NCT02113345

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

1.9 years

First QC Date

March 12, 2014

Last Update Submit

April 9, 2014

Conditions

Keywords

metamemorymemorymild cognitive impairment

Outcome Measures

Primary Outcomes (5)

  • Objective Memory Measures

    change from baseline in Hong Kong List Learning Test, 2nd Edition (HKLLT, Chan, A.S., 2006) for verbal episodic memory

    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

    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

    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

    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)

    Baseline, post-intervention at week 16

Secondary Outcomes (4)

  • Subjective Memory Measures

    Baseline, post-intervention at week 16

  • Subjective Memory Measures

    Baseline, post-intervention at week 16

  • Subjective Memory Measures

    Baseline, post-intervention at week 16

  • Subjective Memory Measures

    Baseline, post-intervention at week 16

Study Arms (1)

lifestyle counseling

EXPERIMENTAL

Metamemory Cognitive Intervention

Behavioral: Metamemory Cognitive Intervention

Interventions

Metamemory Cognitive Intervention

lifestyle counseling

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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:
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Debbie SK Chow

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2014

First Posted

April 14, 2014

Study Start

April 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations