Using Technology to Support Care Partners for Persons With Alzheimer's Disease: Tele-STELLA

NCT04627662 | Completed Results

• 1 other identifier: STUDY00022288
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test a revised psychoeducational intervention to help Care Partners for family members with dementia understand and reduce the distressing behaviors that come with progressive dementia. Tele-STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias) is a multicomponent videoconference-based intervention designed to facilitate effective management of behavioral and psychological symptoms common to the later stages of dementia. In the Tele-STELLA intervention, professionals ("Guides") meet with family members ("Care Partners") who care for persons with dementia. Working together, the Care Partners and Guides identify strategies to address upsetting behaviors. The goal of this intervention is to reduce upsetting behaviors and, thus, Care Partner burden.

Conditions

Dementia; Alzheimer Disease; Caregiver Burnout; Family Members

Outcome Measures

Primary Outcomes (2)

• Revised Memory and Behavior Problems Checklist, Reactivity Subscale

  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.

  Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

• Revised Memory and Behavior Problems Checklist, Frequency Subscale

  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.

  Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

Secondary Outcomes (7)

• Marwit Meuser Caregiver Grief Index-Short Form

  Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

• Quality of Life-Alzheimer's Disease (QoL-AD), Care Partner

  Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

• Center for Epidemiologic Studies Depression Scale, 10-item (CES-D 10)

  Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

• 4-item Zarit Burden Interview (ZBI-4)

  Baseline (first weekly survey at study enrollment, prior to intervention).

• Ten Item Personality Inventory (TIPI)

  Baseline (1 week prior to Constellation intervention start)

Study Arms (1)

Care Partners

OTHER

Based on previous work, we will recruit up to 75 Care Partners and their 75 care recipients with dementia. This allows for 20% attrition. We will recruit participants from Alzheimer's Disease Research Centers (ADRCs) and other national locations.

Behavioral: Tele-STELLA

Interventions

Tele-STELLA BEHAVIORAL

Tele-STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias) is a multicomponent videoconference-based intervention designed to facilitate effective management of behavioral and psychological symptoms common to the later stages of dementia.

Care Partners

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ADRD, moderate to late stages as defined by family member (Box 1)
• Exhibits 2 or more behaviors listed on RMBPC that are bothersome to the Care Partner and occur 3 or more times/week at study enrollment
• Family member of Care Partner (this can be a relative, spouse or close kin that is considered family)

You may not qualify if:

• Dementia not related to ADRD
• Unable to leave Care Partner during Tele-STELLA sessions
• Early stage dementia, as defined by family member
• Adult caring for family member with ADRD
• Provides care for at least 4 hours/week
• 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 mailing address to receive computer and study materials
• Provides informed consent to participate in the Research
• Unable to find activity for care recipient during Tele-STELLA sessions to allow Care Partner to work privately with Guide and other Care Partners.
• Completed similar telehealth intervention within the last year
• Hearing and/or 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

Study Sites (1)

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

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Lindauer A, Messecar D, McKenzie G, Gibson A, Wharton W, Bianchi A, Tarter R, Tadesse R, Boardman C, Golonka O, Gothard S, Dodge HH. The Tele-STELLA protocol: Telehealth-based support for families living with later-stage Alzheimer's disease. J Adv Nurs. 2021 Oct;77(10):4254-4267. doi: 10.1111/jan.14980. Epub 2021 Jul 20.

  PMID: 34288013 BACKGROUND

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Caregiver Burden

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Allison Lindauer
• Organization: Oregon Health & Science University

lindauer@ohsu.edu

(503) 494-6976

Study Officials

• Allison Lindauer, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Care partners will participate in 2, 8-week sessions to learn about distressing behavioral symptoms in dementia.

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: November 13, 2020
• Study Start: May 14, 2021
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: March 20, 2026
• Results First Posted: March 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available 1/2026, available indefinitely
• Access Criteria: Requests need to made to the PI at the Oregon Alzheimer's Disease Research Center (OARDC). A short data request form will need to be submitted to the OADRC

Locations

US (1)