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NCT Number: NCT07444866

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

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

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Key information

Conditions

Dementia Caregiver

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Active Control

Behavioral

No APP based coaching, no human coaching, no rerandomization, no MRT

Behavioral: Continue

Behavioral

Continue with existing intervention plan

Behavioral: Enhance human coaching

Behavioral

Increase intensity of human coaching

Behavioral: Booster

Behavioral

Add a booster session

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Education University of Hong Kong

Other

Collaborators

  • Columbia University
  • Deakin University
  • Lingnan University
  • Penn State University
  • The Hong Kong Polytechnic University
  • The University of Hong Kong

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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