The Moderating Roles of Social Support, Coping Resources and Personality and Mediating Role of Self-esteem on the Impact of Cognitive Deficit on Neuropsychiatric Symptoms Among Persons With Mild Cognitive Impairment: A Mixed-method Sequential Explanatory Design
1 other identifier
observational
152
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
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
CompletedFirst Posted
Study publicly available on registry
September 11, 2019
CompletedStudy Start
First participant enrolled
March 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2020
CompletedJanuary 20, 2021
January 1, 2021
9 months
September 5, 2019
January 19, 2021
Conditions
Keywords
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
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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