Trial Outcomes & Findings for Cognitive Health Promotion Project in the Community (NCT NCT01012947)

Last Updated: 2012-02-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

1115 participants

Primary outcome timeframe

baseline and 18 months

Results posted on

2012-02-24

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	212	215	241	211	236
Overall Study COMPLETED	81	80	111	93	94
Overall Study NOT COMPLETED	131	135	130	118	142

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	131	135	130	118	142

Baseline Characteristics

Cognitive Health Promotion Project in the Community

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifestyle Counseling A,Usual Care n=212 Participants Usual care participants received no additional services.	Lifestyle Counseling B, Telephone, Bimonthly n=215 Participants 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 n=241 Participants 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 n=211 Participants Participants in the group D received health educator-initiated visit counseling bimonthly.	Lifestyle Counseling E, Visit, Reward n=236 Participants Participants in the group E received health educator-initiated visit counseling bimonthly. Participants in the group E received reward.	Total n=1115 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical >=65 years	212 Participants n=5 Participants	215 Participants n=7 Participants	241 Participants n=5 Participants	211 Participants n=4 Participants	236 Participants n=21 Participants	1115 Participants n=8 Participants
Age Continuous	77.5 years STANDARD_DEVIATION 1.9 • n=5 Participants	76.5 years STANDARD_DEVIATION 2.9 • n=7 Participants	77.3 years STANDARD_DEVIATION 1.7 • n=5 Participants	77.9 years STANDARD_DEVIATION 3.7 • n=4 Participants	76.7 years STANDARD_DEVIATION 2.1 • n=21 Participants	77.1 years STANDARD_DEVIATION 2.5 • n=8 Participants
Sex: Female, Male Female	157 Participants n=5 Participants	174 Participants n=7 Participants	188 Participants n=5 Participants	170 Participants n=4 Participants	172 Participants n=21 Participants	861 Participants n=8 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	41 Participants n=7 Participants	53 Participants n=5 Participants	41 Participants n=4 Participants	64 Participants n=21 Participants	254 Participants n=8 Participants
Region of Enrollment Korea, Republic of	212 participants n=5 Participants	215 participants n=7 Participants	241 participants n=5 Participants	211 participants n=4 Participants	236 participants n=21 Participants	1115 participants n=8 Participants

PRIMARY outcome

Timeframe: baseline and 18 months

Population: 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.