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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG061926-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| University of Washington | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group- STAR-C-VTF | Experimental | This study will use a parallel, two-arm randomized trial design. Participants will be 100 Person-with-Dementia-Caregiver dyads in which the person with dementia lives at home and recently filled a new prescription for antipsychotic medication. The experimental intervention will combine three elements:
Participants will complete self-report assessments at baseline, 8-weeks post-enrollment, and 6 months post-enrollment. Automated medication and primary care utilization data will be collected throughout the 6 month study period. |
|
| Control | Active Comparator | One orientation phone visit with a coach. Participants in the control condition will receive mailed material from the Alzheimer's Association, web links and template secure messages. Participants will complete self-report assessments at baseline, 8-weeks post-enrollment, and 6 months post-enrollment. Automated medication and primary care utilization data will be collected throughout the 6 month study period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STAR-C-VTF | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline caregiver burden at 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months from baseline |
| Change in Caregiver Self-efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Current Criteria:
Investigators will identify and recruit Person with Dementia-Caregiver dyads in which the person with dementia has has made a healthcare visit in the last week where a diagnosis of Alzheimer's Disease or related dementia was recorded. Because we will enroll dyads, there are inclusion/exclusion criteria for both.
Participants
Persons with dementia inclusion criteria:
Aged ≥ 65 years Confirmed diagnosis of Alzheimer's Disease related disorders (ADRD) from the patient Electronic Health Record (EHR) or primary care physician KP members for a minimum of 180 days prior to the index visit date. Expected to live >= 6 months from enrollment
Persons with dementia exclusion criteria:
Caregiver inclusion criteria:
Caregivers exclusion criteria:
Previous Criteria:
Participants
The investigators will identify and recruit Person with Dementia-Caregiver dyads in which the person with dementia has filled a new prescription for an antipsychotic medication. Because we will enroll dyads, there are inclusion/exclusion criteria for both.
Persons with dementia inclusion criteria:
Persons with dementia exclusion criteria:
Caregiver inclusion criteria:
Caregivers exclusion criteria:
* Diagnosis of Alzheimer's Disease or related disorders.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Washington Health Research Institute | Seattle | Washington | 98101 | United States |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | STAR-C VTF - Caregiver | Randomized Caregivers are offered:
|
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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For this study, data collected from the the patients with dementia come from their electronic health record data. Caregivers were the focus of this study and the same measures were used for both arms. Measure descriptions clearly state which are from patients with dementia and caregivers, respectively.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Usual Care - Patient With Dementia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Demographic data was collected from the patient with dementia's medical record and the caregiver demographic data was collected at a later date; we were not able to record all caregiver demographic data. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline caregiver burden at 6 months. |
|
Each participant was assessed over the course of 6 months while they were in the study, from baseline to end of study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Penfold | Kaiser Permanente Washington Health Research Institute | 206-287-2232 | robert.b.penfold@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 9, 2024 | Sep 12, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 9, 2024 | Sep 12, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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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.
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|
| Control | Behavioral | 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. |
|
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. |
| Change from baseline caregiver mastery at 6 months. |
| 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. | 6 months from baseline |
| 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. | 8 weeks from baseline |
| 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. | 6 months from baseline |
| 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. | 8 weeks from baseline |
| 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. | End of follow-up (6 months) |
| 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. | End of follow-up (6 months) |
| 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. | End of follow-up (6 months) |
| 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. | After 8 weeks in the study |
| Antipsychotic Prescription Refill Rate for Patient With Dementia | Refill rates after initial medication dispensing, using automated system pharmacy data | 8 weeks after initial prescription |
| 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. | 6 months from baseline |
| 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. | 6 months from baseline |
| 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. | 6 months from baseline |
| 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. | 6 months from baseline |
| 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. | 6 months from baseline |
| 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. | 6 months from baseline |
| 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. | 6 months from baseline |
| 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. | 6 months from baseline |
| 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. | 6 months from baseline |
| 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. | 6 months from baseline |
| 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. | 6 months from baseline |
| 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. | 6 months from baseline |
| 6 months from baseline |
| Lost to Follow-up |
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| Patient with Dementia Died |
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| Patient with dementia were not administered surveys |
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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. |
| BG002 | STAR-C VTF - Caregiver | Randomized Caregivers are offered:
|
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
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. |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Demographic data was collected from the patient with dementia's medical record and the caregiver demographic data was collected at a later date; we were not able to record all caregiver demographic data. | 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. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Demographic data was collected from the patient with dementia's medical record and the caregiver demographic data was collected at a later date; we were not able to record all caregiver demographic data. | 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. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Demographic data was collected from the patient with dementia's medical record and the caregiver demographic data was collected at a later date; we were not able to record all caregiver demographic data. | 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. | Count of Participants | Participants |
|
| Region of Enrollment | Demographic data was collected from the patient with dementia's medical record and the caregiver demographic data was collected at a later date. Although we were not able to collect all demographic data from the caregivers, all resided in the same region. | Number | participants |
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| Caregiver Mastery Scale | The Caregiver Mastery Scale 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. This scale was only used with caregivers and were reported as the total score. | The Caregiver Mastery Scale is only completed by the caregiver. | Mean | Standard Deviation | units on a scale |
|
| Revised Memory and Problem Behavioral Checklist | Scale used to measure caregiver's observation of any memory or behavior issues over the past week. The potential range of the scale is 0-96 with higher scores reflecting more problems with memory or behaviors observed in the patient with dementia. This scale was only used with caregivers and were reported as the total score. | The Revised Memory and Problem Behavioral Checklist is only completed by the caregiver. | Mean | Standard Deviation | units on a scale |
|
| Kingston Caregiver Stress | This measure captures the caregiver's self-reported level of stress. Potential range of 10-50, with higher values indicating higher stress in the caregiver. This scale was only used with caregivers and were reported as the total score. | The Kingston Caregiver Stress is only completed by the caregiver. | Mean | Standard Deviation | units on a scale |
|
| RMBPC, Depression subscale | The Revised Memory and Behavior Problems Checklist, Depression subscale measure depression symptoms of the patient with dementia as reported by the caregiver. The sub scale range is 0-36; with a higher score indicating worse depression symptoms. | The RMBPC, Depression subscale is only completed by the caregiver. | Mean | Standard Deviation | units on a scale |
|
| Functional Activities Questionnaire | The Functional Activities Questionnaire measures the patient with dementia's dependency on their caregiver for daily activities as reported by the caregiver. Total range is 0-30; with a higher score indicating a higher dependence on the caregiver by the patient with dementia. | The Functional Activities Questionnaire is only completed by the caregiver. | Mean | Standard Deviation | units on a scale |
|
| Dementia Severity Rating Scale | The Dementia Severity Rating Scale measures the severity of dementia as observed by a caregiver in the patient with dementia. The subscale ranges are: A higher subscale score indicates worse dementia symptom.
| The Dementia Severity Rating Scale is completed by the caregiver to report the patient with dementia's severity rating for each subscale. | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| STAR-C VTF |
Randomized Person Living With Dementia - Caregiver dyads are offered:
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months from baseline |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline caregiver mastery at 6 months. |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months from baseline |
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| 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. | Posted | Count of Participants | Participants | 8 weeks from baseline |
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| 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. | Posted | Count of Participants | Participants | 6 months from baseline |
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| 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. | 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. | Posted | Number | dyads | 8 weeks from baseline |
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| 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. | 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. | Posted | Number | Inpatient Visits | End of follow-up (6 months) |
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| 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. | 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. | Posted | Number | Primary Care Visits | End of follow-up (6 months) |
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| 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. | 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. | Posted | Number | Emergency Department Visits | End of follow-up (6 months) |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | Average number of prescription fills | After 8 weeks in the study |
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| Secondary | Antipsychotic Prescription Refill Rate for Patient With Dementia | Refill rates after initial medication dispensing, using automated system pharmacy data | 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. | Posted | Mean | 95% Confidence Interval | Average number of prescription refills | 8 weeks after initial prescription |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months from baseline |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months from baseline |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months from baseline |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months from baseline |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months from baseline |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months from baseline |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months from baseline |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months from baseline |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months from baseline |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months from baseline |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months from baseline |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months from baseline |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months from baseline |
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| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | 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. | 2 | 32 | 0 | 32 | 0 | 32 |
| EG002 | STAR-C VTF - Caregiver | Randomized Caregivers are offered:
| 0 | 35 | 0 | 35 | 0 | 35 |
| EG003 | 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. | 2 | 35 | 0 | 35 | 4 | 35 |
| Mechanical Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Difficulty Waking | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Distress | Psychiatric disorders | Non-systematic Assessment |
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Not provided
Not provided
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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