An interventional study of Conversational Engagement in Aging and Mild Cognitive Impairment, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to participants aged 75 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention
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).
**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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 186 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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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
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
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
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
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
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
Intervention Efficacy for High Dose : Global Cognitive Function as Calculated From the Change From Baseline to Month 6
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.
Time frame: Change from baseline to month 6
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.
Time frame: 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. Scores reported are the mean change in score.
Time frame: 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. Scores are reported as a change score.
Time frame: Change from baseline to month 6
Recruitment was conducted between July 2018 and December 2020 from Portland, Oregon, and Detroit, Michigan; Potential subjects were identified via publicly available data; word-of-mouth referrals, and registries.
| Milestone | Conversational Engagement (MCI) | Control Group (MCI) | Control Group (NC) | Conversational Engagement (NC) |
|---|---|---|---|---|
| Started | 51 | 49 | 43 | 43 |
| Month 6 | 33 | 41 | 36 | 31 |
| Month 12 | 18 | 22 | 17 | 14 |
| Completed | 17 | 22 | 16 | 13 |
| Not completed | 34 | 27 | 27 | 30 |
| Withdrew: Withdrawal by subject | 34 | 27 | 27 | 30 |
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.
| units on a scale | Conversational Engagement (NC) | Control Group (NC) | Conversational Engagement (MCI) | Control Group (MCI) |
|---|---|---|---|---|
| Pre-pandemic cohort MoCA | 0.40 ± 2.27 | 0.07 ± 2.34 | 1.46 ± 2.11 | -0.44 ± 2.04 |
| Pre- and post-pandemic combined cohorts combined | -0.28 ± 2.30 | 0.31 ± 2.25 | 1.37 ± 3.04 | 0.22 ± 2.33 |
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.
| score on a scale | Conversational Engagement (NC) | Control Group (NC) | Conversational Engagement (MCI) | Control Group (MCI) |
|---|---|---|---|---|
| Intervention Efficacy for High Dose: Language-based Executive Function | 1.06 ± 4.24 | -0.46 ± 4.30 | -0.42 ± 3.96 | -0.59 ± 4.11 |
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. Scores reported are the mean change in score.
| units on a scale | Conversational Engagement (NC) | Control Group (NC) | Conversational Engagement (MCI) | Control Group (MCI) |
|---|---|---|---|---|
| Intervention Efficacy for High Dose: Learning Function | -.58 ± 3.58 | .63 ± 3.45 | .73 ± 3.51 | .95 ± 3.76 |
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. Scores are reported as a change score.
| units on a scale | Conversational Engagement (NC) | Control Group (NC) | Conversational Engagement (MCI) | Control Group (MCI) |
|---|---|---|---|---|
| Intervention Efficacy for High Dose: Memory Function | -.26 ± 3.88 | .74 ± 3.37 | 1.48 ± 4.47 | 1.08 ± 3.56 |
Collected over Adverse event data was collected over 2 years, from baseline to follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conversational Engagement (MCI) | 0/51 (0%) | 0/51 (0%) | 2/51 (3.9%) |
| Control Group (MCI) | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| Conversational Engagement (NC) | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Control Group(NC) | 0/43 (0%) | 0/43 (0%) | 1/43 (2.3%) |
| Event | Conversational Engagement (MCI) | Control Group (MCI) | Conversational Engagement (NC) | Control Group(NC) |
|---|---|---|---|---|
| Stomach acheGastrointestinal disorders | 1/51 | 0/49 | 0/43 | 1/43 |
| FatigueNervous system disorders | 1/51 | 0/49 | 0/43 | 0/43 |
| Age, Customized(years) | Conversational Engagement (NC) | Control Group (NC) | Conversational Engagement (MCI) | Control Group (MCI) | Total |
|---|---|---|---|---|---|
| Age | 79.6 ± 4 | 80 ± 3.7 | 81.9 ± 4.9 | 82.6 ± 4.9 | 81 ± 4.3 |
| Sex: Female, Male(Participants) | Conversational Engagement (NC) | Control Group (NC) | Conversational Engagement (MCI) | Control Group (MCI) | Total |
|---|---|---|---|---|---|
| Female | 30 | 35 | 34 | 31 | 130 |
| Male | 13 | 8 | 17 | 18 | 56 |
| Ethnicity (NIH/OMB)(Participants) | Conversational Engagement (NC) | Control Group (NC) | Conversational Engagement (MCI) | Control Group (MCI) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 43 | 43 | 51 | 49 | 186 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Conversational Engagement (NC) | Control Group (NC) | Conversational Engagement (MCI) | Control Group (MCI) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 5 | 7 | 13 | 10 | 35 |
| White | 37 | 36 | 37 | 39 | 149 |
| More than one race | 1 | 0 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
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Plan to share: Yes — All de-identified subject data will stored in a data repository at the conclusion of the research, and made available to approved investigators per a repository protocol.
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Massachusetts General Hospital