorder, or bipolar disorder Unstable or significantly symptomatic cardiovascular disease, such as coronary artery disease with frequent angina, or congestive heart failure with shortness of breath at rest 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 Active systemic cancer within 5 years of the screening visit (Gleason Grade < 3 prostate cancer and non-metastatic skin cancers are acceptable) Surgery that required full sedation with intubation within 6 months of screening (sedation for minor procedures is acceptable) More than one overnight hospital stay within 3 months of the screening visit 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.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conversational Engagement<br>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<br>* 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<br>|
| No Intervention: Control Group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Efficacy for High Dose : Global Cognitive Function | 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. | Change from baseline to month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Efficacy for High Dose: Language-based executive function | 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. | Change from baseline to month 6 | 
| Intervention Efficacy for High Dose: learning function | 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. | Change from baseline to month 6 | 
| Intervention Efficacy for High Dose: Memory function | 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. | Change from baseline to month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral intervention, social interaction, social isolation, loneliness, dementia, cognitive decline, MRI/fMRI, objective IADL assessment, speech characteristics (acoustic and linguistic), emotional well-being