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
  Purpose

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.


Condition Intervention Phase
Alteration of Cognitive Function
Dietary Modification
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
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Cognitive Health Promotion Project in the Community

Further study details as provided by Ajou University School of Medicine:

Primary Outcome Measures:
  • 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.



Enrollment: 1115
Study Start Date: February 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle Counseling Usual Care
Usual care participants in the group A received no additional services.
Behavioral: Lifestyle Counseling Usual Care
Usual care participants in the group A received no additional services.
Other Name: Group A usual care
Experimental: Lifestyle Counseling Telephone, Bimonth
Participants in the group B received bimonthly telephonic care management based on manual.
Behavioral: Lifestyle Counseling Telephone, Bimonth
Participants in the group B received bimonthly telephonic care management based on manual.
Other Name: Group B bimonthly telephone
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.
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
Experimental: Lifestyle Counseling Visit, Bimonth
Participants in the group D received health educator-initiated visit counseling bimonthly.
Behavioral: Lifestyle Counseling Visit, Bimonth
Participants in the group D received health educator-initiated visit counseling bimonthly.
Other Name: Group D bimonthly visit
Experimental: Lifestyle Counseling Visit, Reward
Participants in the group E received health educator-initiated visit counseling bimonthly and reward.
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

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012947

Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Principal Investigator: Chang Hyung Hong, MD PhD Ajou University
  More Information

No publications provided

Responsible Party: Chang Hyung Hong, Associate Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01012947     History of Changes
Other Study ID Numbers: AjouU
Study First Received: November 12, 2009
Results First Received: August 18, 2011
Last Updated: January 19, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Ajou University School of Medicine:
MMSE
activity

ClinicalTrials.gov processed this record on October 21, 2014