Internet-based Conversational Engagement Clinical Trial

(I-CONECT Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Hiroko Dodge, PhD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Hiroko Dodge, PhD

Principal Investigator

Oregon Health and Science Univeristy

Eligibility Criteria

Inclusion Criteria

Consent to MRI (if physically able to receive one)

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

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

Treatment Details

Interventions

• Internet-based Conversational Engagement (Behavioral Intervention)

Participant Groups

Group I: Conversational Engagement Experimental Treatment 1 Intervention

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.

Group II: Control Group Active Control 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Oregon Health & Science University Portland, OR

University of Michigan Ann Arbor, MI

Massachusetts General Hospital Boston, MA

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3066

Patients Recruited

13,430,000+

University of Michigan

Collaborator

Trials

1891

Patients Recruited

6,458,000+

Emory University

Collaborator

Trials

1735

Patients Recruited

2,605,000+

Oregon Health and Science University

Collaborator

Trials

1024

Patients Recruited

7,420,000+

National Institute on Aging (NIA)

Collaborator

Trials

1841

Patients Recruited

28,150,000+

Wayne State University

Collaborator

Trials

318

Patients Recruited

111,000+