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

This study has been completed.
Sponsor:
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: September 21, 2013
Last verified: September 2013
  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:


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, isolation score, self-rated health), self-rated cognitive functions at post trial assessment.

  • Levels of social engagement [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    Pre-post changes in levels of social engagement


Enrollment: 96
Study Start Date: February 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Active Social Engagement: 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

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
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: September 21, 2013
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 April 15, 2014