Health TrialsbyHealthPanel

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

ConditionDementia Caregiver
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEducation University of Hong Kong

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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

Treatment groups

550 Participants
are divided into 13 treatment groups

13

Treatment groups

See each treatment group below.

Group A: Active controlActive comparator 1 intervention
Group B: App & Human Coaching + Continue InterventionExperimental treatment 1 intervention
Group C: App & Human Coaching + Increase intensity in human coachingExperimental treatment 1 intervention
Group D: App & Human Coaching + BoosterExperimental treatment 1 intervention
Group E: App Coaching + Continue InterventionExperimental treatment 1 intervention
Group F: App Coaching + Increase intensity in human coachingExperimental treatment 1 intervention
Group G: App Coaching + BoosterExperimental treatment 1 intervention
Group H: Human Coaching + Continue InterventionExperimental treatment 1 intervention
Group I: Human Coaching + Increase intensity in human coachingExperimental treatment 1 intervention
Group J: Human Coaching + BoosterExperimental treatment 1 intervention
Group K: No Coaching + Continue InterventionExperimental treatment 1 intervention
Group L: No Coaching + Increase intensity in human coachingExperimental treatment 1 intervention
Group M: No Coaching + BoosterExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Stress

10-item Perceived Stress Scale; each item will be rated from 0=Never to 4=Very often. Total scores range from 0 to 40.

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 outcomes

1

Depression

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

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)
2

Sleep Quality

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

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)
3

Anxiety

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.

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)
4

Physical Health

Lawton Instrumental Activities of Daily Living; each item will be rated 0=dependent to 1=independent. Total scores range from 0 to 8.

Time frame
Baseline (T0), 32 weeks after baseline assessment (T4)

Other outcomes

1

Caregiving

Revised Scale for Caregiving Self-efficacy; 15-item scale. Total score is 100.

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)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Education University of Hong Kong

Lead sponsor

The Hong Kong Polytechnic University

Collaborator

Lingnan University

Collaborator

Columbia University

Collaborator

Penn State University

Collaborator

The University of Hong Kong

Collaborator

Deakin University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: