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

NCT06460012 | Recruiting

• 1 other identifier: STUDY00025741
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burden

Keywords

caregivers; dementia; RMBPC; caregiver support

Outcome Measures

Primary Outcomes (3)

• Revised Memory and Behavior Problems Checklist (RMBPC)

  The primary outcome variable, reactivity, will be assessed with the RMBPC, which measures the frequency of care recipient behavioral symptoms and care partner reactions to these behaviors. The RMBPC was chosen because it aligns with our theoretical foundation that assumes burden is a result of care partner reactions to behavioral symptoms. The RMBPC is a 29-item caregiver report measure, 5-point Likert scale with frequency measuring from 0 (never occurred) to 4 (daily or more often) and reactivity measuring from 0 (not at all) to 4 (extremely) for a total score between 0-116 for each subscale (frequency subscale and reactivity subscale). Higher scores indicate greater behavioral problems.

  Week 1, Week 8, Week 16, Week 24

• Feasibility of STELLA-R Intervention

  We will assess the feasibility of implementing STELLA-R across Oregon, Washington and Idaho. We will analyze metadata from the STELLA-R website to assess care partner usage of intervention materials. We will assess data from the surveys to characterize the sample, assess program acceptability, and measure treatment fidelity. We will compare demographic information, computer use, health-care usage, behavioral symptom frequency, medication use, care partner reactivity, burden and depression.

  10 months

• Acceptability of STELLA-R Intervention

  For acceptability, we will utilize the STELLA-R Experience Survey which is a 16-item survey on satisfaction, privacy, and ease of use. We will analyze the STELLA-R Experience Survey results using descriptive statistics. We will identify themes of acceptance, or lack thereof, of STELLA-R and the underpinnings of their impressions.

  Week 24

Secondary Outcomes (13)

• Fortinsky's Measurement of Family Care Partner Self-Efficacy for Managing Dementia

  Week 1, Week 8, Week 16, Week 24

• Preparedness for Caregiving Scale

  Week 1, Week 8, Week 16, Week 24

• Ten-Item Personality Inventory (TIPI)

  Week 1

• Personalized Target Behavior Survey

  Week 1, Week 8

• Emotional and Physical Strain

  Weekly for 6 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Behavioral: STELLA-R Curriculum; Behavioral: Unrestricted Access; Behavioral: Limited Access

Waitlist Control Group

ACTIVE COMPARATOR

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

Behavioral: STELLA-R Curriculum; Behavioral: Unrestricted Access; Behavioral: Limited Access

Interventions

STELLA-R Curriculum 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.

Experimental Group; Waitlist Control Group

Unrestricted Access BEHAVIORAL

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

Also known as: Post-Intervention Phase, Review Phase

Experimental Group; Waitlist Control Group

Limited Access 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.

Also known as: Restricted Access

Experimental Group; Waitlist Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• The Hart Family Foundation: collaborator

Study Sites (1)

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

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Caregiver Burden; Dementia

Condition Hierarchy (Ancestors)

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

Study Officials

• Allison Lindauer, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Lindauer, PhD

CONTACT

(503) 449-8151; lindauer@ohsu.edu

Christina Zonker, BA

CONTACT

(503) 816-8310; zonkerc@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Care partners will be randomized into one of two groups. Care partners will be blinded to which group they are in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 14, 2024
• Study Start: July 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Once data is available, it will be available indefinitely.
• Access Criteria: Requests need to be made to the PI at the Oregon Alzheimer's Disease Research Center (OARDC). A short data request form will need to be submitted.

Locations

US (1)