N/A Completed N=134 Randomized Health Services Research

STAR Caregivers - Virtual Training and Follow-up

Alzheimer's Disease · Dementia · Caregiver Burnout

Source: ClinicalTrials.gov NCT04271046 ↗

Enrolled (actual)

134

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcomePrimary: Change in Caregiver Burden — 24.44; 22.30 units on a scale — p=0.97

Summary

This study evaluates the effectiveness of a caregiver outreach, training, and support program for caregivers of people with dementia who are using antipsychotic medication to manage agitation/aggression. The Investigators will conduct a randomized trial of the caregiver program compared to a control group to measure differences in caregiver burden and discontinuation of antipsychotic medication use. The results will help in expanding access to and delivery of empirically supported behavioral health services for caregivers and people with dementia.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Caregiver Burden	24.44; 22.30	0.97
SECONDARY Change in Caregiver Depression	7.80; 6.32	0.55
SECONDARY Change in Caregiver Self-efficacy	20.44; 21.42	0.26
SECONDARY Kingston Caregiver Stress Scale	22.13; 20.46	0.42
SECONDARY Number of Caregivers Who Responded to Surveys at 8-weeks	20; 28	—
SECONDARY Number of Caregivers Who Responded to Surveys at 6-months	18; 22	—
SECONDARY Number of Dyads Who Complete STAR-C VTF Online Training	0; 30	—
SECONDARY Number of Inpatient Visits Had by Patient With Dementia	5; 2	—
SECONDARY Number of Primary Care Visits Had by Patient With Dementia	22; 30	—
SECONDARY Number of Emergency Department Visits Had by Patient With Dementia	13; 17	—
SECONDARY Antipsychotic Prescription Fills Rate for Patient With Dementia	0.154; 0.031	0.08
SECONDARY Antipsychotic Prescription Refill Rate for Patient With Dementia	.094; 0.114	0.79
SECONDARY Dementia Severity Rating Scale (DSRS) - Memory	4.05; 3.88	0.60
SECONDARY Dementia Severity Rating Scale (DSRS) - Speech and Language	2.68; 2.68	0.86
SECONDARY Dementia Severity Rating Scale (DSRS) - Recognition of Family Members	1.10; 1.33	0.46
SECONDARY Dementia Severity Rating Scale (DSRS) - Orientation to Time	1.69; 1.62	0.55
SECONDARY Dementia Severity Rating Scale (DSRS) - Orientation to Place	1.92; 1.96	0.63
SECONDARY Dementia Severity Rating Scale (DSRS) - Ability to Make Decisions	2.64; 2.47	0.28
SECONDARY Dementia Severity Rating Scale (DSRS) - Social & Community Activity	2.62; 2.68	0.82
SECONDARY Dementia Severity Rating Scale (DSRS) - Home Activities & Responsibilities	2.91; 2.45	0.04 sig
SECONDARY Dementia Severity Rating Scale (DSRS) - Personal Care - Cleanliness	1.36; 1.37	0.98
SECONDARY Dementia Severity Rating Scale (DSRS) - Eating	0.56; 0.83	0.22
SECONDARY Dementia Severity Rating Scale (DSRS) - Control of Urination and Bowels	1.94; 1.97	0.85
SECONDARY Dementia Severity Rating Scale (DSRS) - Ability to Get From Place to Place	2.43; 2.50	0.80

Eligibility Criteria

Current Criteria:

Investigators will identify and recruit Person with Dementia-Caregiver dyads in which the person with dementia has has made a healthcare visit in the last week where a diagnosis of Alzheimer's Disease or related dementia was recorded. Because we will enroll dyads, there are inclusion/exclusion criteria for both.

Participants

Persons with dementia inclusion criteria:

Aged ≥ 65 years Confirmed diagnosis of Alzheimer's Disease related disorders (ADRD) from the patient Electronic Health Record (EHR) or primary care physician KP members for a minimum of 180 days prior to the index visit date. Expected to live >= 6 months from enrollment

Persons with dementia exclusion criteria:

A diagnosis of bipolar disorder or schizophreniform disorder
The primary care physician's opinion is that the person with dementia is expected to live less than 6 months.
Less that 65 years of age
Primary language is not English (patient requires a translator).

Caregiver inclusion criteria:

Aged ≥ 21 years
Lives with person with dementia or within 8 miles
Provides at least 8 hours of care per week
Have access to a computer or other device where they can access MyChart, personal email, and websites to complete online training
Use MyChart to email the doctors that care for the PWD they are caring for

Caregivers exclusion criteria:

Diagnosis of Alzheimer's Disease or related disorders.
Less than 21 years of age
Are not the spouse, or adult child
Unable to read and speak English
Do not have access to a computer or other device where they can access MyChart, personal email, and websites to complete online training
Do not use MyChart to email to doctors that care for the PWD they are caring for.

Previous Criteria:

Participants

The investigators will identify and recruit Person with Dementia-Caregiver dyads in which the person with dementia has filled a new prescription for an antipsychotic medication. Because we will enroll dyads, there are inclusion/exclusion criteria for both.

Persons with dementia inclusion criteria:

Aged ≥ 65 years
Diagnosis of Alzheimer's Disease related dementia (ADRD)
A new prescription for an antipsychotic medication
Living at home
Expected to live >= 6 months from enrollment

Persons with dementia exclusion criteria:

A diagnosis of bipolar disorder or schizophreniform disorder
Living in an assisted living, skilled nursing facility, or memory facility
The primary care physician's opinion is that the person with dementia is expected to live less than 6 months.

Caregiver inclusion criteria:

Aged ≥ 21 years
Lives with person with dementia or within 8 miles
Provides at least 8 hours of care per week

Caregivers exclusion criteria:

Diagnosis of Alzheimer's Disease or related disorders.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04271046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.