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Cognitive Health Promotion Project in the Community

Phase 1
Completed
Conditions
Alteration of Cognitive Function
Dietary Modification
Interventions
Behavioral: Lifestyle Counseling Usual Care
Behavioral: Lifestyle Counseling Telephone, Bimonth
Behavioral: Lifestyle Counseling Telephone, Month
Behavioral: Lifestyle Counseling Visit, Bimonth
Behavioral: Lifestyle Counseling Visit, Reward
Registration Number
NCT01012947
Lead Sponsor
Ajou University School of Medicine
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.

Detailed Description

There is growing evidence supporting the protective effect of health behaviors against cognitive decline and dementia in older persons. With this increasing evidence and a better understanding of the underlying mechanisms, lifestyle modification is likely to be increasingly promoted as a convincing strategy for maintaining cognitive health in later life.

The study protocol included cognitive screening through the Korean version of the Mini-Mental State Examination (K-MMSE), which has been validated for the Korean-speaking population ({YW, 1997 #88}Kang YW et al., 1997), recording of the subject's medical history. A Korean study in the community defined the cut-off point of K-MMSE score during the screening of dementia as 17/18 points; the sensitivity and specificity of the findings were 91% and 86%, respectively ({YW, 1997 #88}Kim et al., 2003). Based on these results, we defined cognitive impairment (CI) as the group that had a K-MMSE score lower than 17, and not cognitive impairment (NCI) was defined as the group that had a K-MMSE score higher than 18.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1115
Inclusion Criteria
  • more than 60 years old
Exclusion Criteria
  • 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Lifestyle Counseling Usual CareLifestyle Counseling Usual CareUsual care participants in the group A received no additional services.
Lifestyle Counseling Telephone, BimonthLifestyle Counseling Telephone, BimonthParticipants in the group B received bimonthly telephonic care management based on manual.
Lifestyle Counseling Telephone, MonthLifestyle Counseling Telephone, MonthParticipants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
Lifestyle Counseling Visit, BimonthLifestyle Counseling Visit, BimonthParticipants in the group D received health educator-initiated visit counseling bimonthly.
Lifestyle Counseling Visit, RewardLifestyle Counseling Visit, RewardParticipants in the group E received health educator-initiated visit counseling bimonthly and reward.
Primary Outcome Measures
NameTimeMethod
Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Groupbaseline and 18 months

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.

Secondary Outcome Measures
NameTimeMethod
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