Conversations as a Means to Delay the Onset of Alzheimer's Disease (conversation)
This study is currently recruiting participants.
Verified April 2012 by Oregon Health and Science University
Sponsor:
Oregon Health and Science University
Collaborator:
Information provided by (Responsible Party):
Hiroko H. Dodge, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01571427
First received: March 29, 2012
Last updated: April 4, 2012
Last verified: April 2012
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Purpose
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. the investigators will examine whether conversation-based cognitive stimulations have positive effects on general, and 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cognitive Impairment |
Behavioral: Active social engagement group Behavioral: Control group |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | Conversational Engagement as a Means to Delay Alzheimer's Disease Onset |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Oregon Health and Science University:
Primary Outcome Measures:
- Cognitive functions measured by neuropsychological tests [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]Pre-post trial changes in neuropsychological test results among the experimental group will be compared with pre-post changes among the control group
Secondary Outcome Measures:
- Psychological well-being [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]Pre-post changes in psychological measures (loneliness scale, depressive symptom, self-rated health, self-rated cognitive functions)
- Levels of social engagement [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]Pre-post changes in levels of social engagement (social engagement scores)
| Estimated Enrollment: | 90 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Control group
No active intervention
|
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
|
|
Active Comparator: Active soocial engagement group
Engage in 30 minutes conversation daily with interviewers using internet/webcam
|
Behavioral: 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
|
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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 >4 at screening
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571427
Contacts
| Contact: Molly Bowman, BS | (503) 494-6976 | bowmanmo@ohsu.edu |
Locations
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Molly Bowman 503-494-6976 bowmanmo@ohsu.edu | |
| Contact: Tracy Zitzelberger 503-494-7198 zitzelbe@ohsu.edu | |
| Principal Investigator: Hiroko H Dodge, PhD | |
| Sub-Investigator: Jeffrey A Kaye, MD | |
Sponsors and Collaborators
Oregon Health and Science University
More Information
Additional Information:
No publications provided
| Responsible Party: | Hiroko H. Dodge, Associate Professor of Neurology, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT01571427 History of Changes |
| Other Study ID Numbers: | socialengagementR01, R01AG033581 |
| Study First Received: | March 29, 2012 |
| Last Updated: | April 4, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Oregon Health and Science University:
|
Behavioral intervention Social engagement Conversational engagement |
Social network Cognitive Reserve Alzheimer's disease |
Additional relevant MeSH terms:
|
Alzheimer Disease Cognition Disorders Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 17, 2013