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AzTrials

Mild Cognitive ImpairmentNCT04085107

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

An observational study of Mild Cognitive Impairment and Behavioral Symptoms, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Face-to-face interviews
How many people
152 participants
Where
1 siteHong Kong
Study dates
29 Mar 2020to 29 Dec 2020
How long will I take part?
6 Months
Phase
Observational
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Persons with mild cognitive impairment in Hong Kong

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

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).

Read the detailed description

The primary aim of this study is to test the hypothesized model that explores the moderating roles of neurotic personality, social support and coping style, as well as the mediating role of self-esteem in the relationship between cognitive deficit and NPS. This study will also examine the psychometric properties of the Chinese version of MBI-C.

Specifically, the four objectives of this study are as follows:

  1. To examine the relationship between cognitive deficit (subjective and objective) and NPS
  2. To examine the moderating roles of the neurotic trait (neuroticism) and coping resources (coping style and social support), as well as the mediating role of self-esteem in the relationship between cognitive deficit and NPS
  3. To explore the life experience of PwMCI that help to determine how these factors moderate/ mediate the relationship between cognitive deficit and NPS
  4. To examine the psychometric properties of the Chinese version of MBI-C among PwMCI in Hong Kong

This sequential mixed study will be conducted in two non-governmental organization in Hong Kong.

For the first and second objective, a descriptive, cross-sectional, correlational approach will be adopted to test the hypothesized models with seven hypotheses of the relationship between cognitive deficit (subject and objective) and NPS. The moderating roles of personality trait (neuroticism) and coping resources (coping styles and social support), as well as the mediating role of self-esteem in such a relationship, will also be explored.

For the third objective, semi-structured interviews will be adopted to explore the life experience of PwMCI, which help understanding how the proposed factors mediate or moderate the relationship between compromised abilities and NPS.

For the fourth objective, the psychometric properties of the Chinese version of MBI-C will be examined and reported. Internal consistency, 2-week test-retest reliability, factorial validity, concurrent validity and convergent validity will be assessed.

Being tested
Face-to-face interviews
Keywords
mild cognitive impairment, neuropsychiatric symptoms, instrument validation, coping styles, cognitive deficit, neuroticism, social support
Medical subject headings
Cognitive Dysfunction, Behavioral Symptoms, Cognition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Face-to-face interviewsBehavioural

    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.

Study groups in NCT04085107
Study groupRoleWhat they receive
243 PwMCINot described
Receives: Behavioral: Face-to-face interviews

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

Secondary outcomes (4)

  1. Chinese version of Simplified Coping Scale Questionnaire (SCSQ)

    This 20-item questionnaire will be adopted to evaluate their attitude towards life events, which could be divided into active (12 items) and passive (eight items) coping styles. Each item is rated at four-point Likert scale, with subscale score are summed from the items in each subscale. A higher subscale score indicates more frequent use of the coping style.

    Measured: Baseline

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

    This 12-item instrument measures the availability of support from family (4 items) and friends (8 items) on a seven-point Likert scale with total scores range from 12 to 48. Higher scores indicate a higher level of perceived social support.

    Measured: Baseline

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

    This 12-item neuroticism subscale will be adopted to measure neuroticism over manageability, comprehensibility and meaningfulness on a five-point Likert scale. Total scores range from 0 to 48, with higher scores indicating a more neurotic personality.

    Measured: Baseline

  4. Rosenberg self-esteem scale (RSES)

    The 10-item scale will be adopted to evaluate the sense of self-worth through five positive and five negative statements on a four-point Likert scale, all items are summed to total scores that range from 10 to 40, with a higher score indicating higher level of self-esteem.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2019
  2. Study start29 Mar 2020
  3. Primary completion29 Dec 2020
  4. Study completion29 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
152 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04085107
Sponsor's protocol ID
00000
Status last verified
Jan 2021
First submitted
5 Sep 2019
Last updated
20 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Cognitive Impairment and Behavioral Symptoms, run by Chinese 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 7 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 20 Jan 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Chinese Version of the Neuropsychiatric Inventory Questionnaire (NPI-Q) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04085107.

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 20 Jan 2021.

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