Internet-based Conversational Engagement Clinical Trial (I-CONECT)
Aging, Mild Cognitive Impairment

About this trial
This is an interventional prevention trial for Aging focused on measuring Behavioral intervention, social interaction, social isolation, loneliness, dementia, cognitive decline, MRI/fMRI, objective IADL assessment, speech characteristics (acoustic and linguistic), emotional well-being
Eligibility Criteria
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.
Sites / Locations
- Massachusetts General Hospital
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Conversational Engagement
Control Group
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.
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