Trial Outcomes & Findings for Internet-based Conversational Engagement Clinical Trial (NCT NCT02871921)
NCT ID: NCT02871921
Last Updated: 2024-04-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
186 participants
Primary outcome timeframe
Change from baseline to month 6
Results posted on
2024-04-02
Participant Flow
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.
2 arms were pre-assigned: Conversational Engagement vs Control Group; and were later analyzed by Cognitive Status (Normal Cognition vs MCI).
Participant milestones
| Measure |
Conversational Engagement (MCI)
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.
Conversational Engagement: 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
|
Control Group (MCI)
Participants receive a phone call once per week that lasts approximately 10 minutes; interviewers ask brief questions to monitor participants' social activities and health conditions
|
Control Group (NC)
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
|
Conversational Engagement (NC)
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.
Conversational Engagement: 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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
49
|
43
|
43
|
|
Overall Study
Month 6
|
33
|
41
|
36
|
31
|
|
Overall Study
Month 12
|
18
|
22
|
17
|
14
|
|
Overall Study
COMPLETED
|
17
|
22
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
34
|
27
|
27
|
30
|
Reasons for withdrawal
| Measure |
Conversational Engagement (MCI)
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.
Conversational Engagement: 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
|
Control Group (MCI)
Participants receive a phone call once per week that lasts approximately 10 minutes; interviewers ask brief questions to monitor participants' social activities and health conditions
|
Control Group (NC)
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
|
Conversational Engagement (NC)
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.
Conversational Engagement: 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
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
34
|
27
|
27
|
30
|
Baseline Characteristics
Internet-based Conversational Engagement Clinical Trial
Baseline characteristics by cohort
| Measure |
Conversational Engagement (NC)
n=43 Participants
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.
Conversational Engagement: 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
|
Control Group (NC)
n=43 Participants
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
|
Conversational Engagement (MCI)
n=51 Participants
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.
Conversational Engagement: 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
|
Control Group (MCI)
n=49 Participants
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
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age
|
79.6 years
STANDARD_DEVIATION 4 • n=5 Participants
|
80 years
STANDARD_DEVIATION 3.7 • n=7 Participants
|
81.9 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
82.6 years
STANDARD_DEVIATION 4.9 • n=4 Participants
|
81 years
STANDARD_DEVIATION 4.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
186 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
149 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to month 6Population: The pre-pandemic cohort consists of participants who received in-person assessments both at baseline and M6 assessments using the MoCA full battery. During the COVID-19 pandemic, telephone MoCA was used. In the pre-and post-pandemic combined cohort, missing items in telephone MoCA were imputed using available test items. The final report shows model-based analysis results that controlled for confounders.
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.
Outcome measures
| Measure |
Conversational Engagement (NC)
n=31 Participants
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.
Conversational Engagement: 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
|
Control Group (NC)
n=35 Participants
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
|
Conversational Engagement (MCI)
n=33 Participants
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.
Conversational Engagement: 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
|
Control Group (MCI)
n=41 Participants
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
|
|---|---|---|---|---|
|
Intervention Efficacy for High Dose : Global Cognitive Function as Calculated From the Change From Baseline to Month 6
Pre-pandemic cohort MoCA
|
0.40 units on a scale
Standard Deviation 2.27
|
0.07 units on a scale
Standard Deviation 2.34
|
1.46 units on a scale
Standard Deviation 2.11
|
-0.44 units on a scale
Standard Deviation 2.04
|
|
Intervention Efficacy for High Dose : Global Cognitive Function as Calculated From the Change From Baseline to Month 6
Pre- and post-pandemic combined cohorts combined
|
-0.28 units on a scale
Standard Deviation 2.30
|
0.31 units on a scale
Standard Deviation 2.25
|
1.37 units on a scale
Standard Deviation 3.04
|
0.22 units on a scale
Standard Deviation 2.33
|
SECONDARY outcome
Timeframe: Change from baseline to month 6Population: Pre- and post-pandemic cohorts combined, participants with both baseline and M6 assessments
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.
Outcome measures
| Measure |
Conversational Engagement (NC)
n=31 Participants
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.
Conversational Engagement: 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
|
Control Group (NC)
n=35 Participants
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
|
Conversational Engagement (MCI)
n=33 Participants
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.
Conversational Engagement: 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
|
Control Group (MCI)
n=41 Participants
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
|
|---|---|---|---|---|
|
Intervention Efficacy for High Dose: Language-based Executive Function
|
1.06 score on a scale
Standard Deviation 4.24
|
-0.46 score on a scale
Standard Deviation 4.30
|
-0.42 score on a scale
Standard Deviation 3.96
|
-0.59 score on a scale
Standard Deviation 4.11
|
SECONDARY outcome
Timeframe: Change from baseline to month 6Population: Pre- and post-pandemic cohorts combined, participants with both baseline and M6 assessments
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.
Outcome measures
| Measure |
Conversational Engagement (NC)
n=31 Participants
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.
Conversational Engagement: 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
|
Control Group (NC)
n=35 Participants
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
|
Conversational Engagement (MCI)
n=33 Participants
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.
Conversational Engagement: 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
|
Control Group (MCI)
n=41 Participants
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
|
|---|---|---|---|---|
|
Intervention Efficacy for High Dose: Learning Function
|
-.58 units on a scale
Standard Deviation 3.58
|
.63 units on a scale
Standard Deviation 3.45
|
.73 units on a scale
Standard Deviation 3.51
|
.95 units on a scale
Standard Deviation 3.76
|
SECONDARY outcome
Timeframe: Change from baseline to month 6Population: Pre- and post-pandemic cohorts combined, participants with both baseline and M6 assessments
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.
Outcome measures
| Measure |
Conversational Engagement (NC)
n=31 Participants
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.
Conversational Engagement: 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
|
Control Group (NC)
n=35 Participants
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
|
Conversational Engagement (MCI)
n=33 Participants
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.
Conversational Engagement: 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
|
Control Group (MCI)
n=40 Participants
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
|
|---|---|---|---|---|
|
Intervention Efficacy for High Dose: Memory Function
|
-.26 units on a scale
Standard Deviation 3.88
|
.74 units on a scale
Standard Deviation 3.37
|
1.48 units on a scale
Standard Deviation 4.47
|
1.08 units on a scale
Standard Deviation 3.56
|
Adverse Events
Conversational Engagement (MCI)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control Group (MCI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conversational Engagement (NC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group(NC)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Conversational Engagement (MCI)
n=51 participants at risk
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.
Conversational Engagement: 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
|
Control Group (MCI)
n=49 participants at risk
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
|
Conversational Engagement (NC)
n=43 participants at risk
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.
Conversational Engagement: 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
|
Control Group(NC)
n=43 participants at risk
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
|
|---|---|---|---|---|
|
Nervous system disorders
Fatigue
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected over 2 years, from baseline to follow-up.
2 Arms were analyzed for Adverse Events (Conversational Engagement vs Control Group).
|
0.00%
0/49 • Adverse event data was collected over 2 years, from baseline to follow-up.
2 Arms were analyzed for Adverse Events (Conversational Engagement vs Control Group).
|
0.00%
0/43 • Adverse event data was collected over 2 years, from baseline to follow-up.
2 Arms were analyzed for Adverse Events (Conversational Engagement vs Control Group).
|
0.00%
0/43 • Adverse event data was collected over 2 years, from baseline to follow-up.
2 Arms were analyzed for Adverse Events (Conversational Engagement vs Control Group).
|
|
Gastrointestinal disorders
Stomach ache
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected over 2 years, from baseline to follow-up.
2 Arms were analyzed for Adverse Events (Conversational Engagement vs Control Group).
|
0.00%
0/49 • Adverse event data was collected over 2 years, from baseline to follow-up.
2 Arms were analyzed for Adverse Events (Conversational Engagement vs Control Group).
|
0.00%
0/43 • Adverse event data was collected over 2 years, from baseline to follow-up.
2 Arms were analyzed for Adverse Events (Conversational Engagement vs Control Group).
|
2.3%
1/43 • Number of events 1 • Adverse event data was collected over 2 years, from baseline to follow-up.
2 Arms were analyzed for Adverse Events (Conversational Engagement vs Control Group).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place