Cognitive Health Promotion Project in the Community

NCT ID: NCT01012947

Last Updated: 2012-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 1115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-06-30

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.

Conditions

Alteration of Cognitive Function; Dietary Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Lifestyle Counseling Usual Care

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

Group Type: EXPERIMENTAL

Lifestyle Counseling Usual Care

Intervention Type: BEHAVIORAL

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

Lifestyle Counseling Telephone, Bimonth

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

Group Type: EXPERIMENTAL

Lifestyle Counseling Telephone, Bimonth

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Lifestyle Counseling Telephone, Month

Intervention Type: BEHAVIORAL

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

Lifestyle Counseling Visit, Bimonth

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

Group Type: EXPERIMENTAL

Lifestyle Counseling Visit, Bimonth

Intervention Type: BEHAVIORAL

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

Lifestyle Counseling Visit, Reward

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

Group Type: EXPERIMENTAL

Lifestyle Counseling Visit, Reward

Intervention Type: BEHAVIORAL

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

Interventions

Lifestyle Counseling Usual Care

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

Intervention Type: BEHAVIORAL

Lifestyle Counseling Telephone, Bimonth

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Lifestyle Counseling Visit, Bimonth

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

Intervention Type: BEHAVIORAL

Lifestyle Counseling Visit, Reward

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Group A usual care; Group B bimonthly telephone; Group C monthly telephone; Group D bimonthly visit; Group E bimonthly visit and reward

Eligibility 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Chang Hyung Hong

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chang Hyung Hong, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Ajou University

Other Identifiers

AjouU

Identifier Type: -

Identifier Source: org_study_id