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NCT Number: NCT06460012

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Allison Lindauer, PhD

CONTACT

[email protected]

503-494-6976

Allison Lindauer, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Unrestricted Access

Behavioral

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

Other names: Post-Intervention Phase, Review Phase

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.

Other names: Restricted Access

Primary outcomes

  1. Revised Memory and Behavior Problems Checklist (RMBPC)

    Time frame: Week 1, Week 8, Week 16, Week 24

    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.

  2. Feasibility of STELLA-R Intervention

    Time frame: 10 months

    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.

  3. Acceptability of STELLA-R Intervention

    Time frame: Week 24

    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.

Secondary outcomes

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

    Time frame: Week 1, Week 8, Week 16, Week 24

    Self-efficacy, the mediating variable, will be assessed using Fortinsky's measurement of family care partner self-efficacy for managing dementia. Fortinsky's assess the targets in STELLA-R: behavior symptom management and service use.

    Fortinsky's measurement is a 9-item Likert scale ranging from 1 (not at all certain) to 10 (very certain). Higher scores are associated with fewer depressive symptoms and fewer physical health symptoms.

  2. Preparedness for Caregiving Scale

    Time frame: Week 1, Week 8, Week 16, Week 24

    The Preparedness for Caregiving Scale is a 10-item Likert scale ranging from 0 (not at all prepared) to 4 (very well prepared). We will measure care partner preparedness for current and future challenges to test the effect of a group-based intervention.

  3. Ten-Item Personality Inventory (TIPI)

    Time frame: Week 1

    The Ten-Item Personality Inventory is a 10-item Likert scale measure to assess introversion and extraversion. Choices range from 1 (disagree strongly) to 7 (agree strongly) with reverse scoring on items 2, 4, 6, 8 and 10. Scoring on items are as follows: extraversion: 1, 6R; agreeableness: 2R, 7; conscientiousness: 3, 8R; emotional stability: 4R, 9; openness to experiences: 5, 10R. We will use this measure to test the effect of a group-based intervention.

  4. Personalized Target Behavior Survey

    Time frame: Week 1, Week 8

    The Personalized Target Behavior Survey measure frequency and reactivity of up to 3 personalized behaviors identified by care partners. We will collect data on the number of ABC plans each care partner writes on the Orbit weekly survey and the STELLA-R website.

  5. Emotional and Physical Strain

    Time frame: Weekly for 6 months

    The Orbit weekly survey will measure emotional and physical strain for caregivers.

  6. Healthcare Use

    Time frame: Weekly for 6 months

    The Orbit weekly survey will measure service use and medication use for behavioral symptoms.

  7. Zarit Burden Interview

    Time frame: Weekly for 6 months

    The Orbit weekly survey will include the Zarit Burden Interview, a 4-item caregiver report measuring care partner burden. This measure is a 5-point Likert scale with a range of 0 (never) to 4 (nearly always) with higher scores meaning greater burden.

  8. The Neuropsychiatric Inventory (NPI-Q)

    Time frame: Week 1, Week 8, Week 16, Week 24

    The NPI-Q with Caregiver Self-Efficacy Scale evaluates 12 behavioral disturbances in dementia. Each domain captures severity of BPSD and caregiver self-efficacy. Severity is rated 1 (mild) to 3 (severe) and self-efficacy is reverse scored from 4 (not at all confident) to 1 (very confident). This measure assesses self-efficacy in addressing specific behavioral symptoms.

  9. Placement Plan Scale

    Time frame: Week 1, Week 8, Week 16, Week 24

    1-item Likert scale assessment of plans for placement of family member with dementia. Care partners will rate their likelihood of moving their family member with dementia to another living arrangement from 1 (not at all likely) to 5 (very likely).

  10. Use of Professional Services

    Time frame: Week 1, Week 8, Week 16, Week 24

    A 7-item binary assessment of professional services used to address their family member with dementia's needs in the past 2 months. Care partners will answer Yes or No to using a: dietitian, elder care attorney, occupational therapist, physical therapist, psychologist, social worker, speech therapist, and healthcare professional.

  11. Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

    Time frame: Week 1, Week 24

    A 12-item assessment measuring mindfulness, distress, well-being, emotion-regulation, and problem-solving approaches. A Likert scale ranging from 1 (rarely/not at all) to 4 (almost always) with reverse scoring on items 2, 6 and 7.

  12. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Week 1, Week 24

    The PSQI contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available) that assesses self-rated sleep quality and disturbances over a 1-month time interval. Only self-rated questions are included in scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. A score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points. "0" indicating no difficulty and "21" indicating severe difficulties in all areas.

  13. ABC Plans

    Time frame: Week 8, Week 16, Week 24

    A 1-item measure to assess total quantity of ABC plans created. Options are 1 (1-3), 2 (4-6), 3 (7-9) or 4 (10 or more). Experimental group completes this measure on weeks 8, 16 and 24. Wait-list control group completes this measure on weeks 16 and 24.

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Lindauer, PhD

CONTACT

[email protected]

(503) 449-8151

Christina Zonker, BA

CONTACT

[email protected]

(503) 816-8310

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • The Hart Family Foundation

Registry information

Acronym: STELLA-R

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 14, 2024
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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