Assessing Acceptability, Cost, and Efficacy of STELLA-Support Via Technology

NCT04335110 | Completed Results

• 2 other identifiers: STUDY000193062P30AG024978-16
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

STELLA (Support via Technology Living and Learning with Advancing Alzheimer's disease and related dementias) is a multicomponent video-conference based intervention that aims to help family members caring for persons of dementia as well the person with dementia. The goal of this intervention is to reduce upsetting behaviors and care partner burden. Caring for a family member with Alzheimer's disease or related dementia (ADRD) can come with many burdens that affect not only the care partners' physical and psychological health but also barriers to access. Due to factors such as distance and cost, Internet-based interventions like STELLA are a great alternative to in-person interventions because it can still address the specific needs of families living with dementia. The hypothesis of this study is that care partners will show significant improvements in burden and depression following the intervention. STELLA is also designed to facilitate effective management of behavioral and psychological symptoms of dementia (BPSD). To accomplish this, up to 40 care partners and their 40 care recipients with Alzheimer's disease and related dementias will participate in an 8-week intervention with the support of a Guide (e.g. nurse or social worker). However, the primary focus of this study is on care partners. With the support of a Guide, care partners will identify strategies to address upsetting behaviors in the moderate to late stages of dementia. More specifically, a Guide will help care partners identify and modify distressing behavioral symptoms of dementia. Based on quantitative and qualitative approaches, the effect of the intervention on care partner affective symptoms, including depression and burden, as well as quality of life for both the care partner and the person with dementia will be assessed.

Conditions

Dementia; Alzheimer Disease; Caregiver Burnout; Family Members

Outcome Measures

Primary Outcomes (2)

• Revised Memory and Behavior Problems Checklist

  Care recipient frequency of behaviors and caregiver reactions to behavioral symptoms. The scale measures how often a behavior occurs (Frequency, "F") and how much the caregiver reacts to it (Reactivity, "R"). Range for both scales is 0-96, lower scores are better. Subscales are not combined.

  The RMBPC is assessed 1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)

• Center for Epidemiological Studies Depression Scale

  Caregiver depression symptoms, Range 0-30, lower scores indicate less depression (better). Depression is only measured for the caregivers, not the care recipients with dementia (only 1 group)

  1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)

Secondary Outcomes (5)

• Desire to Institutionalize (DTI) Scale

  Measured at study entry only

• Marwit Meuser Caregiver Grief Index

  1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)

• Feasibility and Participant Acceptability

  Measured only once by caregivers 1 week after 8-week intervention

• Quality of Life in Alzheimer's Disease (QOL-AD) Scale

  1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)

• Sleep Duration

  Measures sleep from enrollment to study end. Mean sleep hours one week prior to intervention (pre) and one week after intervention (post). Measured in hours (units on a scale)

Study Arms (1)

Intervention

OTHER

Care Partners and Persons with Dementia. Up to 40 Care Partners and their 40 care-recipients with ADRD will participate in this study. The primary focus of this study is on Care Partners, however, we will gather subjective and objective data on participants with Alzheimer's Disease and Related Dementias (ADRD) to assess the effect of the intervention on Care Partner affective responses to caregiving and quality of life for both. STELLA participants will be recruited from the existing cohort of patients, and their Care Partners, who are enrolled in the Oregon Roybal Center for CAre Support Translational Research Advantaged by Integrating Technology) ORCASTRAIT Life Laboratory (OSLL).

Behavioral: STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias)

Interventions

STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias) BEHAVIORAL

STELLA consists of 8 sessions: 4 sessions one-to-one, with the Care Partner and a Guide, and then 4 sessions with one Guide with up to four Care Partners (total small group will include as few as two and as many as 4 Care Partners) Each weekly session takes about 1 hour. The first four sessions allow for development of the Care Partner-Guide working relationship. In these sessions, the Care Partners identify behaviors (both the person with dementia's and the Care Partner's) which are upsetting to the family. Care Partners will be taught to use an Activator, Behavior, Consequence (ABC) approach to identify activators of behaviors, the behaviors, and consequences of the behaviors. After they identify the ABCs, they will develop a plan to address the behavior and then test it. After the four one-to-one sessions, Care Partners will meet in small groups with a Guide. Effective communication strategies, engagement in pleasant events, and coping will be addressed.

Intervention

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Alzheimer's Disease and Related Dementias (ADRD), moderate to late stages
• Exhibits 2 or more behaviors listed on Revised Memory and Behavioral Problems (RMBP) 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 Care Partner training
• Early stage dementia, as defined by a Montreal Cognitive Assessment (MoCA) of about 15/30 or higher.
• Adult caring for family member with ADRD
• Lives with care recipient OR spends at least 4 hours/week with care recipient
• Age of 18 years or older
• Speak English
• Own a computer/device with a reliable internet connection and compatible operating system
• Unable to find activity for care recipient during training which would allow Care Partner to work privately, one-on-one during training
• Completed similar telehealth intervention within the last year
• Hearing and vision problems severe enough to prevent participation
• Unwilling or unable to adequately follow study instructions and participate in study procedures
• Participate in Oregon Roybal Center for CAre Support Translational Research Advantaged by Integrating Technology (ORCASTRAIT) (IRB#20236) Participant in the ORCASTRAIT study (IRB # 20236)

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

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

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Dawson WD, Mattek N, Gothard S, Kaye J, Lindauer A. Ascertaining Out-of-Pocket Costs of Dementia Care: Feasibility Study of a Web-Based Weekly Survey. JMIR Form Res. 2024 Sep 25;8:e56878. doi: 10.2196/56878.

  PMID: 39321453 DERIVED

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Caregiver Burden

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

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

lindauer@ohsu.edu

15034946976

Study Officials

• Walter Dawson, 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

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: April 6, 2020
• Study Start: March 24, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 15, 2023
• Last Updated: January 23, 2024
• Results First Posted: January 23, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available 1/2021, 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)