Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460012
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-04
Brief Title:
Support Via Technology Living and Learning With Advancing Dementia-REVISED
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Support Via Technology Living and Learning With Advancing Dementia-REVISED
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STELLA-R
Brief 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
Detailed Description:
Providing care for a family member with Alzheimers disease and related dementias ADRD aka dementia is both rewarding and risky Care partners exposed to chronic stress often over years are susceptible to physical and psychological ailments Dementia involves neurodegeneration and those affected typically depend on family members for support and physical care The care partners for those with dementia often experience concerning psychological and physical outcomes due to the demands of caregiving No matter what type of dementia most care partners experience some burden The burden is often related to the behavioral symptoms that most people with dementia experience
Care partners for those with dementia experience burden grief exhaustion and physical ailments Programs for these care partners are more available Effective interventions that reduce care partner burden and health risks are also available but various factors impede participation including distance cost behavioral symptoms of dementia stigma and social anxiety Recognizing the need to reduce barriers to access scientists have turned to internet-based interventions
The STELLA suite of research studies addresses the need for easily accessible effective interventions designed to reduce burden in care partners for those with dementia These studies examine the acceptability feasibility and efficacy of interventions modeled on Teris psychoeducational behavior change intervention We have completed two pilot studies for care partners for those with dementia using interventions with the STELLA-R precursor These studies found early efficacy and acceptability for the intervention We are currently testing a STELLA intervention which uses objective technology-based assessments OHSU IRB 19306 and another larger study which tests a STELLA intervention with a large national sample OHSU IRB 22288 NIA R01AG067546 In addition with funding from the Association for Frontotemporal Degeneration AFTD we tested a similar intervention STELLA-FTD for care partners caring for a family member with frontotemporal dementia OHSU IRB 22721
In all STELLA studies care partners work with professional guides to use the ABC analytic approach to describe a distressing behavior then identify its activators and consequences With this information care partners can develop plans to reduce behavioral symptoms In this proposed study we will assess an online version of Tele-STELLA
STELLA-R is informed by the World Health Organization WHO guidance to include rehabilitation science in dementia care to facilitate effective management of the advancing behavioral communication physical and social changes that come with progressive neurodegenerative dementias eg Alzheimers disease frontotemporal degeneration Lewy Body dementia Grounded in self-efficacy theory and foundational research STELLA-R will train care partners to address current behavioral symptoms and prepare for future ones
The specific aims of this study are
Aim 1 Assess feasibility and acceptability of STELLA-R
Aim 2 Compare the efficacy of STELLA-R in reducing care partner reactivity to dementia-related behavioral symptoms between two groups
Care partners for those with dementia experience burden grief exhaustion and physical ailments Programs for these care partners are more available Effective interventions that reduce care partner burden and health risks are also available but various factors impede participation including distance cost behavioral symptoms of dementia stigma and social anxiety Recognizing the need to reduce barriers to access scientists have turned to internet-based interventions
The STELLA suite of research studies addresses the need for easily accessible effective interventions designed to reduce burden in care partners for those with dementia These studies examine the acceptability feasibility and efficacy of interventions modeled on Teris psychoeducational behavior change intervention We have completed two pilot studies for care partners for those with dementia using interventions with the STELLA-R precursor These studies found early efficacy and acceptability for the intervention We are currently testing a STELLA intervention which uses objective technology-based assessments OHSU IRB 19306 and another larger study which tests a STELLA intervention with a large national sample OHSU IRB 22288 NIA R01AG067546 In addition with funding from the Association for Frontotemporal Degeneration AFTD we tested a similar intervention STELLA-FTD for care partners caring for a family member with frontotemporal dementia OHSU IRB 22721
In all STELLA studies care partners work with professional guides to use the ABC analytic approach to describe a distressing behavior then identify its activators and consequences With this information care partners can develop plans to reduce behavioral symptoms In this proposed study we will assess an online version of Tele-STELLA
STELLA-R is informed by the World Health Organization WHO guidance to include rehabilitation science in dementia care to facilitate effective management of the advancing behavioral communication physical and social changes that come with progressive neurodegenerative dementias eg Alzheimers disease frontotemporal degeneration Lewy Body dementia Grounded in self-efficacy theory and foundational research STELLA-R will train care partners to address current behavioral symptoms and prepare for future ones
The specific aims of this study are
Aim 1 Assess feasibility and acceptability of STELLA-R
Aim 2 Compare the efficacy of STELLA-R in reducing care partner reactivity to dementia-related behavioral symptoms between two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None