NCT04085107

Brief Summary

This is a sequential mixed study to test the hypothesized models with seven hypotheses of the relationship between cognitive deficit (subject and objective) and neuropsychiatric symptoms (NPS) among persons with mild cognitive impairment (PwMCI). The study will also examine the psychometric properties of the Chinese version of Mild Behavioural Impairment -Checklist (MBI-C).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 5, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

March 29, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2020

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

9 months

First QC Date

September 5, 2019

Last Update Submit

January 19, 2021

Conditions

Keywords

mild cognitive impairmentneuropsychiatric symptomsinstrument validationcoping stylescognitive deficitneuroticismsocial support

Outcome Measures

Primary Outcomes (3)

  • Chinese Version of the Neuropsychiatric Inventory Questionnaire (NPI-Q)

    NPI-Q is a caregiver-administered instrument that assesses measure the frequency and severity of NPS among the participants.This instrument measures 12 domains including delusion, hallucination, anxiety, depression, euphoria, apathy, disinhibition, irritability and aberrant motor behaviour, sleep disturbance and appetite. The instrument will be completed by an informant to rate the frequency of NPS on a four-point scale (1 - sporadically, 4 - very often) and the severity of NPS on a three-point scale (1 - mild, 3 - severe).

    Baseline

  • Hong Kong Chinese version of Montreal Cognitive Assessment (HK-MoCA)

    This 12-item instrument will be used to measure cognitive functions including visuospatial functions, naming, verbal memory, abstraction, delay memory, calculation and orientation. Total score ranges from 0 to 30, with lower scores indicating more severe cognitive impairment.

    Baseline

  • Chinese version of Chinese version of Mild Behavioural Impairment -Checklist

    This 34-item questionnaire will be used to measure five domains of NPS, including decreased motivation, emotional dysregulation, impulse dyscontrol, social inappropriateness and abnormal perception or thought content. It involves closed-ended questions on the existence of symptoms followed by a 3-point Likert scale on their severity. Total scores of all domains range from 0 to 102, with higher scores indicating more NPS.

    Baseline

Secondary Outcomes (4)

  • Chinese version of Simplified Coping Scale Questionnaire (SCSQ)

    Baseline

  • Chinese version of Multidimensional Scale of Perceived Social Support (MSPSS-C)

    Baseline

  • Chinese version of the neuroticism subscale of NEO Personality Inventory (NEO-PI)

    Baseline

  • Rosenberg self-esteem scale (RSES)

    Baseline

Study Arms (1)

243 PwMCI

Behavioral: Face-to-face interviews

Interventions

243 PwMCI will receive two face-to-face interviews to complete two sets of questionnaires, of which 30 participants will be recruited attend a 1-hour semi-structured interview.

243 PwMCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Persons with mild cognitive impairment in Hong Kong

You may qualify if:

  • Aged 18 years old or above
  • Able to communicate in Cantonese
  • Diagnosis with MCI as defined by the following criteria:
  • Presence of significant cognitive complaints, as defined by more than three complaints on the Memory Inventory for Chinese (MIC), which is a 27-item instrument measuring subjective memory deficit
  • Abnormal objective cognitive performance defined as \< 1.5 standard deviations from age and education matched normal persons on Hong Kong Chinese version of Montreal Cognitive Assessment (HK-MoCA), which is a 12-item instrument measuring cognitive functions
  • Independence in daily living as evaluated through clinical interview
  • Both patients and one of their guardian or family members are consented to participate in the study

You may not qualify if:

  • With the confirmed diagnosis of any forms of dementia
  • With the confirmed diagnosis of psychiatric morbidities, or history with stroke, brain injury and other neurological conditions that may affect cognitive, behavioural and emotional functioning which may confound outcome measurement and limit their participation in the study
  • With hearing or visual impairment that may hinder participation in research activities
  • Current use of cognitive intervention or electromagnetic stimulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Cognitive DysfunctionBehavioral SymptomsCognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 11, 2019

Study Start

March 29, 2020

Primary Completion

December 29, 2020

Study Completion

December 29, 2020

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations