Support Via Technology: Living and Learning With Advancing Dementia-REVISED

NCT ID: NCT06460012

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-02
• Study Completion Date: 2026-12-01

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.

Conditions

Caregiver Burden

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

Care partners start the STELLA-R Curriculum immediately after enrollment.

Group Type: EXPERIMENTAL

STELLA-R Curriculum

Intervention Type: BEHAVIORAL

The STELLA-R curriculum is presented utilizing the ABC analytic approach to address care recipient's distressing behaviors. Using the scaffold of the ABC pyramid, they will receive video instructions on how to fully define the Behaviors they want to address by observing, describing, and writing about them. The care partners will learn to identify the Activators, the triggers for the behaviors. Next, care partners will learn to consider what happens after the behaviors, the Consequences. This is an 8-week self-directed, online weekly curriculum.

Unrestricted Access

Intervention Type: BEHAVIORAL

Following the STELLA-R curriculum, care partners will receive 8 weeks of unrestricted access to all lessons and resources.

Limited Access

Intervention Type: BEHAVIORAL

Experimental and Waitlist Control group will experience 8 consecutive weeks of limited access to the STELLA-R website and resources. Waitlist Control will experience this from Week 1 to Week 8 while the Experimental Group will reach this phase from Week 17 to Week 24.

Waitlist Control Group

Care partners start the STELLA-R Curriculum 8 weeks after enrollment.

Group Type: ACTIVE_COMPARATOR

STELLA-R Curriculum

Intervention Type: BEHAVIORAL

The STELLA-R curriculum is presented utilizing the ABC analytic approach to address care recipient's distressing behaviors. Using the scaffold of the ABC pyramid, they will receive video instructions on how to fully define the Behaviors they want to address by observing, describing, and writing about them. The care partners will learn to identify the Activators, the triggers for the behaviors. Next, care partners will learn to consider what happens after the behaviors, the Consequences. This is an 8-week self-directed, online weekly curriculum.

Unrestricted Access

Intervention Type: BEHAVIORAL

Following the STELLA-R curriculum, care partners will receive 8 weeks of unrestricted access to all lessons and resources.

Limited Access

Intervention Type: BEHAVIORAL

Experimental and Waitlist Control group will experience 8 consecutive weeks of limited access to the STELLA-R website and resources. Waitlist Control will experience this from Week 1 to Week 8 while the Experimental Group will reach this phase from Week 17 to Week 24.

Interventions

STELLA-R Curriculum

The STELLA-R curriculum is presented utilizing the ABC analytic approach to address care recipient's distressing behaviors. Using the scaffold of the ABC pyramid, they will receive video instructions on how to fully define the Behaviors they want to address by observing, describing, and writing about them. The care partners will learn to identify the Activators, the triggers for the behaviors. Next, care partners will learn to consider what happens after the behaviors, the Consequences. This is an 8-week self-directed, online weekly curriculum.

Intervention Type: BEHAVIORAL

Unrestricted Access

Following the STELLA-R curriculum, care partners will receive 8 weeks of unrestricted access to all lessons and resources.

Intervention Type: BEHAVIORAL

Limited Access

Experimental and Waitlist Control group will experience 8 consecutive weeks of limited access to the STELLA-R website and resources. Waitlist Control will experience this from Week 1 to Week 8 while the Experimental Group will reach this phase from Week 17 to Week 24.

Intervention Type: BEHAVIORAL

Other Intervention Names

Post-Intervention Phase; Review Phase; Restricted Access

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hart Family Foundation

UNKNOWN

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Allison Lindauer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison Lindauer, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University, Layton Aging and Alzheimer's Disease Research Center

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Allison Lindauer, PhD

Role: CONTACT

lindauer@ohsu.edu

(503) 449-8151

Christina Zonker, BA

Role: CONTACT

zonkerc@ohsu.edu

(503) 816-8310

Facility Contacts

Allison Lindauer, PhD

Role: primary

lindauer@ohsu.edu

503-494-6976

Other Identifiers

STUDY00025741

Identifier Type: -

Identifier Source: org_study_id