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

Mass General Brigham

Status: Completed

Conditions: Aging; Mild Cognitive Impairment

Treatments: Behavioral: Conversational Engagement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02871921

R01AG056102 (U.S. NIH Grant/Contract)

2023p000367

R01AG051628 (U.S. NIH Grant/Contract)

R56AG056102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 186 patients

Sex: All

Ages: 75+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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186 participants in 2 patient groups

Conversational Engagement

Experimental group

Description:

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.

Treatment:

Behavioral: Conversational Engagement

Control Group

No Intervention group

Description:

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