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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01571427
First Posted: April 5, 2012
Last Update Posted: August 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Hiroko H. Dodge, Oregon Health and Science University
March 29, 2012
April 5, 2012
August 10, 2016
February 2012
September 2013   (Final data collection date for primary outcome measure)
Cognitive functions measured by neuropsychological tests [ Time Frame: up to 12 months ]
Pre-post trial changes in neuropsychological test results among the experimental group will be compared with pre-post changes among the control group
Same as current
Complete list of historical versions of study NCT01571427 on ClinicalTrials.gov Archive Site
  • Psychological well-being [ Time Frame: up to 12 months ]
    Pre-post changes in psychological measures (loneliness scale, isolation score, self-rated health), self-rated cognitive functions at post trial assessment.
  • Levels of social engagement [ Time Frame: up to 12 months ]
    Pre-post changes in levels of social engagement
  • Psychological well-being [ Time Frame: up to 12 months ]
    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 ]
    Pre-post changes in levels of social engagement (social engagement scores)
Not Provided
Not Provided
 
Conversations as a Means to Delay the Onset of Alzheimer's Disease
Conversational Engagement as a Means to Delay Alzheimer's Disease Onset
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.
Not Provided
Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Cognitive Impairment
  • 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
  • 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
  • Placebo Comparator: 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.
    Intervention: Behavioral: Control group
  • Active Comparator: Active soocial engagement group
    Active Social Engagement: Engage in 30 minutes conversation daily with interviewers using internet/webcam for 6 weeks
    Intervention: Behavioral: Active social engagement group
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
September 2013
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
70 Years and older   (Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01571427
socialengagementR01
R01AG033581 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Hiroko H. Dodge, Oregon Health and Science University
Oregon Health and Science University
National Institute on Aging (NIA)
Not Provided
Oregon Health and Science University
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP