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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Counseling Usual Care | Experimental | Usual care participants in the group A received no additional services. |
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| Lifestyle Counseling Telephone, Bimonth | Experimental | Participants in the group B received bimonthly telephonic care management based on manual. |
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| Lifestyle Counseling Telephone, Month | Experimental | Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B. |
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| Lifestyle Counseling Visit, Bimonth | Experimental | Participants in the group D received health educator-initiated visit counseling bimonthly. |
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| Lifestyle Counseling Visit, Reward | Experimental | Participants in the group E received health educator-initiated visit counseling bimonthly and reward. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Counseling Usual Care | Behavioral | Usual care participants in the group A received no additional services. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group | 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. | baseline and 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang Hyung Hong, MD PhD | Ajou University | Principal Investigator |
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Criteria for exclusion included severe visual or hearing impairment and a previous diagnosis of idiopathic Parkinson's disease, liver disease, alcoholism, or known terminal illness. Prior to initiating the study, we obtained a list of all senior citizen centers. A random number table was used to classify the intervention group.
The trial was conducted from August 2008 to December 2010 at a geriatric mental health community center in Suwon, south Korea. The center, which has been established since 2008 and has outreach sites throughout the districts, provides a range of social, health, educational, and recreational services for users of elderly groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lifestyle Counseling A,Usual Care | Usual care participants received no additional services. |
| FG001 | Lifestyle Counseling B, Telephone, Bimonthly | Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Lifestyle Counseling Telephone, Bimonth | Behavioral | Participants in the group B received bimonthly telephonic care management based on manual. |
|
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| 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. |
|
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| Lifestyle Counseling Visit, Bimonth | Behavioral | Participants in the group D received health educator-initiated visit counseling bimonthly. |
|
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| Lifestyle Counseling Visit, Reward | Behavioral | Participants in the group E received health educator-initiated visit counseling bimonthly and reward. |
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| FG002 | Lifestyle Counseling C, Telephone, Monthly | Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B. |
| FG003 | Lifestyle Counseling D, Visit, Bimonthly | Participants in the group D received health educator-initiated visit counseling bimonthly. |
| FG004 | Lifestyle Counseling E, Visit, Reward | Participants in the group E received health educator-initiated visit counseling bimonthly. Participants in the group E received reward. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lifestyle Counseling A,Usual Care | Usual care participants received no additional services. |
| BG001 | Lifestyle Counseling B, Telephone, Bimonthly | Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal. |
| BG002 | Lifestyle Counseling C, Telephone, Monthly | Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B. |
| BG003 | Lifestyle Counseling D, Visit, Bimonthly | Participants in the group D received health educator-initiated visit counseling bimonthly. |
| BG004 | Lifestyle Counseling E, Visit, Reward | Participants in the group E received health educator-initiated visit counseling bimonthly. Participants in the group E received reward. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group | 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. | The location of the survey was Suwon City, with a population of 1 million, located adjacent to Seoul, the nation's capital. The center, which has been established since 2008 and has outreach sites throughout the districts, provides a range of social, health, educational, and recreational services for users of elderly groups. | Posted | Mean | Standard Deviation | units on a scale | baseline and 18 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lifestyle Counseling A,Usual Care | Usual care participants received no additional services. | 0 | 212 | 0 | 212 | ||
| EG001 | Lifestyle Counseling B, Telephone, Bimonthly | Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal. | 0 | 215 | 0 | 215 | ||
| EG002 | Lifestyle Counseling C, Telephone, Monthly | Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B. | 0 | 241 | 0 | 241 | ||
| EG003 | Lifestyle Counseling D, Visit, Bimonthly | Participants in the group D received health educator-initiated visit counseling bimonthly. | 0 | 211 | 0 | 211 | ||
| EG004 | Lifestyle Counseling E, Visit, Reward | Participants in the group E received health educator-initiated visit counseling bimonthly. Participants in the group E received reward. | 0 | 236 | 0 | 236 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kang Soo Lee | Ajou University | 821087812077 | kpsimon@hanmail.net, antiaging@ajou.ac.kr |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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