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Completed

NCT Number: NCT01012947

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.

Completed

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle Counseling Usual Care

Behavioral

Usual care participants in the group A received no additional services.

Other names: Group A usual care

Lifestyle Counseling Telephone, Bimonth

Behavioral

Participants in the group B received bimonthly telephonic care management based on manual.

Other names: Group B bimonthly telephone

Lifestyle Counseling Telephone, Month

Behavioral

Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.

Other names: Group C monthly telephone

Lifestyle Counseling Visit, Bimonth

Behavioral

Participants in the group D received health educator-initiated visit counseling bimonthly.

Other names: Group D bimonthly visit

Lifestyle Counseling Visit, Reward

Behavioral

Participants in the group E received health educator-initiated visit counseling bimonthly and reward.

Other names: Group E bimonthly visit and reward

Primary outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 13, 2009
Registry last updated
Feb 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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