Alzheimer Disease Clinical Trial
— STAR-C-VTFOfficial title:
STAR Caregivers - Virtual Training and Follow-up
Verified date | January 2024 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Washington Health Research Institute | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | National Institute on Aging (NIA), University of Washington |
United States,
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. |
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