N/A
N=28
Assessing Acceptability, Cost, and Efficacy of STELLA-Support Via Technology
Dementia · Alzheimer Disease · Caregiver Burnout · Family Members
Bottom Line
View on ClinicalTrials.gov: NCT04335110 ↗Enrolled (actual)
28
Serious AEs
10.7%
Results posted
Jan 2024
Primary outcome: Primary: Revised Memory and Behavior Problems Checklist — NA; 41.5; NA; 39.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Revised Memory and Behavior Problems Checklist |
NA; 41.5; NA; 39.5; 27.5; NA | — |
| PRIMARY Center for Epidemiological Studies Depression Scale |
9.9; 9.5 | — |
| SECONDARY Desire to Institutionalize (DTI) Scale |
11; 1; 1 | — |
| SECONDARY Marwit Meuser Caregiver Grief Index |
60.9; 58.9 | — |
| SECONDARY Feasibility and Participant Acceptability |
12; 13; 13; 13; 13; 13 | — |
| SECONDARY Quality of Life in Alzheimer's Disease (QOL-AD) Scale |
37.1; 33.3; 35.5; 34 | — |
| SECONDARY Sleep Duration |
7.9; 8.9; 7.8; 9.2 | — |
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.
Eligibility Criteria
Care Recipient Inclusion:
- 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)
Care Recipient Exclusion:
- 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.
Care Partner Inclusion:
- 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
Care Partner Exclusion:
- 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
Inclusion for Care Recipient and Care Partner:
Participate in Oregon Roybal Center for CAre Support Translational Research Advantaged by Integrating Technology (ORCASTRAIT) (IRB#20236) Participant in the ORCASTRAIT study (IRB # 20236)
Data sourced from ClinicalTrials.gov (NCT04335110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.