Cognitive Health Promotion Project in the Community
1 other identifier
interventional
1,115
0 countries
N/A
Brief Summary
This study was based on baseline data derived from a large prospective study called the Suwon Project (SP), a cohort comprising random clustering samples of elderly people, all of whom are ethnic Koreans aged over 60 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2008
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 12, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
February 24, 2012
CompletedFebruary 24, 2012
January 1, 2012
2.3 years
November 12, 2009
August 18, 2011
January 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group
The mini-mental state examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It ranges from 0 to 30 points. The higher scores mean better outcome. It is also used to estimate the severity of cognitive impairment at a given point in time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. In the time span of about 10 minutes it samples various functions including arithmetic, memory and orientation.
baseline and 18 months
Study Arms (5)
Lifestyle Counseling Usual Care
EXPERIMENTALUsual care participants in the group A received no additional services.
Lifestyle Counseling Telephone, Bimonth
EXPERIMENTALParticipants in the group B received bimonthly telephonic care management based on manual.
Lifestyle Counseling Telephone, Month
EXPERIMENTALParticipants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
Lifestyle Counseling Visit, Bimonth
EXPERIMENTALParticipants in the group D received health educator-initiated visit counseling bimonthly.
Lifestyle Counseling Visit, Reward
EXPERIMENTALParticipants in the group E received health educator-initiated visit counseling bimonthly and reward.
Interventions
Usual care participants in the group A received no additional services.
Participants in the group B received bimonthly telephonic care management based on manual.
Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
Participants in the group D received health educator-initiated visit counseling bimonthly.
Participants in the group E received health educator-initiated visit counseling bimonthly and reward.
Eligibility Criteria
You may qualify if:
- more than 60 years old
You may not qualify if:
- those with a history of significant hearing or visual impairment that rendered participation in the interview difficult
- those with a history of neurological disorders (e.g., stroke, Parkinson's disease, or active epilepsy)
- those with psychiatric illness (e.g., schizophrenia, mental retardation, severe depression, or mania)
- those taking psychotropic medications, or those with significant alcohol and other substance abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kang Soo Lee
- Organization
- Ajou University
Study Officials
- PRINCIPAL INVESTIGATOR
Chang Hyung Hong, MD PhD
Ajou University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 12, 2009
First Posted
November 13, 2009
Study Start
February 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
February 24, 2012
Results First Posted
February 24, 2012
Record last verified: 2012-01