NCT04335110: STELLA

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

Completed NA Results posted Last updated 23 January 2024

What this trial tests

NA trial testing STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias) in Dementia in 28 participants. Completed in 15 June 2023.

Timeline

24 March 2021

Primary endpoint
1 June 2023

15 June 2023

Quick facts

Lead sponsor	Oregon Health and Science University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	28
Start date	24 March 2021
Primary completion	1 June 2023
Estimated completion	15 June 2023
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Dementia — all drugs for Dementia →
• Alzheimer Disease — all drugs for Alzheimer Disease →
• Caregiver Burnout — all drugs for Caregiver Burnout →
• Family Members — all drugs for Family Members →

Sponsor

Oregon Health and Science University

Who can join

18 and older, any sex, with Dementia or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Revised Memory and Behavior Problems Checklist Primary · The RMBPC is assessed 1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)

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.

RMPBC, F Pre

Group	Value	95% CI
Intervention	NA	± NA
Care Recipients	41.5	± 12

RMBPC, F, Post RMBPC, F, post

Group	Value	95% CI
Intervention	NA	± NA
Care Recipients	39.5	± 13.9

RMBPC, R, Pre

Group	Value	95% CI
Intervention	27.5	± 14.9
Care Recipients	NA	± NA

RMBPC, R, Post

Group	Value	95% CI
Intervention	24.7	± 13
Care Recipients	NA	± NA

Center for Epidemiological Studies Depression Scale Primary · 1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)

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)

CESD Pre

Group	Value	95% CI
One Arm Only (Caregivers)	9.9	± 7.2

CESD Post

Group	Value	95% CI
One Arm Only (Caregivers)	9.5	± 6.7

Desire to Institutionalize (DTI) Scale Secondary · Measured at study entry only

Care partner intention to place person with dementia in care facility. This only applies to caregivers.

Group	Value	95% CI
Desire to Institutionalize	11
Desire to Institutionalize	1
Desire to Institutionalize	1

Marwit Meuser Caregiver Grief Index Secondary · 1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)

Caregiver anticipatory grief. Range is 0-90. Higher scores indicate worse grief. This only applies to the caregivers.

Pre intervention

Group	Value	95% CI
MMCGI Pre	60.9	± 14.5

Post intervention

Group	Value	95% CI
MMCGI Pre	58.9	± 12.6

Feasibility and Participant Acceptability Secondary · Measured only once by caregivers 1 week after 8-week intervention

Measures how much participants find the intervention acceptable and feasible. This only applies to caregivers.

It was easy for me to attend STELLA Visits

Group	Value	95% CI
Experience Survey	12

I could talk with the STELLA Guide easily and openly

Group	Value	95% CI
Experience Survey	13

I feel confident that I can use STELLA skills ot manage upsetting behaviors

Group	Value	95% CI
Experience Survey	13

I felt my privacy was respected during the STELLA visits

Group	Value	95% CI
Experience Survey	13

I felt comfortable discussing sensitive topics with my Guide

Group	Value	95% CI
Experience Survey	13

Comfortable talking with other participants

Group	Value	95% CI
Experience Survey	13

Easy to find activity for Care recipient

Group	Value	95% CI
Experience Survey	11

Good Technical support

Group	Value	95% CI
Experience Survey	13

Quality of Life in Alzheimer's Disease (QOL-AD) Scale Secondary · 1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)

Quality of life for participants, both for caregivers and persons with dementia. The measure consists of 13 items, rated on a four point scale, with 1 being poor and 4 being excellent. Total scores range from 13 to 52, higher scores are better

QoL Pre

Group	Value	95% CI
Caregivers	37.1	± 5.3
Care Recipients	33.3	± 7.7

QoL Post

Group	Value	95% CI
Caregivers	35.5	± 6.2
Care Recipients	34	± 7.8

Sleep Duration Secondary · 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)

Digital behavioral biomarker for effective impact of care on care partner sleep. Measured via electronic sleep mat

pre intervention

Group	Value	95% CI
Care Partners	7.9	± 1.5
Care Recipients	8.9	± 1.8

post intervention

Group	Value	95% CI
Care Partners	7.8	± 1.8
Care Recipients	9.2	± 1.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Duration of study participation (about 1.3 years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention

Serious: 0/14 (0%)

Deaths: 0/14

Care Recipients

Serious: 3/14 (21%)

Deaths: 3/14

Serious adverse events (6 terms)

Reaction	System	Intervention	Care Recipients
Hospitalizaton: Fall	Musculoskeletal and connective tissue disorders	—	—
Hospitalization	Respiratory, thoracic and mediastinal disorders	—	—
Hospitalization GI	Gastrointestinal disorders	—	—
Hospitalization: Agitation	Psychiatric disorders	—	—
Death	Nervous system disorders	—	—
Death	Nervous system disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Intervention	Care Recipients
care partner burden	Psychiatric disorders	—	—
COVID	Respiratory, thoracic and mediastinal disorders	—	—
Fall	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Hospitalizaton: Fall, Hospitalization, Hospitalization GI, Hospitalization: Agitation, Death, Death.

Data from ClinicalTrials.gov NCT04335110 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Remote Passive Sensing of Older Adults' Activities and Function: User-Centered Design Considerations for Behavioral Interventions Conducted in the Home Setting.
   Miller LM, Kaye J, Lindauer A, Au-Yeung WM, et al · · 2024 · cited 3× · PMID 39423003 · DOI 10.2196/54709
2. Ascertaining Out-of-Pocket Costs of Dementia Care: Feasibility Study of a Web-Based Weekly Survey.
   Dawson WD, Mattek N, Gothard S, Kaye J, et al · · 2024 · cited 2× · PMID 39321453 · DOI 10.2196/56878