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Cognitive Health Promotion Project in the Community

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ClinicalTrials.gov Identifier: NCT01012947
Recruitment Status : Completed
First Posted : November 13, 2009
Results First Posted : February 24, 2012
Last Update Posted : February 24, 2012
Sponsor:
Information provided by (Responsible Party):
Chang Hyung Hong, Ajou University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions Alteration of Cognitive Function
Dietary Modification
Interventions 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
Enrollment 1115
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Lifestyle Counseling A,Usual Care Lifestyle Counseling B, Telephone, Bimonthly Lifestyle Counseling C, Telephone, Monthly Lifestyle Counseling D, Visit, Bimonthly Lifestyle Counseling E, Visit, Reward
Hide Arm/Group Description Usual care participants received no additional services. 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. Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B. Participants in the group D received health educator–initiated visit counseling bimonthly. Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.
Period Title: Overall Study
Started 212 215 241 211 236
Completed 81 80 111 93 94
Not Completed 131 135 130 118 142
Reason Not Completed
Lost to Follow-up             131             135             130             118             142
Arm/Group Title Lifestyle Counseling A,Usual Care Lifestyle Counseling B, Telephone, Bimonthly Lifestyle Counseling C, Telephone, Monthly Lifestyle Counseling D, Visit, Bimonthly Lifestyle Counseling E, Visit, Reward Total
Hide Arm/Group Description Usual care participants received no additional services. 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. Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B. Participants in the group D received health educator–initiated visit counseling bimonthly. Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward. Total of all reporting groups
Overall Number of Baseline Participants 212 215 241 211 236 1115
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 215 participants 241 participants 211 participants 236 participants 1115 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
212
 100.0%
215
 100.0%
241
 100.0%
211
 100.0%
236
 100.0%
1115
 100.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 212 participants 215 participants 241 participants 211 participants 236 participants 1115 participants
77.5  (1.9) 76.5  (2.9) 77.3  (1.7) 77.9  (3.7) 76.7  (2.1) 77.1  (2.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 212 participants 215 participants 241 participants 211 participants 236 participants 1115 participants
Female
157
  74.1%
174
  80.9%
188
  78.0%
170
  80.6%
172
  72.9%
861
  77.2%
Male
55
  25.9%
41
  19.1%
53
  22.0%
41
  19.4%
64
  27.1%
254
  22.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 212 participants 215 participants 241 participants 211 participants 236 participants 1115 participants
212 215 241 211 236 1115
1.Primary Outcome
Title Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group
Hide Description

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.

Time Frame baseline and 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lifestyle Counseling A,Usual Care Lifestyle Counseling B, Telephone, Bimonthly Lifestyle Counseling C, Telephone, Monthly Lifestyle Counseling D, Visit, Bimonthly Lifestyle Counseling E, Visit, Reward
Hide Arm/Group Description:
Usual care participants received no additional services.
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.
Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
Participants in the group D received health educator-initiated visit counseling bimonthly.
Participants in the group E received health educator-initiated visit counseling bimonthly. Participants in the group E received reward.
Overall Number of Participants Analyzed 212 215 241 211 236
Mean (Standard Deviation)
Unit of Measure: units on a scale
23.3  (2.3) 23.8  (2.1) 23.1  (1.0) 23.7  (1.4) 24.2  (0.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lifestyle Counseling A,Usual Care Lifestyle Counseling B, Telephone, Bimonthly Lifestyle Counseling C, Telephone, Monthly Lifestyle Counseling D, Visit, Bimonthly Lifestyle Counseling E, Visit, Reward
Hide Arm/Group Description Usual care participants received no additional services. 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. Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B. Participants in the group D received health educator–initiated visit counseling bimonthly. Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.
All-Cause Mortality
Lifestyle Counseling A,Usual Care Lifestyle Counseling B, Telephone, Bimonthly Lifestyle Counseling C, Telephone, Monthly Lifestyle Counseling D, Visit, Bimonthly Lifestyle Counseling E, Visit, Reward
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lifestyle Counseling A,Usual Care Lifestyle Counseling B, Telephone, Bimonthly Lifestyle Counseling C, Telephone, Monthly Lifestyle Counseling D, Visit, Bimonthly Lifestyle Counseling E, Visit, Reward
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/212 (0.00%)   0/215 (0.00%)   0/241 (0.00%)   0/211 (0.00%)   0/236 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lifestyle Counseling A,Usual Care Lifestyle Counseling B, Telephone, Bimonthly Lifestyle Counseling C, Telephone, Monthly Lifestyle Counseling D, Visit, Bimonthly Lifestyle Counseling E, Visit, Reward
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/212 (0.00%)   0/215 (0.00%)   0/241 (0.00%)   0/211 (0.00%)   0/236 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Kang Soo Lee
Organization: Ajou University
Phone: 821087812077
Responsible Party: Chang Hyung Hong, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01012947     History of Changes
Other Study ID Numbers: AjouU
First Submitted: November 12, 2009
First Posted: November 13, 2009
Results First Submitted: August 18, 2011
Results First Posted: February 24, 2012
Last Update Posted: February 24, 2012