Alzheimer Disease, Caregiver Burnout, Dementia
Conditions
Brief 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.
Detailed description
Alzheimer's Disease and related dementias (ADRD) are debilitating conditions affecting more than 5 million Americans in 2014. With aging of the population it is projected that 8.4 million people will be diagnosed with ADRD over the next 15 years and health care costs attributable to ADRD are projected to be more than 1.2 trillion by 2050. Behavioral and Psychological Symptoms of Dementia (BPSD) (anxiety, agitation, depression) are common and often involve aggressive behavior towards family caregivers (CG) in response to unmet needs, discomfort, or frustration. BPSD are disturbing and frequently lead to caregivers seeking medication to control patient symptoms. Antipsychotic use in persons with dementia (PWD) more than doubles mortality risk; however, many caregivers are willing to accept those risks. The Choosing Wisely Guidelines from the American Psychiatric Association and American Geriatrics Society both recommend against prescribing antipsychotics as a first-line treatment for BPSD. STAR-Caregivers is an efficacious first-line behavioral treatment, endorsed by the Administration on Aging, that involves caregiver training to manage BPSD. However, the program has not been implemented widely - partly due to the cost of the programs, difficulty conducting outreach, and modality of training (in person with written materials). Adequate caregiver training and commensurate reduction in caregiver burden are the mediators (mechanisms) the Investigators will engage in this Stage III trial to reduce BPSD and discontinue antipsychotic medication use by PWD. The STAR-Caregivers program is an education, training, and support intervention demonstrated efficacious in reducing BPSD. The original program involved 8 face-to-face, in-home training sessions and 4 follow-up phone calls. The condensed version involves 4 in-home sessions with 2 phone follow-ups.18 Neither of these is feasible from a payer perspective. The investigators propose to test a self-directed, remote version called STAR-virtual training and follow-up (STAR-VTF) that leverages secure email within the member portal at Kaiser Permanente Washington to improve access to training, fidelity to the STAR principles, and to lower the cost of the program. The investigators propose a Stage III trial to ascertain the feasibility and acceptability of STAR-VTF in which (a) caregiver training materials are delivered electronically and learning is self-directed, (b) caregivers have one orientation phone visit with a social worker and (c) where caregivers receive ongoing support from a social worker via telephone and secure messaging in the web-based member portal. Investigators will compare outcomes in the STAR-VTF group to an attention control group (mailed material, links to websites, and generic secure messages). The specific aims are: Aim 1: Assess the feasibility and acceptability of conducting caregiver outreach, training, and support via social workers including: (1) willingness of caregivers to interact primarily through secure messaging (contact rates); and (2) willingness of caregivers to complete self-directed training (training completion rates). Aim 2: Assess the feasibility and acceptability of the program from the payer perspective including: (1) average time spent per home-visit (including preparation and travel time); (2) average time per month spent responding to caregiver emails and coordinating care with primary care physicians; and (3 differences in face-to-face primary care, urgent care, and emergency department visit rates by PWD. Aim 3: Test the hypotheses that (H1) caregiver participants in STAR-VTF will have lower levels of caregiver burden at 8 weeks and 6 months compared to an attention control group; and (H2) PWD participants in STAR-VTF will have lower rates of antipsychotic medication use at 6 months compared to control. Secondary outcomes are: caregiver depression and caregiver self-efficacy. The investigators propose to recruit 100 CG-PWD dyads (50 per arm). This will be the first study to test a low intensity, self-directed caregiver training program with remote support from social workers. It will also be the first study to measure changes in antipsychotic medication use by PWD after caregiver training. Kaiser Permanente is an ideal setting because investigators have access to the complete electronic health record (EHR), prescription medication use, health care use, and demographic data. The investigators will be able to identify and enroll participants in real-time using an automated data troll as investigators have done previously. This study will be an important step in expanding access to training and support in a format that could be implemented within integrated delivery systems with capitated payments (i.e., Accountable Care Organizations). Growing use of EHR portals in these organizations will further increase demand for web-based care management/support. Demand will also increase as today's near-retirees, familiar with web-based applications, develop ADRD. Kaiser Permanente has pioneered such efforts and is the lead site in the Mental Health Research Network (MHRN). Findings from this study will inform a future multi-site pragmatic trial across the 13 health systems and 12 million enrollees in the MHRN.
Interventions
BEHAVIORALSTAR-C-VTF
1. One 60 minute baseline orientation phone visit with a coach to get verbal consent for participation in the study and to acquaint the caregiver with the STAR-VTF components of good dementia care; distribute printed educational material (and links to same material online); 2. Six 30-minute follow-up phone calls with the caregiver following each of the 6 learning modules to review STAR-VTF concepts, and further brainstorm strategies to modify identified activators and consequences with the objective of reducing behavioral symptoms; 3. secure message support, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months.
BEHAVIORALControl
One 60 minute baseline orientation phone visit with a coach to get verbal consent for participation in the study. Controls will receive usual care from their primary care provider and/or psychiatrist. We will give participants an information package from the Alzheimer's Association including a list of resources. To assist with retention, and to measure responses to secure messages, we will send a template secure message to control dyads once per month in which we remind participants to contact their primary care provider if they have any issues with behavioral and psychological symptoms of dementia. Dyads in the attention control may receive information and training from their primary care provider and the Alzheimer's Association. This attention control is proposed to assess the additional impact of STAR-VTF above treatment as usual. Investigators do not intend to track non-study training receipt in the control arm.
Sponsors
National Institute on Aging (NIA)
University of Washington
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
The trial will use a parallel, two-arm, randomized trial design. Participants will be randomly assigned to the experimental intervention or control. Participants in the control condition will receive mailed material from the Alzheimer's Association, web links and template secure messages. Everyone will complete assessments at baseline, 8-weeks post-enrollment, and 6 months post-enrollment.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Burden | Change from baseline caregiver burden at 6 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Primary Care Visits Had by Patient With Dementia | 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. |
| Number of Emergency Department Visits Had by Patient With Dementia | 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. |
| Antipsychotic Prescription Fills Rate for Patient With Dementia | After 8 weeks in the study | 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. |
| Antipsychotic Prescription Refill Rate for Patient With Dementia | 8 weeks after initial prescription | Refill rates after initial medication dispensing, using automated system pharmacy data |
| Dementia Severity Rating Scale (DSRS) - Memory | 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. |
| Change in Caregiver Depression | 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. |
| Change in Caregiver Self-efficacy | 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. |
| Kingston Caregiver Stress Scale | 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. |
| Number of Caregivers Who Responded to Surveys at 8-weeks | 8 weeks from baseline | We report the number of caregivers who completed their 8 week surveys by study arm. |
| Number of Caregivers Who Responded to Surveys at 6-months | 6 months from baseline | We report the number of caregivers who completed their 6-month surveys by study arm. |
| Number of Dyads Who Complete STAR-C VTF Online Training | 8 weeks from baseline | 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. |
| Dementia Severity Rating Scale (DSRS) - Speech and Language | 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. |
| Dementia Severity Rating Scale (DSRS) - Recognition of Family Members | 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. |
| Dementia Severity Rating Scale (DSRS) - Orientation to Time | 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. |
| Dementia Severity Rating Scale (DSRS) - Orientation to Place | 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. |
| Dementia Severity Rating Scale (DSRS) - Ability to Make Decisions | 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. |
| Dementia Severity Rating Scale (DSRS) - Social & Community Activity | 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. |
| Dementia Severity Rating Scale (DSRS) - Home Activities & Responsibilities | 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. |
| Dementia Severity Rating Scale (DSRS) - Personal Care - Cleanliness | 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. |
| Dementia Severity Rating Scale (DSRS) - Eating | 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. |
| Dementia Severity Rating Scale (DSRS) - Control of Urination and Bowels | 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. |
| Dementia Severity Rating Scale (DSRS) - Ability to Get From Place to Place | 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. |
| Number of Inpatient Visits Had by Patient With Dementia | End of follow-up (6 months) | Measured as the total number of inpatient visits had by patients with dementia within the study 6-month period. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Functional Activities Questionnaire (FAQ) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 32 |
| 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. | 35 |
| 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. | 35 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 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
| Characteristic | STAR-C VTF - Patient With Dementia | Total | Usual Care - Patient With Dementia | STAR-C VTF - Caregiver | Usual Care - Caregiver |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 35 Participants | 105 Participants | 32 Participants | 19 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 11 Participants | 0 Participants | 8 Participants | 3 Participants |
| Caregiver Mastery Scale | — | 20.3 units on a scale STANDARD_DEVIATION 3.3 | — | 20.2 units on a scale STANDARD_DEVIATION 3.37 | 20.5 units on a scale STANDARD_DEVIATION 3.28 |
| Dementia Severity Rating Scale Ability to Get from Place to Place | — | 2.21 units on a scale STANDARD_DEVIATION 1.14 | — | 2.20 units on a scale STANDARD_DEVIATION 1.03 | 2.22 units on a scale STANDARD_DEVIATION 1.3 |
| Dementia Severity Rating Scale Ability to Make Decisions | — | 2.33 units on a scale STANDARD_DEVIATION 0.94 | — | 2.50 units on a scale STANDARD_DEVIATION 0.94 | 2.09 units on a scale STANDARD_DEVIATION 0.92 |
| Dementia Severity Rating Scale Control of Urination and Bowels | — | 1.52 units on a scale STANDARD_DEVIATION 1.36 | — | 1.63 units on a scale STANDARD_DEVIATION 1.35 | 1.36 units on a scale STANDARD_DEVIATION 1.4 |
| Dementia Severity Rating Scale Eating | — | 0.49 units on a scale STANDARD_DEVIATION 0.67 | — | 0.43 units on a scale STANDARD_DEVIATION 0.63 | 0.57 units on a scale STANDARD_DEVIATION 0.75 |
| Dementia Severity Rating Scale Home Activities and Responsibilities | — | 2.27 units on a scale STANDARD_DEVIATION 1.1 | — | 2.37 units on a scale STANDARD_DEVIATION 1.23 | 2.14 units on a scale STANDARD_DEVIATION 1.08 |
| Dementia Severity Rating Scale Memory | — | 3.54 units on a scale STANDARD_DEVIATION 1.35 | — | 3.23 units on a scale STANDARD_DEVIATION 1.38 | 3.96 units on a scale STANDARD_DEVIATION 1.21 |
| Dementia Severity Rating Scale Orientation to Place | — | 1.46 units on a scale STANDARD_DEVIATION 1.07 | — | 1.40 units on a scale STANDARD_DEVIATION 1.1 | 1.55 units on a scale STANDARD_DEVIATION 1.06 |
| Dementia Severity Rating Scale Orientation to Time | — | 1.33 units on a scale STANDARD_DEVIATION 0.81 | — | 1.30 units on a scale STANDARD_DEVIATION 0.84 | 1.36 units on a scale STANDARD_DEVIATION 0.79 |
| Dementia Severity Rating Scale Personal Care - Cleanliness | — | 1.17 units on a scale STANDARD_DEVIATION 0.79 | — | 1.20 units on a scale STANDARD_DEVIATION 0.81 | 1.14 units on a scale STANDARD_DEVIATION 0.77 |
| Dementia Severity Rating Scale Recognition of Family Members | — | 1.13 units on a scale STANDARD_DEVIATION 1.12 | — | 0.93 units on a scale STANDARD_DEVIATION 0.98 | 1.40 units on a scale STANDARD_DEVIATION 1.26 |
| Dementia Severity Rating Scale Social & Community Activity | — | 2.44 units on a scale STANDARD_DEVIATION 0.85 | — | 2.33 units on a scale STANDARD_DEVIATION 0.92 | 2.59 units on a scale STANDARD_DEVIATION 0.73 |
| Dementia Severity Rating Scale Speech & Language | — | 2.38 units on a scale STANDARD_DEVIATION 1.46 | — | 2.27 units on a scale STANDARD_DEVIATION 1.46 | 2.55 units on a scale STANDARD_DEVIATION 1.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 111 Participants | 31 Participants | 27 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants |
| Functional Activities Questionnaire | — | 22.2 units on a scale STANDARD_DEVIATION 6.42 | — | 22.3 units on a scale STANDARD_DEVIATION 5.23 | 22.0 units on a scale STANDARD_DEVIATION 7.83 |
| Kingston Caregiver Stress | — | 22.9 units on a scale STANDARD_DEVIATION 6.66 | — | 22.3 units on a scale STANDARD_DEVIATION 6.57 | 23.6 units on a scale STANDARD_DEVIATION 6.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 110 Participants | 29 Participants | 26 Participants | 22 Participants |
| Region of Enrollment United States | 35 participants | 67 participants | 32 participants | 35 participants | 32 participants |
| Revised Memory and Problem Behavioral Checklist | — | 28.3 units on a scale STANDARD_DEVIATION 16.54 | — | 30.5 units on a scale STANDARD_DEVIATION 16.69 | 25.7 units on a scale STANDARD_DEVIATION 16.38 |
| RMBPC, Depression subscale | — | 10.1 units on a scale STANDARD_DEVIATION 10.37 | — | 12.1 units on a scale STANDARD_DEVIATION 11.94 | 7.3 units on a scale STANDARD_DEVIATION 7.22 |
| Sex: Female, Male Female | 17 Participants | 66 Participants | 14 Participants | 17 Participants | 18 Participants |
| Sex: Female, Male Male | 18 Participants | 50 Participants | 18 Participants | 10 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 2 / 32 | 0 / 35 | 2 / 35 |
| other Total, other adverse events | 0 / 32 | 0 / 32 | 0 / 35 | 4 / 35 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 | 0 / 35 | 0 / 35 |
Outcome results
Primary
Change in Caregiver Burden
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Change in Caregiver Burden | 24.44 units on a scale |
| STAR-C VTF | Change in Caregiver Burden | 22.30 units on a scale |
p-value: 0.97Regression, Linear
Secondary
Antipsychotic Prescription Fills Rate for Patient With Dementia
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Antipsychotic Prescription Fills Rate for Patient With Dementia | 0.154 Average number of prescription fills |
| STAR-C VTF | Antipsychotic Prescription Fills Rate for Patient With Dementia | 0.031 Average number of prescription fills |
p-value: 0.08Regression, Linear
Secondary
Antipsychotic Prescription Refill Rate for Patient With Dementia
Refill rates after initial medication dispensing, using automated system pharmacy data
Time frame: 8 weeks after initial prescription
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 refills.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Antipsychotic Prescription Refill Rate for Patient With Dementia | .094 Average number of prescription refills |
| STAR-C VTF | Antipsychotic Prescription Refill Rate for Patient With Dementia | 0.114 Average number of prescription refills |
p-value: 0.79Regression, Linear
Secondary
Change in Caregiver Depression
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.
Time frame: 6 months from baseline
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Change in Caregiver Depression | 7.80 units on a scale |
| STAR-C VTF | Change in Caregiver Depression | 6.32 units on a scale |
p-value: 0.55Regression, Linear
Secondary
Change in Caregiver Self-efficacy
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.
Time frame: Change from baseline caregiver mastery 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Change in Caregiver Self-efficacy | 20.44 units on a scale |
| STAR-C VTF | Change in Caregiver Self-efficacy | 21.42 units on a scale |
p-value: 0.26Regression, Linear
Secondary
Dementia Severity Rating Scale (DSRS) - Ability to Get From Place to Place
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.
Time frame: 6 months from baseline
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Dementia Severity Rating Scale (DSRS) - Ability to Get From Place to Place | 2.43 units on a scale |
| STAR-C VTF | Dementia Severity Rating Scale (DSRS) - Ability to Get From Place to Place | 2.50 units on a scale |
p-value: 0.8Regression, Linear
Secondary
Dementia Severity Rating Scale (DSRS) - Ability to Make Decisions
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.
Time frame: 6 months from baseline
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Dementia Severity Rating Scale (DSRS) - Ability to Make Decisions | 2.64 units on a scale |
| STAR-C VTF | Dementia Severity Rating Scale (DSRS) - Ability to Make Decisions | 2.47 units on a scale |
p-value: 0.28Regression, Linear
Secondary
Dementia Severity Rating Scale (DSRS) - Control of Urination and Bowels
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.
Time frame: 6 months from baseline
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Dementia Severity Rating Scale (DSRS) - Control of Urination and Bowels | 1.94 units on a scale |
| STAR-C VTF | Dementia Severity Rating Scale (DSRS) - Control of Urination and Bowels | 1.97 units on a scale |
p-value: 0.85Regression, Linear
Secondary
Dementia Severity Rating Scale (DSRS) - Eating
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.
Time frame: 6 months from baseline
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Dementia Severity Rating Scale (DSRS) - Eating | 0.56 units on a scale |
| STAR-C VTF | Dementia Severity Rating Scale (DSRS) - Eating | 0.83 units on a scale |
p-value: 0.22Regression, Linear
Secondary
Dementia Severity Rating Scale (DSRS) - Home Activities & Responsibilities
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.
Time frame: 6 months from baseline
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Dementia Severity Rating Scale (DSRS) - Home Activities & Responsibilities | 2.91 units on a scale |
| STAR-C VTF | Dementia Severity Rating Scale (DSRS) - Home Activities & Responsibilities | 2.45 units on a scale |
p-value: 0.04Regression, Linear
Secondary
Dementia Severity Rating Scale (DSRS) - Memory
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.
Time frame: 6 months from baseline
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Dementia Severity Rating Scale (DSRS) - Memory | 4.05 units on a scale |
| STAR-C VTF | Dementia Severity Rating Scale (DSRS) - Memory | 3.88 units on a scale |
p-value: 0.6Regression, Linear
Secondary
Dementia Severity Rating Scale (DSRS) - Orientation to Place
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.
Time frame: 6 months from baseline
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Dementia Severity Rating Scale (DSRS) - Orientation to Place | 1.92 units on a scale |
| STAR-C VTF | Dementia Severity Rating Scale (DSRS) - Orientation to Place | 1.96 units on a scale |
p-value: 0.63Regression, Linear
Secondary
Dementia Severity Rating Scale (DSRS) - Orientation to Time
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.
Time frame: 6 months from baseline
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Dementia Severity Rating Scale (DSRS) - Orientation to Time | 1.69 units on a scale |
| STAR-C VTF | Dementia Severity Rating Scale (DSRS) - Orientation to Time | 1.62 units on a scale |
p-value: 0.55Regression, Linear
Secondary
Dementia Severity Rating Scale (DSRS) - Personal Care - Cleanliness
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.
Time frame: 6 months from baseline
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Dementia Severity Rating Scale (DSRS) - Personal Care - Cleanliness | 1.36 units on a scale |
| STAR-C VTF | Dementia Severity Rating Scale (DSRS) - Personal Care - Cleanliness | 1.37 units on a scale |
p-value: 0.98Regression, Linear
Secondary
Dementia Severity Rating Scale (DSRS) - Recognition of Family Members
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.
Time frame: 6 months from baseline
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Dementia Severity Rating Scale (DSRS) - Recognition of Family Members | 1.10 units on a scale |
| STAR-C VTF | Dementia Severity Rating Scale (DSRS) - Recognition of Family Members | 1.33 units on a scale |
p-value: 0.46Regression, Linear
Secondary
Dementia Severity Rating Scale (DSRS) - Social & Community Activity
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.
Time frame: 6 months from baseline
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Dementia Severity Rating Scale (DSRS) - Social & Community Activity | 2.62 units on a scale |
| STAR-C VTF | Dementia Severity Rating Scale (DSRS) - Social & Community Activity | 2.68 units on a scale |
p-value: 0.82Regression, Linear
Secondary
Dementia Severity Rating Scale (DSRS) - Speech and Language
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.
Time frame: 6 months from baseline
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Dementia Severity Rating Scale (DSRS) - Speech and Language | 2.68 units on a scale |
| STAR-C VTF | Dementia Severity Rating Scale (DSRS) - Speech and Language | 2.68 units on a scale |
p-value: 0.86Regression, Linear
Secondary
Kingston Caregiver Stress Scale
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.
Time frame: 6 months from baseline
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Kingston Caregiver Stress Scale | 22.13 units on a scale |
| STAR-C VTF | Kingston Caregiver Stress Scale | 20.46 units on a scale |
p-value: 0.42Regression, Linear
Secondary
Number of Caregivers Who Responded to Surveys at 6-months
We report the number of caregivers who completed their 6-month surveys by study arm.
Time frame: 6 months from baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Caregivers Who Responded to Surveys at 6-months | 18 Participants |
| STAR-C VTF | Number of Caregivers Who Responded to Surveys at 6-months | 22 Participants |
Secondary
Number of Caregivers Who Responded to Surveys at 8-weeks
We report the number of caregivers who completed their 8 week surveys by study arm.
Time frame: 8 weeks from baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Caregivers Who Responded to Surveys at 8-weeks | 20 Participants |
| STAR-C VTF | Number of Caregivers Who Responded to Surveys at 8-weeks | 28 Participants |
Secondary
Number of Dyads Who Complete STAR-C VTF 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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Number of Dyads Who Complete STAR-C VTF Online Training | 0 dyads |
| STAR-C VTF | Number of Dyads Who Complete STAR-C VTF Online Training | 30 dyads |
Secondary
Number of Emergency Department Visits Had by Patient With Dementia
Measured as the total number of emergency department visits had by patients with dementia within the study 6-month period.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Number of Emergency Department Visits Had by Patient With Dementia | 13 Emergency Department Visits |
| STAR-C VTF | Number of Emergency Department Visits Had by Patient With Dementia | 17 Emergency Department Visits |
Secondary
Number of Inpatient Visits Had by Patient With Dementia
Measured as the total number of inpatient visits had by patients with dementia within the study 6-month period.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Number of Inpatient Visits Had by Patient With Dementia | 5 Inpatient Visits |
| STAR-C VTF | Number of Inpatient Visits Had by Patient With Dementia | 2 Inpatient Visits |
Secondary
Number of Primary Care Visits Had by Patient With Dementia
Measured as the total number of primary care visits had by the patients with dementia within the study 6-month period.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Number of Primary Care Visits Had by Patient With Dementia | 22 Primary Care Visits |
| STAR-C VTF | Number of Primary Care Visits Had by Patient With Dementia | 30 Primary Care Visits |
Other Pre-specified
Functional Activities Questionnaire (FAQ)
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.
Time frame: 6 months from baseline
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Functional Activities Questionnaire (FAQ) | 22.97 units on a scale |
| STAR-C VTF | Functional Activities Questionnaire (FAQ) | 24.34 units on a scale |