STAR Caregivers - Virtual Training and Follow-up

Alzheimer Disease Clinical Trial

— STAR-C-VTF  

Official title:

STAR Caregivers - Virtual Training and Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04271046
• Other study ID #: 1347434
• Secondary ID: 1R01AG061926-01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 21, 2023

Study information

• Verified date: January 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 21, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Caregiver inclusion criteria:

• Aged = 21 years

• Lives with person with dementia or within 8 miles

• Provides at least 8 hours of care per week

• Able to read and speak English

• 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 with no siblings

• Unable to read and speak in 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Caregiver Burden
• Caregiver Burnout
• Dementia

Intervention

Behavioral:
• STAR-C-VTF
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.
• Control
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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute on Aging (NIA), University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Study Participation Rate	We will report study participation rates by study arm at the end of training	8 weeks from baseline
Other	Response Rates for Surveys	We will report survey response rates by study arm at the end of the trial.	8 weeks from baseline
Other	Number of Dyads Who Complete 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
Other	Number of Primary Care Visits	Measured as the number of visits per eligible study participant during the study period.	End of follow-up (6 months)
Other	Number of Urgent Care Visits	Measured as the number of visits per eligible study participant during the study period.	End of follow-up (6 months)
Other	Number of Emergency Department Visits	Measured as the number of visits per eligible study participant during the study period.	End of follow-up (6 months)
Other	Number of secure messages	Count of the number of caregiver-initiated secure messages to the coach	End of follow-up (6 months)
Other	Time per home visit	Total time spent traveling to/from and conducting the home-based visit at baseline	baseline only
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.	Change from baseline caregiver burden at 8 weeks.
Primary	Use of antipsychotic medications	Refill rates after initial medication dispensing, using automated system pharmacy data	6 months after initial prescription
Secondary	Change in Caregiver depression	Self-reported caregiver depression assessed by the 8-item Patient Health Questionnaire (PHQ-8).; The PHQ-8 is am eight-item measure of depression that assesses symptoms over the last two weeks. The total sum of the 8 responses from the PHQ-8 ranges between 0 and 24 with higher scores indicating worse outcome. In general, a total of 10 or above is suggestive of the presence of depression.	Baseline, 8 week and 6 month follow up
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.	Change from baseline caregiver mastery at 8 weeks.