NCT04723667

Brief Summary

This study aims to evaluate the effects of a 13-week empowerment-based psycho-behavioral program to improve neuropsychiatric symptoms, cognitive functions, and health-related quality of life among persons with mild cognitive impairment. Its feasibility will be first evaluated in a pilot study and subsequently in a randomized controlled trial (RCT)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

September 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2022

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

December 14, 2020

Last Update Submit

May 17, 2023

Conditions

Mild Cognitive Impairment

Keywords

neuropsychiatric symptomsrandomized controlled trial

Outcome Measures

Primary Outcomes (4)

  • Mild Behavioral Impairment - Checklist (MBI-C)

    Mild Behavioral Impairment - Checklist (MBI-C), 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.

    17 weeks

  • Kessler Psychological Distress Scale (K10)

    Kessler Psychological Distress Scale (K10), this 10-item instrument will be used to measure the level of non-specific psychological distress, primarily anxiety and depression, over the past month on a '1-5' 5-point Likert scale.

    17 weeks

  • Apathy Evaluation Scale (AES-S)

    Apathy Evaluation Scale (AES-S), this 18-item instrument will be used to measure apathy over the past four weeks on a '1-4' 4-point Likert scale.

    17 weeks

  • Geriatric Depression Scale - Short Form (GDS-SF)

    Geriatric Depression Scale - Short Form (GDS-SF), this 15-item instrument will be used to measure depression.

    17 weeks

Secondary Outcomes (3)

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

    17 weeks

  • Memory Inventory in Chinese (MIC)

    17 weeks

  • Hong Kong Short Form -12 (HK-SF12)

    17 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

13-week multimodal intervention

Behavioral: 13-week multimodal intervention

Active control

ACTIVE COMPARATOR

5-week health education programme

Behavioral: 5-week health education programme

Interventions

13-week multimodal interventionBEHAVIORAL

The experimental intervention was a 13-week multimodal intervention consists of five-weekly, 90-minute, face-to-face sessions to be delivered in a group format (six to eight participants per group), followed by two weekly and three biweekly telephone follow-ups. The five face-to-face sessions covered brain health information, booster memory power, reducing stressors, optimizing strength and active lifestyle engagement.

Intervention
5-week health education programmeBEHAVIORAL

The health education program consisted of three topics (fall prevention, oral care and home hygiene), with two tele-booster follow up

Active control

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 50 years old or above
  • Able to communicate in Cantonese
  • Diagnosis with MCI as defined by the following criteria:
  • I. Presence of significant cognitive complaints as reflected by self-report II. 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, more details are outlined under the session of outcome measures III. Independence in daily living as evaluated through clinical interviews

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, behavioral, 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 any cognitive intervention or electromagnetic stimulation that confound cognitive outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rose Lin

Hong Kong, Hong Kong

Location

University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Lin RSY, Yu DSF, Pui Hing Chau P, Li PWC. An empowerment-psycho-behavioral program on neuropsychiatric symptoms in persons with mild cognitive impairment: Study protocol of a randomized controlled trial. J Adv Nurs. 2021 Aug;77(8):3507-3517. doi: 10.1111/jan.14871. Epub 2021 Apr 28.

    PMID: 33909293DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Rose Lin

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessors were blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study aims to evaluate the effects of a 13-week empowerment-based psycho-behavioral program to improve neuropsychiatric symptoms, cognitive functions, and health-related quality of life among persons with mild cognitive impairment. A feasibility pilot study will be first evaluated in a pilot study among 30 participants with MCI and subsequently a full-scale randomized controlled trial will be conducted.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

December 14, 2020

First Posted

January 26, 2021

Study Start

September 1, 2020

Primary Completion

July 18, 2021

Study Completion

June 10, 2022

Last Updated

May 19, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Anonymity will be reassured by subject codes without identifiers of the participants. All the data collected will be stored in secure place and can only be accessed by research team members. All the data will be kept for five years and will be destroyed upon the completion of the study as to protect participants' confidentiality.

Locations

HK(2)