Clinical trial NCT06460012: Support Via Technology: Living and Learning With Advancing Dementia-REVISED
Official title: Support Via Technology: Living and Learning With Advancing Dementia-REVISED
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver Burden
Keywords: caregivers
dementia
RMBPC
caregiver support
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: The Hart Family Foundation
First posted: 2024-06-14
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Care partners will participate in a self-directed, 8-week online course via the STELLA-R website, followed by 8-weeks of unrestricted access to the website, with 8 weeks of restricted access. One group will receive the 8-week online course followed by the 8-week unrestricted access immediately after enrolling. The other group will receive the 8-week online course and 8-week unrestricted access 2 months after enrolling.
Primary purpose: SUPPORTIVE_CARE

Brief summary: STELLA-R is a multicomponent, self-directed, online intervention designed to facilitate effective management of behavioral and psychological symptoms that are common in many types of dementia. The curriculum instructs care partners to use the ABC approach, a cognitive behavioral technique that teaches care partners to describe a Behavior, then consider the Activators and Consequences of a care recipient behavior. The goal of this intervention is to reduce care partner burden and decrease reactivity to upsetting behaviors.

Detailed description: Providing care for a family member with Alzheimer's disease and related dementias (ADRD, aka, "dementia") is both rewarding and risky. Care partners exposed to chronic stress, often over years, are susceptible to physical and psychological ailments. Dementia involves neurodegeneration and those affected typically depend on family members for support and physical care. The "care partners" for those with dementia often experience concerning psychological and physical outcomes due to the demands of caregiving. No matter what type of dementia, most care partners experience some burden. The burden is often related to the behavioral symptoms that most people with dementia experience.

Care partners for those with dementia experience burden, grief, exhaustion and physical ailments. Programs for these care partners are more available. Effective interventions that reduce care partner burden and health risks are also available, but various factors impede participation, including distance, cost, behavioral symptoms of dementia, stigma and social anxiety. Recognizing the need to reduce barriers to access, scientists have turned to internet-based interventions.

The STELLA suite of research studies addresses the need for easily accessible, effective interventions designed to reduce burden in care partners for those with dementia. These studies examine the acceptability, feasibility, and efficacy of interventions modeled on Teri's psychoeducational behavior change intervention. We have completed two pilot studies for care partners for those with dementia using interventions with the STELLA-R precursor. These studies found early efficacy and acceptability for the intervention. We are currently testing a STELLA intervention which uses objective, technology-based assessments (OHSU IRB # 19306) and another, larger study which tests a STELLA intervention with a large national sample (OHSU IRB # 22288; NIA R01AG067546). In addition, with funding from the Association for Frontotemporal Degeneration (AFTD) we tested a similar intervention (STELLA-FTD) for care partners caring for a family member with frontotemporal dementia (OHSU IRB # 22721).

In all STELLA studies care partners work with professional guides to use the ABC analytic approach to describe a distressing behavior, then identify its activators and consequences. With this information, care partners can develop plans to reduce behavioral symptoms. In this proposed study, we will assess an online version of Tele-STELLA.

STELLA-R is informed by the World Health Organization (WHO) guidance to include rehabilitation science in dementia care to facilitate effective management of the advancing behavioral, communication, physical and social changes that come with progressive neurodegenerative dementias (e.g., Alzheimer's disease, frontotemporal degeneration, Lewy Body dementia). Grounded in self-efficacy theory and foundational research, STELLA-R will train care partners to address current behavioral symptoms and prepare for future ones.

The specific aims of this study are:

Aim 1. Assess feasibility and acceptability of STELLA-R

Aim 2. Compare the efficacy of STELLA-R in reducing care partner reactivity to dementia-related behavioral symptoms between two groups.

Eligibility criteria: Inclusion Criteria:

* Adult caring for family member with ADRD
* Age of 18 years or older
* Speaks and understands English to be able to participate in intervention
* Owns a telephone (smartphone, cell phone or landline)
* Has email and mailing address to receive study materials and surveys
* Provides informed consent to participate in the research
* Lives in Oregon, Washington or Idaho
* Identifies two or more behavioral symptoms that are distressing to them (care partner)

Exclusion Criteria:

* Vision problems severe enough to prevent participation
* Unwilling or unable to adequately follow study instructions and participate in study procedures

Primary outcomes:
measure: Revised Memory and Behavior Problems Checklist (RMBPC)
timeFrame: Week 1, Week 8, Week 16, Week 24
measure: Feasibility of STELLA-R Intervention
timeFrame: 10 months
measure: Acceptability of STELLA-R Intervention
timeFrame: Week 24
Secondary outcomes:
measure: Fortinsky's Measurement of Family Care Partner Self-Efficacy for Managing Dementia
timeFrame: Week 1, Week 8, Week 16, Week 24
measure: Preparedness for Caregiving Scale
timeFrame: Week 1, Week 8, Week 16, Week 24
measure: Ten-Item Personality Inventory (TIPI)
timeFrame: Week 1
measure: Personalized Target Behavior Survey
timeFrame: Week 1, Week 8
measure: Emotional and Physical Strain
timeFrame: Weekly for 6 months
measure: Healthcare Use
timeFrame: Weekly for 6 months
measure: Zarit Burden Interview
timeFrame: Weekly for 6 months
measure: The Neuropsychiatric Inventory (NPI-Q)
timeFrame: Week 1, Week 8, Week 16, Week 24
measure: Placement Plan Scale
timeFrame: Week 1, Week 8, Week 16, Week 24
measure: Use of Professional Services
timeFrame: Week 1, Week 8, Week 16, Week 24
measure: Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
timeFrame: Week 1, Week 24
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Week 1, Week 24
measure: ABC Plans
timeFrame: Week 8, Week 16, Week 24
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University, Layton Aging and Alzheimer's Disease Research Center
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Allison Lindauer, PhD
role: PRINCIPAL_INVESTIGATOR
References: