Cognitive Health Promotion Project in the Community

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang Hyung Hong, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01012947
First received: November 12, 2009
Last updated: January 19, 2012
Last verified: January 2012

November 12, 2009
January 19, 2012
February 2008
June 2010   (final data collection date for primary outcome measure)
Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group [ Time Frame: baseline and 18 months ] [ Designated as safety issue: No ]

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.

  • mini mental state examination score [ Designated as safety issue: No ]
  • dementia prevalence [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01012947 on ClinicalTrials.gov Archive Site
Not Provided
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Cognitive Health Promotion Project in the Community
Cognitive Health Promotion Project in the Community

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Alteration of Cognitive Function
  • Dietary Modification
  • Behavioral: Lifestyle Counseling Usual Care
    Usual care participants in the group A received no additional services.
    Other Name: Group A usual care
  • Behavioral: Lifestyle Counseling Telephone, Bimonth
    Participants in the group B received bimonthly telephonic care management based on manual.
    Other Name: Group B bimonthly telephone
  • Behavioral: Lifestyle Counseling Telephone, Month
    Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
    Other Name: Group C monthly telephone
  • Behavioral: Lifestyle Counseling Visit, Bimonth
    Participants in the group D received health educator-initiated visit counseling bimonthly.
    Other Name: Group D bimonthly visit
  • Behavioral: Lifestyle Counseling Visit, Reward
    Participants in the group E received health educator-initiated visit counseling bimonthly and reward.
    Other Name: Group E bimonthly visit and reward
  • Experimental: Lifestyle Counseling Usual Care
    Usual care participants in the group A received no additional services.
    Intervention: Behavioral: Lifestyle Counseling Usual Care
  • Experimental: Lifestyle Counseling Telephone, Bimonth
    Participants in the group B received bimonthly telephonic care management based on manual.
    Intervention: Behavioral: Lifestyle Counseling Telephone, Bimonth
  • Experimental: Lifestyle Counseling Telephone, Month
    Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
    Intervention: Behavioral: Lifestyle Counseling Telephone, Month
  • Experimental: Lifestyle Counseling Visit, Bimonth
    Participants in the group D received health educator-initiated visit counseling bimonthly.
    Intervention: Behavioral: Lifestyle Counseling Visit, Bimonth
  • Experimental: Lifestyle Counseling Visit, Reward
    Participants in the group E received health educator-initiated visit counseling bimonthly and reward.
    Intervention: Behavioral: Lifestyle Counseling Visit, Reward
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1115
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01012947
AjouU
Yes
Chang Hyung Hong, Ajou University School of Medicine
Ajou University School of Medicine
Not Provided
Principal Investigator: Chang Hyung Hong, MD PhD Ajou University
Ajou University School of Medicine
January 2012

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