Cognitive Health Promotion Project in the Community

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang Hyung Hong, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01012947
First received: November 12, 2009
Last updated: January 19, 2012
Last verified: January 2012
Results First Received: August 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   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
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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
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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  
Number of Participants  
[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


  More Information
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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.


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.  


Results Point of Contact:  
Name/Title: Dr. Kang Soo Lee
Organization: Ajou University
phone: 821087812077
e-mail: kpsimon@hanmail.net, antiaging@ajou.ac.kr


No publications provided


Responsible Party: Chang Hyung Hong, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01012947     History of Changes
Other Study ID Numbers: AjouU
Study First Received: November 12, 2009
Results First Received: August 18, 2011
Last Updated: January 19, 2012
Health Authority: Korea: Institutional Review Board