Alteration of Cognitive FunctionPhase 1NCT01012947
Cognitive Health Promotion Project in the Community
A Phase 1 study testing Lifestyle Counseling Telephone, Bimonth, Lifestyle Counseling Telephone, Month and Lifestyle Counseling Visit, Bimonth in people with Alteration of Cognitive Function and Dietary Modification, run by Ajou University School of Medicine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alteration of Cognitive Function, Dietary Modification
- What is being tested?
- Lifestyle Counseling Telephone, Bimonth, Lifestyle Counseling Telephone, Month and Lifestyle Counseling Visit, Bimonth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,115 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Jun 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- more than 60 years old
Who cannot join
- those with a history of significant hearing or visual impairment that rendered participation in the interview difficult
- those with a history of neurological disorders (e.g., stroke, Parkinson's disease, or active epilepsy)
- those with psychiatric illness (e.g., schizophrenia, mental retardation, severe depression, or mania)
- those taking psychotropic medications, or those with significant alcohol and other substance abuse.
About this study
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.
Read the detailed description
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.
- Being tested
- Lifestyle Counseling Usual Care, Lifestyle Counseling Telephone, Bimonth, Lifestyle Counseling Telephone, Month, Lifestyle Counseling Visit, Bimonth, Lifestyle Counseling Visit, Reward
- Keywords
- MMSE, activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Counseling Usual CareBehavioural
Also called Group A usual care
Usual care participants in the group A received no additional services.
Lifestyle Counseling Telephone, BimonthBehavioural
Also called Group B bimonthly telephone
Participants in the group B received bimonthly telephonic care management based on manual.
Lifestyle Counseling Telephone, MonthBehavioural
Also called Group C monthly telephone
Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
Lifestyle Counseling Visit, BimonthBehavioural
Also called Group D bimonthly visit
Participants in the group D received health educator-initiated visit counseling bimonthly.
Lifestyle Counseling Visit, RewardBehavioural
Also called Group E bimonthly visit and reward
Participants in the group E received health educator-initiated visit counseling bimonthly and reward.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Counseling Usual Care | Experimental | Usual care participants in the group A received no additional services. Receives: Behavioral: Lifestyle Counseling Usual Care |
| Lifestyle Counseling Telephone, Bimonth | Experimental | Participants in the group B received bimonthly telephonic care management based on manual. Receives: Behavioral: Lifestyle Counseling Telephone, Bimonth |
| 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. Receives: Behavioral: Lifestyle Counseling Telephone, Month |
| Lifestyle Counseling Visit, Bimonth | Experimental | Participants in the group D received health educator-initiated visit counseling bimonthly. Receives: Behavioral: Lifestyle Counseling Visit, Bimonth |
| Lifestyle Counseling Visit, Reward | Experimental | Participants in the group E received health educator-initiated visit counseling bimonthly and reward. Receives: Behavioral: Lifestyle Counseling Visit, Reward |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startFeb 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alteration of Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Hyung Hong, Ajou University School of Medicine
- Investigators
- Chang Hyung Hong, MD PhD, Principal investigator, Ajou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012947
- Sponsor's protocol ID
- AjouU
- Status last verified
- Jan 2012
- First submitted
- 12 Nov 2009
- Last updated
- 24 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Health Promotion Project in the Community
- ClinicalTrials.gov ID
- NCT01012947
- Acronym / sponsor ID
- AjouU
- Keywords
- MMSE, activity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,115 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Posted 24 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Counseling Usual Care | Experimental | Behavioral: Lifestyle Counseling Usual CareUsual care participants in the group A received no additional services. |
| Lifestyle Counseling Telephone, Bimonth | Experimental | Behavioral: Lifestyle Counseling Telephone, BimonthParticipants in the group B received bimonthly telephonic care management based on manual. |
| Lifestyle Counseling Telephone, Month | Experimental | Behavioral: Lifestyle Counseling Telephone, MonthParticipants in the group C received monthly the same telephonic care management and educational materials as those in the group B. |
| Lifestyle Counseling Visit, Bimonth | Experimental | Behavioral: Lifestyle Counseling Visit, BimonthParticipants in the group D received health educator-initiated visit counseling bimonthly. |
| Lifestyle Counseling Visit, Reward | Experimental | Behavioral: Lifestyle Counseling Visit, RewardParticipants in the group E received health educator-initiated visit counseling bimonthly and reward. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- more than 60 years old
Key exclusion criteria (4 listed)
- those with a history of significant hearing or visual impairment that rendered participation in the interview difficult
- those with a history of neurological disorders (e.g., stroke, Parkinson's disease, or active epilepsy)
- those with psychiatric illness (e.g., schizophrenia, mental retardation, severe depression, or mania)
- those taking psychotropic medications, or those with significant alcohol and other substance abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Counseling Usual CareAlso: Group A usual careUsual care participants in the group A received no additional services. | Behavioural | Lifestyle Counseling Usual Care |
| Lifestyle Counseling Telephone, BimonthAlso: Group B bimonthly telephoneParticipants in the group B received bimonthly telephonic care management based on manual. | Behavioural | Lifestyle Counseling Telephone, Bimonth |
| Lifestyle Counseling Telephone, MonthAlso: Group C monthly telephoneParticipants in the group C received monthly the same telephonic care management and educational materials as those in the group B. | Behavioural | Lifestyle Counseling Telephone, Month |
| Lifestyle Counseling Visit, BimonthAlso: Group D bimonthly visitParticipants in the group D received health educator-initiated visit counseling bimonthly. | Behavioural | Lifestyle Counseling Visit, Bimonth |
| Lifestyle Counseling Visit, RewardAlso: Group E bimonthly visit and rewardParticipants in the group E received health educator-initiated visit counseling bimonthly and reward. | Behavioural | Lifestyle Counseling Visit, Reward |
Primary outcome
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Hyung Hong, MD PhD principal investigator
Ajou University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lifestyle Counseling Telephone, Bimonth, Lifestyle Counseling Telephone, Month and Lifestyle Counseling Visit, Bimonth in people with Alteration of Cognitive Function and Dietary Modification, run by Ajou University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2012.