STAR Caregivers - Virtual Training and Follow-up

NCT04271046 | Completed Results DMC

• 2 other identifiers: 13474341R01AG061926-01
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness of a caregiver outreach, training, and support program for caregivers of people with dementia who are using antipsychotic medication to manage agitation/aggression. The Investigators will conduct a randomized trial of the caregiver program compared to a control group to measure differences in caregiver burden and discontinuation of antipsychotic medication use. The results will help in expanding access to and delivery of empirically supported behavioral health services for caregivers and people with dementia.

Conditions

Alzheimer Disease; Dementia; Caregiver Burnout

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (23)

• Change in Caregiver Depression

  6 months from baseline

• Change in Caregiver Self-efficacy

  Change from baseline caregiver mastery at 6 months.

• Kingston Caregiver Stress Scale

  6 months from baseline

• Number of Caregivers Who Responded to Surveys at 8-weeks

  8 weeks from baseline

• Number of Caregivers Who Responded to Surveys at 6-months

  6 months from baseline

Other Outcomes (1)

• Functional Activities Questionnaire (FAQ)

  6 months from baseline

Study Arms (2)

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.

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.

Behavioral: Control

Interventions

STAR-C-VTF BEHAVIORAL

1. One 60 minute baseline orientation phone visit with a coach to get verbal consent for participation in the study and to acquaint the caregiver with the STAR-VTF components of good dementia care; distribute printed educational material (and links to same material online); 2. Six 30-minute follow-up phone calls with the caregiver following each of the 6 learning modules to review STAR-VTF concepts, and further brainstorm strategies to modify identified activators and consequences with the objective of reducing behavioral symptoms; 3. secure message support, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months.

Experimental Group- STAR-C-VTF

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.

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may not qualify if:

• Participants
• 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
• 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).
• 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
• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute on Aging (NIA): collaborator
• University of Washington: collaborator

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Robert Penfold
• Organization: Kaiser Permanente Washington Health Research Institute

robert.b.penfold@kp.org

206-287-2232

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: February 17, 2020
• Study Start: May 1, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 21, 2023
• Last Updated: February 4, 2025
• Results First Posted: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)