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Not yet recruiting NCT07444866

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

No phase Interventional Dementia Caregiver

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active Control, Behavioral: Continue, Behavioral: Enhance human coaching, Behavioral: Booster.
Who it may be relevant to
Registry conditions: Dementia Caregiver. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Behavioral Active Control
    No APP based coaching, no human coaching, no rerandomization, no MRT
  • Behavioral Behavioral: Continue
    Continue with existing intervention plan
  • Behavioral Behavioral: Enhance human coaching
    Increase intensity of human coaching
  • Behavioral Behavioral: Booster
    Add a booster session

Primary outcome measures

  • 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)]
Secondary outcome measures (12)
  • 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)]
  • 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)]
  • 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)]
  • Physical Health [Time frame: Baseline (T0), 32 weeks after baseline assessment (T4)]
  • Physical Health [Time frame: Baseline (T0), 32 weeks after baseline assessment (T4)]
  • Physical Symptoms [Time frame: Baseline (T0), 32 weeks after baseline assessment (T4)]
  • Chronic Illness [Time frame: 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Factorial
Masking
Double blind
Primary purpose
Prevention

Study locations

Hong Kong · 1 center
  • The Education University of Hong Kong — Hong Kong

Publications

  • Cheung DSK, Kor PPK, Chu AMY, Xie H, Qian M, Chu LW, Zarit S, Chou KL. Machine learning-enabled behavioural and psychological symptoms of dementia management intervention for dementia caregivers: protocol for a hybrid factorial SMART-MRT trial. BMC Geriatr. 2026 Jul 13. doi: 10.1186/s12877-026-07894-w. Online ahead of print. PMID 42443790

Identifiers

NCT: NCT07444866 · 2023-2024-0387 · 22231921

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗