Internet-based Conversational Engagement Clinical Trial



Status:Recruiting
Conditions:Cognitive Studies, Cognitive Studies, Healthy Studies
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:75 - Any
Updated:4/6/2019
Start Date:June 1, 2018
End Date:October 31, 2022
Contact:Study Coordinator
Email:I-CONECT@ohsu.edu
Phone:503-494-9043

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At each site (OHSU & UM), 160 socially isolated adults 75+ years old will be recruited from
the community and randomized to either the Video Chat Group or the Control Group. Those 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). 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, 6 months, and 12 months.
All participants at OHSU will have their medication compliance tracked using an electronic
medication monitoring device and all participants at both OHSU and UM will have MRIs at
Baseline and 6 months, if they are able to safely receive MRIs. All participants at both
sites will contribute saliva for genetic testing, and all video chat and neuropsychological
assessment sessions will be recorded for speech and language analysis.


Inclusion Criteria:

1. Age 75 or older

2. Consent to MRI (if physically able to receive one) and APOE4 genotype assessment

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

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, frontotemporal 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.
We found this trial at
2
sites
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Benjamin Hampstead, PhD
Phone: 734-647-2676
University of Michigan The University of Michigan was founded in 1817 as one of the...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Hiroko H Dodge, PhD
Phone: 503-494-9043
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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