Support Via Technology: Living and Learning With Advancing Dementia-REVISED
NCT Number: NCT06460012
Acronym: STELLA-R
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Caregiver Burden
Interventions: BEHAVIORAL: STELLA-R Curriculum|BEHAVIORAL: Unrestricted Access|BEHAVIORAL: Limited Access
Sponsor: Oregon Health and Science University
Collaborators: The Hart Family Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 238
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-01
Completion Date: 2026-12-01
Locations: Oregon Health & Science University, Layton Aging and Alzheimer's Disease Research Center, Portland, Oregon, 97239, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Fortinsky's Measurement of Family Care Partner Self-Efficacy for Managing Dementia, 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., Week 1, Week 8, Week 16, Week 24|Preparedness for Caregiving Scale, 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., Week 1, Week 8, Week 16, Week 24|Ten-Item Personality Inventory (TIPI), 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., Week 1|Personalized Target Behavior Survey, 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., Week 1, Week 8|Emotional and Physical Strain, The Orbit weekly survey will measure emotional and physical strain for caregivers., Weekly for 6 months|Healthcare Use, The Orbit weekly survey will measure service use and medication use for behavioral symptoms., Weekly for 6 months|Zarit Burden Interview, 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., Weekly for 6 months|The Neuropsychiatric Inventory (NPI-Q), 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., Week 1, Week 8, Week 16, Week 24|Placement Plan Scale, 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)., Week 1, Week 8, Week 16, Week 24|Use of Professional Services, 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., Week 1, Week 8, Week 16, Week 24|Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), 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., Week 1, Week 24|Pittsburgh Sleep Quality Index (PSQI), 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., Week 1, Week 24|ABC Plans, 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., Week 8, Week 16, Week 24