Cognitive Health Promotion Project in the Community

Ajou University School of Medicine

Status and phase: Completed; Phase 1

Conditions: Dietary Modification; Alteration of Cognitive Function

Treatments: Behavioral: Lifestyle Counseling Visit, Reward; Behavioral: Lifestyle Counseling Usual Care; Behavioral: Lifestyle Counseling Telephone, Month; Behavioral: Lifestyle Counseling Telephone, Bimonth; Behavioral: Lifestyle Counseling Visit, Bimonth

Study type: Interventional

Funder types: Other

Identifiers

NCT01012947

AjouU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,115 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,115 participants in 5 patient groups

Lifestyle Counseling Usual Care

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle Counseling Usual Care

Lifestyle Counseling Telephone, Bimonth

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle Counseling Telephone, Bimonth

Lifestyle Counseling Telephone, Month

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle Counseling Telephone, Month

Lifestyle Counseling Visit, Bimonth

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle Counseling Visit, Bimonth

Lifestyle Counseling Visit, Reward

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle Counseling Visit, Reward