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Cognitive Health Promotion Project in the Community

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Lifestyle Counseling A,Usual Care Usual care participants received no additional services.
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.
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.
Lifestyle Counseling D, Visit, Bimonthly Participants in the group D received health educator–initiated visit counseling bimonthly.
Lifestyle Counseling E, Visit, Reward Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.

Participant Flow:   Overall Study
    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
STARTED   212   215   241   211   236 
COMPLETED   81   80   111   93   94 
NOT COMPLETED   131   135   130   118   142 
Lost to Follow-up                131                135                130                118                142 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lifestyle Counseling A,Usual Care Usual care participants received no additional services.
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.
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.
Lifestyle Counseling D, Visit, Bimonthly Participants in the group D received health educator–initiated visit counseling bimonthly.
Lifestyle Counseling E, Visit, Reward Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.
Total Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 212   215   241   211   236   1115 
Age 
[Units: Participants]
           
<=18 years   0   0   0   0   0   0 
Between 18 and 65 years   0   0   0   0   0   0 
>=65 years   212   215   241   211   236   1115 
Age 
[Units: Years]
Mean (Standard Deviation)
 77.5  (1.9)   76.5  (2.9)   77.3  (1.7)   77.9  (3.7)   76.7  (2.1)   77.1  (2.5) 
Gender 
[Units: Participants]
           
Female   157   174   188   170   172   861 
Male   55   41   53   41   64   254 
Region of Enrollment 
[Units: Participants]
           
Korea, Republic of   212   215   241   211   236   1115 


  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: kpsimon@hanmail.net, antiaging@ajou.ac.kr



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