Trial Outcomes & Findings for STAR Caregivers - Virtual Training and Follow-up (NCT NCT04271046)

Last Updated: 2025-02-04

Results Overview

Self-reported caregiver burden assessed by the Disruption subscale on the Revised Memory and Behavior Problem Checklist (RMBPC) questionnaire. The range in subscale scores is 0 to 32 with higher scores representing a worse outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

67 participants

Primary outcome timeframe

Change from baseline caregiver burden at 6 months.

Results posted on

2025-02-04

Participant Flow

Participants with Dementia-Caregiver dyads were recruited based on whether the person with dementia had made a healthcare visit within the last week where a diagnosis of Alzheimer's Disease or related dementia was recorded between April 2020 and January 2023. The first dyad participants were enrolled in May 2020 and the last dyad was enrolled February 2023.

Using electronic health records, 935 patients with a dementia diagnosis were identified. After initial review of their electronic health record and contacting their provider for an opt out response, 592 fulfilled a subset of study inclusion criteria and their caregiver on file was contacted to assess further inclusion criteria. Of the 577 eligible dyad participants, 125 agreed to complete a phone screening for eligibility, with 67 dyads randomized and enrolled in the study.

Participant milestones

Participant milestones
Measure	Usual Care - Caregiver Caregivers randomized to the usual care control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	Usual Care - Patient With Dementia Patients with dementia randomized to the usual care control condition will be asked for consent to have their caregiver participate in the study and for the use of their medical record data.	STAR-C VTF - Caregiver Randomized Caregivers are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.	STAR-C VTF - Patient With Dementia Patients with dementia randomized to the STAR-C VTF condition will be asked for consent to have their caregiver participate in the study and for the use of their medical record data.
Overall Study STARTED	32	32	35	35
Overall Study Baseline Surveys	31	0	34	0
Overall Study 8-week Surveys	20	0	28	0
Overall Study 6-month Surveys	18	0	22	0
Overall Study COMPLETED	18	0	22	0
Overall Study NOT COMPLETED	14	32	13	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care - Caregiver Caregivers randomized to the usual care control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	Usual Care - Patient With Dementia Patients with dementia randomized to the usual care control condition will be asked for consent to have their caregiver participate in the study and for the use of their medical record data.	STAR-C VTF - Caregiver Randomized Caregivers are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.	STAR-C VTF - Patient With Dementia Patients with dementia randomized to the STAR-C VTF condition will be asked for consent to have their caregiver participate in the study and for the use of their medical record data.
Overall Study Death	0	2	0	2
Overall Study Lost to Follow-up	12	12	11	11
Overall Study Patient with Dementia Died	2	0	2	0
Overall Study Patient with dementia were not administered surveys	0	18	0	22

Baseline Characteristics

We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care - Caregiver n=32 Participants Caregivers randomized to the usual care control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	Usual Care - Patient With Dementia n=32 Participants Patients with dementia randomized to the usual care control condition will be asked for consent to have their caregiver participate in the study and for the use of their medical record data.	STAR-C VTF - Caregiver n=35 Participants Randomized Caregivers are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.	STAR-C VTF - Patient With Dementia n=35 Participants Patients with dementia randomized to the STAR-C VTF condition will be asked for consent to have their caregiver participate in the study and for the use of their medical record data.	Total n=134 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=22 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	0 Participants n=32 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	0 Participants n=27 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	0 Participants n=35 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	0 Participants n=116 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.
Age, Categorical Between 18 and 65 years	3 Participants n=22 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	0 Participants n=32 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	8 Participants n=27 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	0 Participants n=35 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	11 Participants n=116 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.
Age, Categorical >=65 years	19 Participants n=22 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	32 Participants n=32 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	19 Participants n=27 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	35 Participants n=35 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	105 Participants n=116 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.
Sex: Female, Male Female	18 Participants n=22 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	14 Participants n=32 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	17 Participants n=27 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	17 Participants n=35 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	66 Participants n=116 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.
Sex: Female, Male Male	4 Participants n=22 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	18 Participants n=32 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	10 Participants n=27 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	18 Participants n=35 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.	50 Participants n=116 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C VTF. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study. There is not a row to display missing data in this table.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=22 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=32 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=27 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	2 Participants n=35 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	2 Participants n=116 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=22 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	31 Participants n=32 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	27 Participants n=27 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	31 Participants n=35 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	111 Participants n=116 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=22 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	1 Participants n=32 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=27 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	2 Participants n=35 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	3 Participants n=116 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=22 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=32 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=27 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=35 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=116 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.
Race (NIH/OMB) Asian	0 Participants n=22 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=32 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=27 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=35 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=116 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=22 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=32 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=27 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=35 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=116 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.
Race (NIH/OMB) Black or African American	0 Participants n=22 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	1 Participants n=32 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	1 Participants n=27 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=35 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	2 Participants n=116 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.
Race (NIH/OMB) White	22 Participants n=22 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	29 Participants n=32 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	26 Participants n=27 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	33 Participants n=35 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	110 Participants n=116 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.
Race (NIH/OMB) More than one race	0 Participants n=22 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=32 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=27 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=35 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=116 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=22 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	2 Participants n=32 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	0 Participants n=27 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	2 Participants n=35 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.	4 Participants n=116 Participants • We collected the caregiver's demographic data at a later date for both arms; we have missing data for 10 caregivers in usual care and 8 caregivers in STAR-C. The later collection date made it harder to reach participants that already completed the intervention, had withdrawn, or had completed the study.
Region of Enrollment United States	32 participants n=32 Participants	32 participants n=32 Participants	35 participants n=35 Participants	35 participants n=35 Participants	67 participants n=134 Participants
Caregiver Mastery Scale	20.5 units on a scale STANDARD_DEVIATION 3.28 • n=32 Participants • The Caregiver Mastery Scale is only completed by the caregiver.	—	20.2 units on a scale STANDARD_DEVIATION 3.37 • n=35 Participants • The Caregiver Mastery Scale is only completed by the caregiver.	—	20.3 units on a scale STANDARD_DEVIATION 3.30 • n=67 Participants • The Caregiver Mastery Scale is only completed by the caregiver.
Revised Memory and Problem Behavioral Checklist	25.7 units on a scale STANDARD_DEVIATION 16.38 • n=32 Participants • The Revised Memory and Problem Behavioral Checklist is only completed by the caregiver.	—	30.5 units on a scale STANDARD_DEVIATION 16.69 • n=35 Participants • The Revised Memory and Problem Behavioral Checklist is only completed by the caregiver.	—	28.3 units on a scale STANDARD_DEVIATION 16.54 • n=67 Participants • The Revised Memory and Problem Behavioral Checklist is only completed by the caregiver.
Kingston Caregiver Stress	23.6 units on a scale STANDARD_DEVIATION 6.90 • n=32 Participants • The Kingston Caregiver Stress is only completed by the caregiver.	—	22.3 units on a scale STANDARD_DEVIATION 6.57 • n=35 Participants • The Kingston Caregiver Stress is only completed by the caregiver.	—	22.9 units on a scale STANDARD_DEVIATION 6.66 • n=67 Participants • The Kingston Caregiver Stress is only completed by the caregiver.
RMBPC, Depression subscale	7.3 units on a scale STANDARD_DEVIATION 7.22 • n=32 Participants • The RMBPC, Depression subscale is only completed by the caregiver.	—	12.1 units on a scale STANDARD_DEVIATION 11.94 • n=35 Participants • The RMBPC, Depression subscale is only completed by the caregiver.	—	10.1 units on a scale STANDARD_DEVIATION 10.37 • n=67 Participants • The RMBPC, Depression subscale is only completed by the caregiver.
Functional Activities Questionnaire	22.0 units on a scale STANDARD_DEVIATION 7.83 • n=32 Participants • The Functional Activities Questionnaire is only completed by the caregiver.	—	22.3 units on a scale STANDARD_DEVIATION 5.23 • n=35 Participants • The Functional Activities Questionnaire is only completed by the caregiver.	—	22.2 units on a scale STANDARD_DEVIATION 6.42 • n=67 Participants • The Functional Activities Questionnaire is only completed by the caregiver.
Dementia Severity Rating Scale Memory	3.96 units on a scale STANDARD_DEVIATION 1.21 • n=32 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	3.23 units on a scale STANDARD_DEVIATION 1.38 • n=35 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	3.54 units on a scale STANDARD_DEVIATION 1.35 • n=67 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.
Dementia Severity Rating Scale Speech & Language	2.55 units on a scale STANDARD_DEVIATION 1.47 • n=32 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	2.27 units on a scale STANDARD_DEVIATION 1.46 • n=35 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	2.38 units on a scale STANDARD_DEVIATION 1.46 • n=67 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.
Dementia Severity Rating Scale Recognition of Family Members	1.40 units on a scale STANDARD_DEVIATION 1.26 • n=32 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	0.93 units on a scale STANDARD_DEVIATION 0.98 • n=35 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	1.13 units on a scale STANDARD_DEVIATION 1.12 • n=67 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.
Dementia Severity Rating Scale Orientation to Time	1.36 units on a scale STANDARD_DEVIATION 0.79 • n=32 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	1.30 units on a scale STANDARD_DEVIATION 0.84 • n=35 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	1.33 units on a scale STANDARD_DEVIATION 0.81 • n=67 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.
Dementia Severity Rating Scale Orientation to Place	1.55 units on a scale STANDARD_DEVIATION 1.06 • n=32 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	1.40 units on a scale STANDARD_DEVIATION 1.10 • n=35 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	1.46 units on a scale STANDARD_DEVIATION 1.07 • n=67 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.
Dementia Severity Rating Scale Ability to Make Decisions	2.09 units on a scale STANDARD_DEVIATION 0.92 • n=32 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	2.50 units on a scale STANDARD_DEVIATION 0.94 • n=35 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	2.33 units on a scale STANDARD_DEVIATION 0.94 • n=67 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.
Dementia Severity Rating Scale Social & Community Activity	2.59 units on a scale STANDARD_DEVIATION 0.73 • n=32 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	2.33 units on a scale STANDARD_DEVIATION 0.92 • n=35 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	2.44 units on a scale STANDARD_DEVIATION 0.85 • n=67 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.
Dementia Severity Rating Scale Home Activities and Responsibilities	2.14 units on a scale STANDARD_DEVIATION 1.08 • n=32 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	2.37 units on a scale STANDARD_DEVIATION 1.23 • n=35 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	2.27 units on a scale STANDARD_DEVIATION 1.10 • n=67 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.
Dementia Severity Rating Scale Personal Care - Cleanliness	1.14 units on a scale STANDARD_DEVIATION 0.77 • n=32 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	1.20 units on a scale STANDARD_DEVIATION 0.81 • n=35 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	1.17 units on a scale STANDARD_DEVIATION 0.79 • n=67 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.
Dementia Severity Rating Scale Eating	0.57 units on a scale STANDARD_DEVIATION 0.75 • n=32 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	0.43 units on a scale STANDARD_DEVIATION 0.63 • n=35 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	0.49 units on a scale STANDARD_DEVIATION 0.67 • n=67 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.
Dementia Severity Rating Scale Control of Urination and Bowels	1.36 units on a scale STANDARD_DEVIATION 1.40 • n=32 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	1.63 units on a scale STANDARD_DEVIATION 1.35 • n=35 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	1.52 units on a scale STANDARD_DEVIATION 1.36 • n=67 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.
Dementia Severity Rating Scale Ability to Get from Place to Place	2.22 units on a scale STANDARD_DEVIATION 1.30 • n=32 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	2.20 units on a scale STANDARD_DEVIATION 1.03 • n=35 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.	—	2.21 units on a scale STANDARD_DEVIATION 1.14 • n=67 Participants • The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale.

PRIMARY outcome

Timeframe: Change from baseline caregiver burden at 6 months.

Population: We used multiple imputation on our entire sample of 67 caregivers, including baseline survey response, 8 week survey response, and 6 month survey response. As such, all individuals contributed information to the analyses.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Change in Caregiver Burden	24.44 units on a scale Interval 19.69 to 29.2	22.30 units on a scale Interval 17.66 to 26.93

SECONDARY outcome

Timeframe: 6 months from baseline

Self-reported caregiver depression assessed by the RMBPC, Depression subscale on the Revised Memory and Behavior Problem Checklist (RMBPC) questionnaire. The range in subscale scores is 0 to 36 with higher scores representing a worse outcome.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Change in Caregiver Depression	7.80 units on a scale Interval 4.89 to 10.72	6.32 units on a scale Interval 3.88 to 8.76

SECONDARY outcome

Timeframe: Change from baseline caregiver mastery at 6 months.

Self-reported caregiver self-efficacy assessed by the Caregiver Mastery Scale. Total scores can range from 7 to 35, with higher scores reflecting greater caregiver mastery. The Caregiver Mastery Scale is a 7-item measure of self-efficacy. is a 7-item self-report scale, indicating the extent to which respondents agree (5) or disagree (1) with each item. Three items with negative statements are reverse-scored. Total scores can range from 7 to 35, with higher scores reflecting greater caregiver mastery.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Change in Caregiver Self-efficacy	20.44 units on a scale Interval 19.22 to 21.64	21.42 units on a scale Interval 20.18 to 22.65

SECONDARY outcome

Timeframe: 6 months from baseline

The Kingston Caregiver Stress Scale (KCSS) is designed to allow a family member (or other) caregiver to express his/her level of perceived stress, as it relates to caregiving. It can also be used to monitor changes in stress levels over time, as the caregiver's situation changes. Scores range from 10-50; a higher scores indicates higher levels of stress.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Kingston Caregiver Stress Scale	22.13 units on a scale Interval 19.75 to 24.52	20.46 units on a scale Interval 18.19 to 22.72

SECONDARY outcome

Timeframe: 8 weeks from baseline

We report the number of caregivers who completed their 8 week surveys by study arm.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Number of Caregivers Who Responded to Surveys at 8-weeks	20 Participants	28 Participants

SECONDARY outcome

Timeframe: 6 months from baseline

We report the number of caregivers who completed their 6-month surveys by study arm.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Number of Caregivers Who Responded to Surveys at 6-months	18 Participants	22 Participants

SECONDARY outcome

Timeframe: 8 weeks from baseline

Population: We reviewed how many caregiver - patient with dementia dyads completed the 8 weeks of online STAR-C VTF separate from those that completed the week 8 follow-up surveys. We report on the number of dyads that completed the online training from the total number enrolled. The number differs from the participant flow form because some dyads did not complete the week 8 follow-up survey but did complete the online training.

We will report completion rates by study arm at the end of the trial. Completion will be defined as completing 2 home-based visits, 1 phone-based visit and sending at least one secure message to a social worker in the baseline to 8-week period and one message in weeks 9 through 24.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Number of Dyads Who Complete STAR-C VTF Online Training	0 dyads	30 dyads

SECONDARY outcome

Timeframe: End of follow-up (6 months)

Population: We analyzed our entire sample of 67 patients with dementia to understand how many touches they had with our care delivery system throughout the entire study. The total number differs from the participant flow as that is a reflection of completed follow-up surveys and not care delivery system touches.

Measured as the total number of inpatient visits had by patients with dementia within the study 6-month period.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Number of Inpatient Visits Had by Patient With Dementia	5 Inpatient Visits	2 Inpatient Visits

SECONDARY outcome

Timeframe: End of follow-up (6 months)

Measured as the total number of primary care visits had by the patients with dementia within the study 6-month period.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Number of Primary Care Visits Had by Patient With Dementia	22 Primary Care Visits	30 Primary Care Visits

SECONDARY outcome

Timeframe: End of follow-up (6 months)

Measured as the total number of emergency department visits had by patients with dementia within the study 6-month period.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Number of Emergency Department Visits Had by Patient With Dementia	13 Emergency Department Visits	17 Emergency Department Visits

SECONDARY outcome

Timeframe: After 8 weeks in the study

Population: We analyzed our entire sample of 67 patients with dementia to understand how many prescriptions were filled for the patient with dementia after 8 weeks in the study. The total number differs from the participant flow as that is a reflection of completed follow-up surveys and not prescription fills.

Average number of prescription fills for the patient with dementia after 8 weeks enrolled in the study. This data comes from the automated system pharmacy data.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Antipsychotic Prescription Fills Rate for Patient With Dementia	0.154 Average number of prescription fills Interval 0.03 to 0.228	0.031 Average number of prescription fills Interval 0.0 to 0.93

SECONDARY outcome

Timeframe: 8 weeks after initial prescription

Refill rates after initial medication dispensing, using automated system pharmacy data

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Antipsychotic Prescription Refill Rate for Patient With Dementia	.094 Average number of prescription refills Interval 0.0 to 0.2	0.114 Average number of prescription refills Interval 0.004 to 0.224

SECONDARY outcome

Timeframe: 6 months from baseline

The Dementia Severity Rating Scale measures the severity of dementia as observed by a caregiver in the patient with dementia. The Memory subscale ranges from 0-6 and measures issues with memory. A higher subscale score indicates worse memory symptoms.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Dementia Severity Rating Scale (DSRS) - Memory	4.05 units on a scale Interval 3.69 to 4.41	3.88 units on a scale Interval 3.51 to 4.26

SECONDARY outcome

Timeframe: 6 months from baseline

The Dementia Severity Rating Scale measures the severity of dementia as observed by a caregiver in the patient with dementia. The Speech and Language subscale ranges from 0-6 and measures issues with speech and language. A higher subscale score indicates worse ability to speak and converse with others.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Dementia Severity Rating Scale (DSRS) - Speech and Language	2.68 units on a scale Interval 2.13 to 3.25	2.68 units on a scale Interval 2.1 to 3.26

SECONDARY outcome

Timeframe: 6 months from baseline

The Dementia Severity Rating Scale measures the severity of dementia as observed by a caregiver in the patient with dementia. The Recognition of Family Members subscale ranges from 0-5 and measures issues with recognition of family members. A higher subscale score indicates worse recognition of family members.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Dementia Severity Rating Scale (DSRS) - Recognition of Family Members	1.10 units on a scale Interval 0.77 to 1.43	1.33 units on a scale Interval 0.99 to 1.67

SECONDARY outcome

Timeframe: 6 months from baseline

The Dementia Severity Rating Scale measures the severity of dementia as observed by a caregiver in the patient with dementia. The Orientation to Time subscale ranges from 0-4 and measures issues with the patient with dementia's ability to orient themselves in time. A higher subscale score indicates worse ability to orient themselves in time.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Dementia Severity Rating Scale (DSRS) - Orientation to Time	1.69 units on a scale Interval 1.33 to 2.05	1.62 units on a scale Interval 1.31 to 1.93

SECONDARY outcome

Timeframe: 6 months from baseline

The Dementia Severity Rating Scale measures the severity of dementia as observed by a caregiver in the patient with dementia. The Orientation to Place subscale ranges from 0-4 and measures issues with the patient with dementia's ability to orient themselves. A higher subscale score indicates worse disorientation.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Dementia Severity Rating Scale (DSRS) - Orientation to Place	1.92 units on a scale Interval 1.53 to 2.3	1.96 units on a scale Interval 1.61 to 2.31

SECONDARY outcome

Timeframe: 6 months from baseline

The Dementia Severity Rating Scale measures the severity of dementia as observed by a caregiver in the patient with dementia. The Ability to Make Decisions subscale ranges from 0-4 and measures issues with the patient with dementia's ability to make decisions for themselves. A higher subscale score indicates worse ability to make decisions for themselves.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Dementia Severity Rating Scale (DSRS) - Ability to Make Decisions	2.64 units on a scale Interval 2.32 to 2.97	2.47 units on a scale Interval 2.11 to 2.81

SECONDARY outcome

Timeframe: 6 months from baseline

The Dementia Severity Rating Scale measures the severity of dementia as observed by a caregiver in the patient with dementia. The Social \& Community Activity subscale ranges from 0-5 and measures issues with the patient with dementia's ability to interact with those around them. A higher subscale score indicates worse ability to interact with others.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Dementia Severity Rating Scale (DSRS) - Social & Community Activity	2.62 units on a scale Interval 2.16 to 3.08	2.68 units on a scale Interval 2.4 to 2.97

SECONDARY outcome

Timeframe: 6 months from baseline

The Dementia Severity Rating Scale measures the severity of dementia as observed by a caregiver in the patient with dementia. The Home Activities \& Responsibilities subscale ranges from 0-4 and measures issues with the patient with dementia's ability to do their usual things around the house. A higher subscale score indicates worse ability to complete home activities and responsibilities.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Dementia Severity Rating Scale (DSRS) - Home Activities & Responsibilities	2.91 units on a scale Interval 2.56 to 3.28	2.45 units on a scale Interval 2.17 to 2.72

SECONDARY outcome

Timeframe: 6 months from baseline

The Dementia Severity Rating Scale measures the severity of dementia as observed by a caregiver in the patient with dementia. The Personal Care - Cleanliness subscale ranges from 0-3 and measures issues with the patient with dementia's ability to take care of their personal hygiene independently. A higher subscale score indicates worse ability to maintain their cleanliness independently.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Dementia Severity Rating Scale (DSRS) - Personal Care - Cleanliness	1.36 units on a scale Interval 0.98 to 1.75	1.37 units on a scale Interval 1.09 to 1.64

SECONDARY outcome

Timeframe: 6 months from baseline

The Dementia Severity Rating Scale measures the severity of dementia as observed by a caregiver in the patient with dementia. The Eating subscale ranges from 0-3 and measures issues with the patient with dementia's ability to eat independently. A higher subscale score indicates worse ability to eat independently.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Dementia Severity Rating Scale (DSRS) - Eating	0.56 units on a scale Interval 0.28 to 0.84	0.83 units on a scale Interval 0.51 to 1.16

SECONDARY outcome

Timeframe: 6 months from baseline

The Dementia Severity Rating Scale measures the severity of dementia as observed by a caregiver in the patient with dementia. The Control of Urination and Bowels subscale ranges from 0-4 and measures issues with the patient with dementia's ability to control their urination and bowels. A higher subscale score indicates worse ability to control their urination and bowels.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Dementia Severity Rating Scale (DSRS) - Control of Urination and Bowels	1.94 units on a scale Interval 1.51 to 2.37	1.97 units on a scale Interval 1.58 to 2.37

SECONDARY outcome

Timeframe: 6 months from baseline

The Dementia Severity Rating Scale measures the severity of dementia as observed by a caregiver in the patient with dementia. The Ability to Get From Place to Place subscale ranges from 0-6 and measures issues with the patient with dementia's ability to get around on their own. A higher subscale score indicates worse ability to get around independently.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Dementia Severity Rating Scale (DSRS) - Ability to Get From Place to Place	2.43 units on a scale Interval 2.03 to 2.83	2.50 units on a scale Interval 2.16 to 2.84

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months from baseline

The FAQ measures instrumental activities of daily living, such as preparing balanced meals and managing personal finances as observed by the caregiver in the patient with dementia. The tool consists of 10 questions with total scores ranging from 0-30. A minimum score of 9 indicates impaired functioning, and as the score increases from 9 indicating a greater reduction in functioning.

Outcome measures

Outcome measures
Measure	Usual Care n=32 Participants Participants randomized to the control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	STAR-C VTF n=35 Participants Randomized Person Living With Dementia - Caregiver dyads are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.
Functional Activities Questionnaire (FAQ)	22.97 units on a scale Interval 20.76 to 25.17	24.34 units on a scale Interval 22.21 to 26.48

Adverse Events

Usual Care - Caregiver

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care - Patient With Dementia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

STAR-C VTF - Caregiver

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

STAR-C VTF - Patient With Dementia

Serious events: 0 serious events

Other events: 4 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Usual Care - Caregiver n=32 participants at risk Caregivers randomized to the usual care control condition will have one orientation phone visit with a coach and receive mailed material from the Alzheimer's Association, web links and template secure messages.	Usual Care - Patient With Dementia n=32 participants at risk Patients with dementia randomized to the usual care control condition will be asked for consent to have their caregiver participate in the study and for the use of their medical record data.	STAR-C VTF - Caregiver n=35 participants at risk Randomized Caregivers are offered: * A telephone orientation visit with a study coach to acquaint the caregiver to the 6-session STAR-VTF program and online learning environment. * A paper-based and electronic manual to identify priority behaviors, develop plans for addressing behaviors, and make plans for pleasant events. * 6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 6 training modules. * Secure message (email) support within the patient portal, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the caregiver.	STAR-C VTF - Patient With Dementia n=35 participants at risk Patients with dementia randomized to the STAR-C VTF condition will be asked for consent to have their caregiver participate in the study and for the use of their medical record data.
General disorders Hospitalization	0.00% 0/32 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.	0.00% 0/32 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.	0.00% 0/35 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.	2.9% 1/35 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.
Injury, poisoning and procedural complications Mechanical Fall	0.00% 0/32 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.	0.00% 0/32 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.	0.00% 0/35 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.	2.9% 1/35 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.
Injury, poisoning and procedural complications Difficulty Waking	0.00% 0/32 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.	0.00% 0/32 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.	0.00% 0/35 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.	2.9% 1/35 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.
Psychiatric disorders Distress	0.00% 0/32 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.	0.00% 0/32 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.	0.00% 0/35 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.	2.9% 1/35 • Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.

Additional Information

Robert Penfold

Kaiser Permanente Washington Health Research Institute

Phone: 206-287-2232

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place