Machine Learning Enabled Management of Behavioural and Psychological Symptoms of Dementia Intervention for Dementia Caregivers

May 14, 2026 updated by: Chou Kee Lee, Education University of Hong Kong

Developing and Testing a Machine Learning Enabled Management of Behavioural and Psychological Symptoms of Dementia Intervention for Dementia Caregivers: A Hybrid Experimental Design Study

Develop and test a machine learning enabled management of behavioural and psychological symptoms of dementia intervention for dementia caregivers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
550

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • aged 18 above
  • family caregiver of an individual with a confirmed medical diagnosis of any type of dementia who has been residing in the community
  • having been providing care for ADLs and IADLs for at least 20 hours per week for at least one year prior to recruitment
  • have a smartphone
  • have mild to moderate stress (the 14-item Chinese version Perceived Stress Scale).

Exclusion Criteria:

  • having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention in the 6 months prior to recruitment
  • having acute psychiatric and medical comorbidities that are potentially life-threatening (e.g. suicidal ideation) or that limit the caregivers' participation or adherence (e.g. acute psychosis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active control
Behavioral: Active Control
No APP based coaching, no human coaching, no rerandomization, no MRT
Experimental: App & Human Coaching + Continue Intervention
First-line of coaching: App + Human Coaching Responder
Behavioral: Behavioral: Continue
Continue with existing intervention plan
Experimental: App & Human Coaching + Increase intensity in human coaching
First-line of coaching: App + Human Coaching Non-Responder
Behavioral: Behavioral: Enhance human coaching
Increase intensity of human coaching
Experimental: App & Human Coaching + Booster
First-line of coaching: App + Human Coaching Non-Responder
Behavioral: Behavioral: Booster
Add a booster session
Experimental: App Coaching + Continue Intervention
First-line of coaching: App Coaching Responder
Behavioral: Behavioral: Continue
Continue with existing intervention plan
Experimental: App Coaching + Increase intensity in human coaching
First-line of coaching: App Coaching Non-Responder
Behavioral: Behavioral: Enhance human coaching
Increase intensity of human coaching
Experimental: App Coaching + Booster
First-line of coaching: App Coaching Non-Responder
Behavioral: Behavioral: Booster
Add a booster session
Experimental: Human Coaching + Continue Intervention
First-line of coaching: Human Coaching Responder
Behavioral: Behavioral: Continue
Continue with existing intervention plan
Experimental: Human Coaching + Increase intensity in human coaching
First-line of coaching: Human Coaching Non-Responder
Behavioral: Behavioral: Enhance human coaching
Increase intensity of human coaching
Experimental: Human Coaching + Booster
First-line of coaching: Human Coaching Non-Responder
Behavioral: Behavioral: Booster
Add a booster session
Experimental: No Coaching + Continue Intervention
First-line of coaching: No Coaching Responder
Behavioral: Behavioral: Continue
Continue with existing intervention plan
Experimental: No Coaching + Increase intensity in human coaching
First-line of coaching: No Coaching Non-Responder
Behavioral: Behavioral: Enhance human coaching
Increase intensity of human coaching
Experimental: No Coaching + Booster
First-line of coaching: No Coaching Non-Responder
Behavioral: Behavioral: Booster
Add a booster session

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stress
Time Frame: Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
10-item Perceived Stress Scale; each item will be rated from 0=Never to 4=Very often. Total scores range from 0 to 40.
Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Patient Health Questionnaire-9; Each item will be rated from 0=Not at all to 3=nearly everyday. Total scores range from 0 to 27
Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Anxiety
Time Frame: Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Generalised Anxiety Disorder; each item will be rated from 0=not at all to 3=nearly every day. Total score range from 0 to 21.
Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Physical Health
Time Frame: Baseline (T0), 32 weeks after baseline assessment (T4)
Lawton Instrumental Activities of Daily Living; each item will be rated 0=dependent to 1=independent. Total scores range from 0 to 8.
Baseline (T0), 32 weeks after baseline assessment (T4)
Physical Health
Time Frame: Baseline (T0), 32 weeks after baseline assessment (T4)
Activities of Daily Living; each item will be rate from 0=dependent to 5/10=independent. Total scores range from 0 to 100.
Baseline (T0), 32 weeks after baseline assessment (T4)
Physical Symptoms
Time Frame: Baseline (T0), 32 weeks after baseline assessment (T4)
Wahler Physical Symptoms Inventory; each item will be rated from 0=almost never agree to 5=agree almost every day. Total score range from 0 to 210.
Baseline (T0), 32 weeks after baseline assessment (T4)
Chronic Illness
Time Frame: Baseline (T0), 32 weeks after baseline assessment (T4)
Participants will indicate any presence of chronic illness (e.g., diabetes, asthma, high blood pressure).
Baseline (T0), 32 weeks after baseline assessment (T4)
Caregiver Burden
Time Frame: Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
12-item Zarit Burden Interview Scale ; each item will be rated from 0=Never to 4=Nearly always. Total scores range from 0 to 48.
Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Psychological Well-Being
Time Frame: Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
18-item Ryff Psychological Well-Being scale, each item range from 1-strongly agree to 7-strongly disagree. Total score range from 18-126.
Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Memory and Behaviour Problems
Time Frame: Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Revised Memory and Behavior Problems Checklist; a 24-item checklist from 0=never occurred/not at all to 4=daily/extremely. Higher score indicate more frequent behavioral problems/caregiver distress
Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Neuropsychiatric
Time Frame: Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Neuropsychiatric Inventory Questionnaire; classified each of the 12 domain into presence of symptom, frequency, severity, and caregiver distress.
Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Sleep Quality
Time Frame: Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Pittsburgh Sleep Quality Index; each item will be rated from 0=No difficulty to 3=Severe difficulty. Total scores range from 0 to 21. Higher scores indicating poorer sleep quality
Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Physical and Mental Health
Time Frame: Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
12-item Short Form Health Survey, Version 2 (SF-12v2). Item responses are aggregated using standard scoring procedures to generate two summary scores: physical and mental. Higher scores indicating better health status
Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Caregiving
Time Frame: Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)
Revised Scale for Caregiving Self-efficacy; 15-item scale. Total score is 100.
Baseline (T0), 6 weeks after baseline assessment (T1), 10 weeks after baseline assessment (T2), 20 weeks after baseline assessment (T3), 32 weeks after baseline assessment (T4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Education University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Hong Kong
Columbia University
The Hong Kong Polytechnic University
Penn State University
Deakin University
Lingnan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kee Lee Chou, PhD, The Education University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-2024-0387
  • 22231921 (Other Grant/Funding Number: Research Fund Secretariat, Health Bureau)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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