Conversations as a Means to Delay the Onset of Alzheimer's Disease

NCT ID: NCT01571427

Last Updated: 2020-02-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-09-30

Brief Summary

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Past epidemiological studies have demonstrated that larger social networks, or more frequent social interactions, could have potential protective effects on the incidence of Alzheimer's Disease (AD). However, in those studies, indicators of social interactions were often broad, and included distinct elements that affected cognition and overall health. This project will examine whether conversation-based cognitive stimulation has positive effects on domain-specific cognitive functions among the elderly. Face-to-face communication will be conducted through the use of personal computers, webcams, and user-friendly simple interactive Internet programs to allow participants to have social engagement while staying at their home and also for the cost effective execution of the study.

Detailed Description

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Participants are randomized into the control group (weekly 10 minutes phone check-in only) or experimental group (30 minutes daily video chat with standardized/trained conversational staff). User-friendly equipment and internet are provided.

Conditions

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Mild Cognitive Impairment Cognitive Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental and control groups. The experimental group will have 30 minutes daily (5 times per week) video chat with standardized conversational staff for 6 weeks, while the control group will have phone check-in once per week for 10 minutes for increasing retention. Both groups will complete weekly web-based heath form using PC and internet.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Investigators and assessors are blind to the group assignment

Study Groups

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Control group

No daily conversational sessions with interviewers using webcam/internet. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel.

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type BEHAVIORAL

No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device. Participants will be reassessed at the 3rd and 6th month after completion of the intervention.

Active social engagement group

Engage in 30 minutes video chat daily (5 times per week, except weekend) with interviewers for 6 weeks. Weekly web-based heath form must be submitted using internet/PC. If not, subjects receive prompts from study personnel.

Group Type ACTIVE_COMPARATOR

Active social engagement group

Intervention Type BEHAVIORAL

Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention

Interventions

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Active social engagement group

Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention

Intervention Type BEHAVIORAL

Control group

No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device. Participants will be reassessed at the 3rd and 6th month after completion of the intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Non-demented participants
* Willing to participate in daily conversation using internet/webcam with interviewers for 6 weeks
* Willing to monitor daily conversational amount using a digital recording device
* Willing informant who has frequent contact with the participant

Exclusion Criteria

* have major illness or disabilities which interfere with interacting using the audio/video technology
* diagnosed as dementia
* MMSE \< 24 at screening
* Geriatric Depression Scale (15 items) \>4 at screening
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Hiroko H. Dodge

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Dodge HH, Katsumata Y, Zhu J, Mattek N, Bowman M, Gregor M, Wild K, Kaye JA. Characteristics associated with willingness to participate in a randomized controlled behavioral clinical trial using home-based personal computers and a webcam. Trials. 2014 Dec 23;15:508. doi: 10.1186/1745-6215-15-508.

Reference Type BACKGROUND
PMID: 25539637 (View on PubMed)

Asgari M, Kaye J, Dodge H. Predicting mild cognitive impairment from spontaneous spoken utterances. Alzheimers Dement (N Y). 2017 Feb 27;3(2):219-228. doi: 10.1016/j.trci.2017.01.006. eCollection 2017 Jun.

Reference Type BACKGROUND
PMID: 29067328 (View on PubMed)

Dodge HH, Mattek N, Gregor M, Bowman M, Seelye A, Ybarra O, Asgari M, Kaye JA. Social Markers of Mild Cognitive Impairment: Proportion of Word Counts in Free Conversational Speech. Curr Alzheimer Res. 2015;12(6):513-9. doi: 10.2174/1567205012666150530201917.

Reference Type BACKGROUND
PMID: 26027814 (View on PubMed)

Dodge HH, Zhu J, Mattek N, Bowman M, Ybarra O, Wild K, Loewenstein DA, Kaye JA. Web-enabled Conversational Interactions as a Means to Improve Cognitive Functions: Results of a 6-Week Randomized Controlled Trial. Alzheimers Dement (N Y). 2015 May;1(1):1-12. doi: 10.1016/j.trci.2015.01.001.

Reference Type RESULT
PMID: 26203461 (View on PubMed)

Cerino ES, Hooker K, Goodrich E, Dodge HH. Personality Moderates Intervention Effects on Cognitive Function: A 6-Week Conversation-Based Intervention. Gerontologist. 2020 Jul 15;60(5):958-967. doi: 10.1093/geront/gnz063.

Reference Type RESULT
PMID: 31112605 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4507295/

Web-enabled conversational interactions as a means to improve cognitive functions: Results of a 6-week randomized controlled trial

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4307639/

Characteristics associated with willingness to participate in a randomized controlled behavioral clinical trial using home-based personal computers and a webcam

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5651423/

Predicting mild cognitive impairment from spontaneous spoken utterances

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4526336/

Social markers of mild cognitive impairment: Proportion of word counts in free conversational speech

Other Identifiers

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R01AG033581

Identifier Type: NIH

Identifier Source: secondary_id

View Link

socialengagementR01

Identifier Type: -

Identifier Source: org_study_id

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