Alzheimer DiseaseSTAR-C-VTFNCT04271046
STAR Caregivers - Virtual Training and Follow-up
A study testing STAR-C-VTF in people with Alzheimer Disease and Dementia, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia, Caregiver Burnout
- What is being tested?
- STAR-C-VTF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 21 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Current Criteria:
Investigators will identify and recruit Person with Dementia-Caregiver dyads in which the person with dementia has has made a healthcare visit in the last week where a diagnosis of Alzheimer's Disease or related dementia was recorded. Because we will enroll dyads, there are inclusion/exclusion criteria for both.
Participants
Persons with dementia inclusion criteria:
Aged ≥ 65 years Confirmed diagnosis of Alzheimer's Disease related disorders (ADRD) from the patient Electronic Health Record (EHR) or primary care physician KP members for a minimum of 180 days prior to the index visit date. Expected to live >= 6 months from enrollment
Persons with dementia exclusion criteria:
- A diagnosis of bipolar disorder or schizophreniform disorder
- The primary care physician's opinion is that the person with dementia is expected to live less than 6 months.
- Less that 65 years of age
- Primary language is not English (patient requires a translator).
Caregiver inclusion criteria:
- Aged ≥ 21 years
- Lives with person with dementia or within 8 miles
- Provides at least 8 hours of care per week
- Have access to a computer or other device where they can access MyChart, personal email, and websites to complete online training
- Use MyChart to email the doctors that care for the PWD they are caring for
Caregivers exclusion criteria:
- Diagnosis of Alzheimer's Disease or related disorders.
- Less than 21 years of age
- Are not the spouse, or adult child
- Unable to read and speak English
- Do not have access to a computer or other device where they can access MyChart, personal email, and websites to complete online training
- Do not use MyChart to email to doctors that care for the PWD they are caring for.
Previous Criteria:
Participants
The investigators will identify and recruit Person with Dementia-Caregiver dyads in which the person with dementia has filled a new prescription for an antipsychotic medication. Because we will enroll dyads, there are inclusion/exclusion criteria for both.
Persons with dementia inclusion criteria:
- Aged ≥ 65 years
- Diagnosis of Alzheimer's Disease related dementia (ADRD)
- A new prescription for an antipsychotic medication
- Living at home
- Expected to live >= 6 months from enrollment
Persons with dementia exclusion criteria:
- A diagnosis of bipolar disorder or schizophreniform disorder
- Living in an assisted living, skilled nursing facility, or memory facility
- The primary care physician's opinion is that the person with dementia is expected to live less than 6 months.
Caregiver inclusion criteria:
- Aged ≥ 21 years
- Lives with person with dementia or within 8 miles
- Provides at least 8 hours of care per week
Caregivers exclusion criteria:
- Diagnosis of Alzheimer's Disease or related disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease, Dementia, Caregiver Burnout
- Being tested
- STAR-C-VTF, Control
- Medical subject headings
- Alzheimer Disease, Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR-C-VTFBehavioural
- 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);
- 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;
- secure message support, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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:
* self-directed learning in which the caregiver will receive training materials delivered electronically through a web-based learning portal;
* one orientation phone visit with a coach;
* ongoing support from the coach via telephone and secure messaging in the web-portal.
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. Receives: Behavioral: STAR-C-VTF |
| 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline caregiver burden at 6 months.
Secondary outcomes (23)
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.
Measured: 6 months from baseline
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 May 2020
- Primary completion1 Sep 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Washington
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271046
- Sponsor's protocol ID
- 1347434
- Other IDs
- 1R01AG061926-01
- Acronym
- STAR-C-VTF
- Status last verified
- Jan 2025
- First submitted
- 16 Apr 2019
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STAR Caregivers - Virtual Training and Follow-up
- ClinicalTrials.gov ID
- NCT04271046
- Acronym / sponsor ID
- STAR-C-VTF / 1347434
- Conditions
- Alzheimer Disease, Dementia, Caregiver Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Washington
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Posted 4 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group- STAR-C-VTF | Experimental | Behavioral: STAR-C-VTFThis 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: * self-directed learning in which the caregiver will receive training materials delivered electronically through a web-based learning portal; * one orientation phone visit with a coach; * ongoing support from the coach via telephone and secure messaging in the web-portal. 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 | Behavioral: ControlOne 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAR-C-VTF1. 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. | Behavioural | Experimental Group- STAR-C-VTF |
| ControlOne 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. | Behavioural | Control |
Primary outcome
Change in Caregiver Burden
Time frame: 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.
23 secondary outcomes
Change in Caregiver Depression
Time frame: 6 months from baseline
Change in Caregiver Self-efficacy
Time frame: Change from baseline caregiver mastery at 6 months.
Kingston Caregiver Stress Scale
Time frame: 6 months from baseline
Number of Caregivers Who Responded to Surveys at 8-weeks
Time frame: 8 weeks from baseline
Number of Caregivers Who Responded to Surveys at 6-months
Time frame: 6 months from baseline
Number of Dyads Who Complete STAR-C VTF Online Training
Time frame: 8 weeks from baseline
Number of Inpatient Visits Had by Patient With Dementia
Time frame: End of follow-up (6 months)
Number of Primary Care Visits Had by Patient With Dementia
Time frame: End of follow-up (6 months)
Number of Emergency Department Visits Had by Patient With Dementia
Time frame: End of follow-up (6 months)
Antipsychotic Prescription Fills Rate for Patient With Dementia
Time frame: After 8 weeks in the study
Antipsychotic Prescription Refill Rate for Patient With Dementia
Time frame: 8 weeks after initial prescription
Dementia Severity Rating Scale (DSRS) - Memory
Time frame: 6 months from baseline
Dementia Severity Rating Scale (DSRS) - Speech and Language
Time frame: 6 months from baseline
Dementia Severity Rating Scale (DSRS) - Recognition of Family Members
Time frame: 6 months from baseline
Dementia Severity Rating Scale (DSRS) - Orientation to Time
Time frame: 6 months from baseline
Dementia Severity Rating Scale (DSRS) - Orientation to Place
Time frame: 6 months from baseline
Dementia Severity Rating Scale (DSRS) - Ability to Make Decisions
Time frame: 6 months from baseline
Dementia Severity Rating Scale (DSRS) - Social & Community Activity
Time frame: 6 months from baseline
Dementia Severity Rating Scale (DSRS) - Home Activities & Responsibilities
Time frame: 6 months from baseline
Dementia Severity Rating Scale (DSRS) - Personal Care - Cleanliness
Time frame: 6 months from baseline
Dementia Severity Rating Scale (DSRS) - Eating
Time frame: 6 months from baseline
Dementia Severity Rating Scale (DSRS) - Control of Urination and Bowels
Time frame: 6 months from baseline
Dementia Severity Rating Scale (DSRS) - Ability to Get From Place to Place
Time frame: 6 months from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAR-C-VTF in people with Alzheimer Disease and Dementia, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Caregiver Burden (time frame: Change from baseline caregiver burden at 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.