Support Via Technology: Living and Learning With Advancing Dementia-REVISED
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: STELLA-R Curriculum, Unrestricted Access, Limited Access.
- Who it may be relevant to
- Registry conditions: Caregiver Burden. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral 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 - Behavioral Unrestricted Access
Following the STELLA-R curriculum, care partners will receive 8 weeks of unrestricted access to all lessons and resources. - 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.
Primary outcome measures
- Revised Memory and Behavior Problems Checklist (RMBPC) [Time frame: Week 1, Week 8, Week 16, Week 24]
- Feasibility of STELLA-R Intervention [Time frame: 10 months]
- Acceptability of STELLA-R Intervention [Time frame: Week 24]
Secondary outcome measures (12)
- Fortinsky's Measurement of Family Care Partner Self-Efficacy for Managing Dementia [Time frame: Week 1, Week 8, Week 16, Week 24]
- Preparedness for Caregiving Scale [Time frame: Week 1, Week 8, Week 16, Week 24]
- Ten-Item Personality Inventory (TIPI) [Time frame: Week 1]
- Personalized Target Behavior Survey [Time frame: Week 1, Week 8]
- Emotional and Physical Strain [Time frame: Weekly for 6 months]
- Healthcare Use [Time frame: Weekly for 6 months]
- Zarit Burden Interview [Time frame: Weekly for 6 months]
- The Neuropsychiatric Inventory (NPI-Q) [Time frame: Week 1, Week 8, Week 16, Week 24]
- Placement Plan Scale [Time frame: Week 1, Week 8, Week 16, Week 24]
- Use of Professional Services [Time frame: Week 1, Week 8, Week 16, Week 24]
- Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) [Time frame: Week 1, Week 24]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: Week 1, Week 24]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Oregon Health & Science University, Layton Aging and Alzheimer's Disease Research Center — Portland
Identifiers
NCT: NCT06460012 · STUDY00025741