Mild Cognitive ImpairmentM&MresearchNCT02113345
The Relationship Between Metamemory and Memory in Old Age
A study testing Metamemory Cognitive Intervention in people with Mild Cognitive Impairment, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The purpose of this research is to explore the relationship of metamemory and memory of elders and to evaluate the effectiveness of a metamemory cognitive intervention on elders with mild cognitive impairment and low memory self-efficacy. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Metamemory Cognitive Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- Apr 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Study 1:
- Participants are Chinese elderly of age 65 or above and they speak Cantonese as their primary language. They are to be recruited from a convenience sample of clients who are without cognitive problems and are attending service in the Elderly Health Centres (EHC) of the Elderly Health Service of the Department of Health, Hong Kong Special Administrative Region Government (HKSARG).
- Study 2:
- In addition to the inclusion criteria of Study 1, EHC members with confirmed dementia, suspected dementia, and suspected MCI will also be invited to participate in Study 2. However, confirmed demented clients and suspected demented clients must show their capacity to appraise by passing Quality of Life Appraisal Inventory (CapQOL) (Wong, J.G.W.S. et al., 2005) before they are accepted to the Study. All clients are recruited upon consent.
- Study 3:
- Suspected MCI participants of Study 2 with below average memory self-efficacy assessed to have MCI (according to operational definition) will be invited and recruited to Study 3 upon consent. In the present research, MCI is defined operationally according to prior local studies and determined with reference to the educational level-adjusted cutoff scores of Chinese Mini Mental Status Examination (CMMSE) and Abbreviated version of Memory Inventory for the Chinese combined (Lam, L. C.W. \& et al., 2005; Lam, L.C.W. \& et al., 2008).
Who cannot join
- The presence of currently active medical conditions potentially affecting cognition e.g. vitamin B12 deficiency, hypothyroidism, chronic alcoholism, delirium, and active psychiatric disorders e.g. schizophrenia
- Other conditions that might affect cognitive competency e.g. aphasia, severe visual or hearing impairment.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to explore the relationship of metamemory and memory of elders and to evaluate the effectiveness of a metamemory cognitive intervention on elders with mild cognitive impairment and low memory self-efficacy.
Read the detailed description
There are 3 studies in the present research. Study 1 is a reliability and validity study of the Chinese Metamemory Scales. Study 2 is a cross-sectional study to explore the relationship between metamemory and memory of elders encountered in Hong Kong primary health care setting.Study 3 is an Effectiveness Study of Metamemory Cognitive Intervention on elders with mild cognitive impairment and low memory self-efficacy.
This research has the following aims and hypotheses:
Research Aims:
- To evaluate the reliability and validity of the Chinese Metamemory Scales
- To explore the relationship between metamemory and memory of elders
- To evaluate the effectiveness of a metamemory cognitive intervention on Mild Cognitive Impairment (MCI) elders who have low memory self-efficacy
Research Hypotheses:
Study 1: The Chinese Metamemory Scales will show acceptable psychometric properties.
Study 2: There is a positive correlation between metamemory (subjective memory) and memory (objective memory) and this relationship is mediated by stereotyped beliefs about memory ageing.
Study 3: Comparing to Control Group, the Intervention Group will yield the following expected results:
- There is an improvement in objective memory measures post-training.
- There is an improvement in subjective memory measures post-training.
- There is an improvement in mood measures post-training.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Metamemory Cognitive Intervention
- Keywords
- metamemory, memory, mild cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metamemory Cognitive InterventionBehavioural
Metamemory Cognitive Intervention
| Study group | Role | What they receive |
|---|---|---|
| lifestyle counseling | Experimental | Metamemory Cognitive Intervention Receives: Behavioral: Metamemory Cognitive Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Memory Measures
change from baseline in Hong Kong List Learning Test, 2nd Edition (HKLLT, Chan, A.S., 2006) for verbal episodic memory
Measured: Baseline, post-intervention at week 16
Objective Memory Measures
Change from baseline in Figure Recognition of Memory Assessment Scale (MAS, Williams, 1991) for visual episodic memory
Measured: Baseline, post-intervention at week 16
Objective Memory Measures
Change from baseline in Category Verbal Fluency Test (CVFT, categories to be chosen with reference to local studies by published by Chiu, H.F.K. et al., 1997 and Mok et al., 2004) for semantic memory
Measured: Baseline, post-intervention at week 16
Objective Memory Measures
Change from baseline in Digit Span and Visual Spatial Span from (MAS, Williams, 1991) for verbal and visual memory working memory
Measured: Baseline, post-intervention at week 16
Objective Memory Measures
Change from baseline in Event-based and Time-based Tasks for prospective memory (tasks to be developed with reference to the recommendations of Wilson, B.A. \& et al., 2008)
Measured: Baseline, post-intervention at week 16
Secondary outcomes (4)
Subjective Memory Measures
Change from baseline in the Chinese version of Memory Self-efficacy Scale (MSE, Frequency of Forgetting-10 Scale, Zelinski and Gilewski, 2004)
Measured: Baseline, post-intervention at week 16
Subjective Memory Measures
Change from baseline in Chinese versions of the Abbreviated version of Memory Inventory for the Chinese (AMIC, Lam, Linda, C. W. \& et al., 2005)
Measured: Baseline, post-intervention at week 16
Subjective Memory Measures
Change from baseline in Chinese versions of the Anxiety about Memory (AM, a subscale of the Memory Functioning Questionnaire, Gilewski, Zelinski \& Schaie, 1990, for Study 1 only)
Measured: Baseline, post-intervention at week 16
Subjective Memory Measures
Change from baseline in Chinese versions of the Stereotypes about Memory Aging (SMA, Fort \& Gana, 2009)
Measured: Baseline, post-intervention at week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debbie SK Chow, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113345
- Sponsor's protocol ID
- 082010Deb
- Acronym
- M&Mresearch
- Status last verified
- Apr 2014
- First submitted
- 12 Mar 2014
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Metamemory and Memory in Old Age
- ClinicalTrials.gov ID
- NCT02113345
- Acronym / sponsor ID
- M&Mresearch / 082010Deb
- Conditions
- Mild Cognitive Impairment
- Keywords
- metamemory, memory, mild cognitive impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to explore the relationship of metamemory and memory of elders and to evaluate the effectiveness of a metamemory cognitive intervention on elders with mild cognitive impairment and low memory self-efficacy.
Detailed description
There are 3 studies in the present research. Study 1 is a reliability and validity study of the Chinese Metamemory Scales. Study 2 is a cross-sectional study to explore the relationship between metamemory and memory of elders encountered in Hong Kong primary health care setting.Study 3 is an Effectiveness Study of Metamemory Cognitive Intervention on elders with mild cognitive impairment and low memory self-efficacy.
This research has the following aims and hypotheses:
Research Aims:
- To evaluate the reliability and validity of the Chinese Metamemory Scales
- To explore the relationship between metamemory and memory of elders
- To evaluate the effectiveness of a metamemory cognitive intervention on Mild Cognitive Impairment (MCI) elders who have low memory self-efficacy
Research Hypotheses:
Study 1: The Chinese Metamemory Scales will show acceptable psychometric properties.
Study 2: There is a positive correlation between metamemory (subjective memory) and memory (objective memory) and this relationship is mediated by stereotyped beliefs about memory ageing.
Study 3: Comparing to Control Group, the Intervention Group will yield the following expected results:
- There is an improvement in objective memory measures post-training.
- There is an improvement in subjective memory measures post-training.
- There is an improvement in mood measures post-training.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lifestyle counseling | Experimental | Behavioral: Metamemory Cognitive InterventionMetamemory Cognitive Intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Study 1:
- Participants are Chinese elderly of age 65 or above and they speak Cantonese as their primary language. They are to be recruited from a convenience sample of clients who are without cognitive problems and are attending service in the Elderly Health Centres (EHC) of the Elderly Health Service of the Department of Health, Hong Kong Special Administrative Region Government (HKSARG).
- Study 2:
- In addition to the inclusion criteria of Study 1, EHC members with confirmed dementia, suspected dementia, and suspected MCI will also be invited to participate in Study 2. However, confirmed demented clients and suspected demented clients must show their capacity to appraise by passing Quality of Life Appraisal Inventory (CapQOL) (Wong, J.G.W.S. et al., 2005) before they are accepted to the Study. All clients are recruited upon consent.
- Study 3:
Key exclusion criteria (2 listed)
- The presence of currently active medical conditions potentially affecting cognition e.g. vitamin B12 deficiency, hypothyroidism, chronic alcoholism, delirium, and active psychiatric disorders e.g. schizophrenia
- Other conditions that might affect cognitive competency e.g. aphasia, severe visual or hearing impairment.
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 |
|---|---|---|
| Metamemory Cognitive InterventionMetamemory Cognitive Intervention | Behavioural | lifestyle counseling |
Primary outcome
Objective Memory Measures
Time frame: Baseline, post-intervention at week 16
change from baseline in Hong Kong List Learning Test, 2nd Edition (HKLLT, Chan, A.S., 2006) for verbal episodic memory
Objective Memory Measures
Time frame: Baseline, post-intervention at week 16
Change from baseline in Figure Recognition of Memory Assessment Scale (MAS, Williams, 1991) for visual episodic memory
Objective Memory Measures
Time frame: Baseline, post-intervention at week 16
Change from baseline in Category Verbal Fluency Test (CVFT, categories to be chosen with reference to local studies by published by Chiu, H.F.K. et al., 1997 and Mok et al., 2004) for semantic memory
Objective Memory Measures
Time frame: Baseline, post-intervention at week 16
Change from baseline in Digit Span and Visual Spatial Span from (MAS, Williams, 1991) for verbal and visual memory working memory
Objective Memory Measures
Time frame: Baseline, post-intervention at week 16
Change from baseline in Event-based and Time-based Tasks for prospective memory (tasks to be developed with reference to the recommendations of Wilson, B.A. \& et al., 2008)
4 secondary outcomes
Subjective Memory Measures
Time frame: Baseline, post-intervention at week 16
Subjective Memory Measures
Time frame: Baseline, post-intervention at week 16
Subjective Memory Measures
Time frame: Baseline, post-intervention at week 16
Subjective Memory Measures
Time frame: Baseline, post-intervention at week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
Related trials for Mild Cognitive Impairment
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
Recruiting
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Parkinson Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
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.
Debbie SK Chow principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metamemory Cognitive Intervention in people with Mild Cognitive Impairment, run by The University of Hong Kong at 1 site in Hong Kong.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
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?
Objective Memory Measures (time frame: Baseline, post-intervention at week 16). The study lists 5 primary outcomes in all. 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 14 Apr 2014.