Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04335110 |
| Other study ID # |
STUDY00019306 |
| Secondary ID |
2P30AG024978-16 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 24, 2021 |
| Est. completion date |
June 15, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
Oregon Health and Science University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Introduction and Specific Aims:
Family members who care for those with Alzheimer's disease and related dementias (ADRD) may
find a sense of meaning, opportunity and power in their evolving role, but they may also find
the experience burdensome, leading to depression, anxiety and grief. Caregiving can also have
negative effects on health, including impairments in cardiovascular health, immune function,
restorative sleep and cognitive function. As care demands build over the long duration of
disease, the quality of life for the care dyad (the person with dementia, (PwD) and their
care partner (CP)) is affected and the risk of placement for the PwD increases. Interventions
that reduce the CP affective and physical burden, and delay PwD placement are available to
support the 16 million ADRD CPs in the United States, but access to them is limited by a
number of factors, including geographic distance, financial resources and stigma.
Internet-based videoconferencing technology (also known as "telehealth") is making education
and support interventions more accessible for families living with ADRD. These interventions
have had small to moderate effects on reducing CP burden and depression and good consumer
acceptance. However, despite evidence that CPs prefer individualized interventions with
real-time counselors, most telehealth interventions are group-based, automated and not
tailored to stages of disease. Also, while the telehealth interventions target important
aspects of the CP affective experience (burden, depression), few address sleep issues or the
cognitive dysfunction that can result from caregiving. Further, limited information is
available about the mechanisms of action of these technology-based interventions.
To address the need for personalized, real-time educational interventions for families caring
for those in moderate to late-stage dementia, we designed Tele-STELLA (Support via
TEchnology: Living and Learning with ADRD). Tele-STELLA uses videoconferencing to connect
nurse consultants with CPs, in both one-to-one and then small group sessions. STELLA uses
cognitive behavioral techniques to guide CPs in strategies to reduce the emotional, cognitive
and physical effects of upsetting behavioral symptoms of dementia. Pilot testing of STELLA
prototypes found that the intervention reduced burden. Focus groups revealed that CPs liked
the one-to-one telehealth format, but did not like the abrupt cessation after completing the
8 weekly sessions. They asked for opportunities to connect with other caregivers to sustain
support.
There are few known telehealth interventions that use combined one-to-one and group sessions.
This novel study, co-developed with CPs, will provide feasibility and efficacy data and help
understand the mechanisms of change for this intervention. Further, this study will be one of
the first to use objective data from the ORCASTRAIT LL to learn about Tele-STELLA's
mechanisms of behavior change.
Phase 1 assesses the STELLA intervention, Phase 2 assesses costs and the effect of the
intervention on costs.
Phase 1
1. Using quantitative and qualitative approaches, assess feasibility and participant
acceptability of (a) STELLA, and (b) the assessment methods (subjective measures and
unobtrusive objective monitoring).
2. Using quantitative strategies, assess the preliminary effect of STELLA on (a) the
affective impact of caregiving, Care Partner cognitive function and person with dementia
quality of life, and on (b) Care Partner and person with dementia objective digital
behavioral biomarkers (activity, sleep and time together).
3. Test the feasibility of employing digital behavioral biomarker data, combined with
qualitative Care Partner feedback, to assess mechanisms of behavior change before,
during and after the STELLA intervention.
Phase 2
1. Quantify the costs of delivering the STELLA intervention.
2. Quantify the cost efficacy of STELLA in relation to BPSD frequency and CP reactivity and
assess the relationship between costs, BPSD, and care partner burden.
H1: There is a relationship between BPSD and cost: More BPSD behaviors and more CP reactivity
to the BPSD are associated with higher out-of-pocket and implicit costs for families living
with dementia.
H2: There is a relationship between out-of-pocket and implicit costs and objective measures
of burden identified in the ORCASTRAIT Living Lab continuous home assessment. Higher
objective burden will correlate with higher implicit and out-of-pocket costs.
STELLA is an ancillary study embedded in the Oregon Roybal Center for CAre Support
Translational Research Advantaged by Integrating Technology (ORCASTRAIT) parent study
(IRB#20236).
THEORETICAL FRAMEWORK AND MECHANISMS OF ACTION: Tele-STELLA is framed by Vitaliano et al's
model which hypothesizes that CP stress exposure catalyzes a cascade of concerns, including
psychological, physiological and cognitive strain. The original model places the caregiver at
the top of the model as the recipient of a stressor. However, the PwD also experiences
stressors, such as CP disengagement. Thus, we include the PwD, who is also vulnerable to the
stress of caregiving, at the top of the model. By addressing behavioral symptoms in both the
CP and the PwD, it is hypothesized that Tele-STELLA will be feasible and acceptable to
families, will reduce the negative effects of ADRD on the family, and that objective feedback
(provided by digital biomarker data) will inform the efficacy of the intervention and the
mechanisms of behavior change.
Significance Providing care for a family member with Alzheimer's disease or a related
dementia (ADRD) is both rewarding and risky. CPs exposed to chronic stress, often over years,
are susceptible to physical and psychological ailments. In addition, the caregiving
experience increases the risk of cognitive impairment in CPs, with spousal CPs being
particularly vulnerable, thus potentially perpetuating a cycle when yet another family member
has to care for the former CP. Effective interventions that reduce caregiver burden and
reduce health risks are available, but various factors impede CP 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.
Recent research indicates that multi-component technology-facilitated interventions which
allow CP engagement with health professionals are effective and favored by caregivers.
However, only a minority of studies allow for health professional engagement, and of these,
only a handful provide real-time interaction. Hopwood et al concluded that, despite the fact
that family needs vary across ADRD stages, the interventions reviewed were not targeted to a
specific stage of ADRD.
We have completed two pilot studies using Internet-based CP interventions. These studies
tested the feasibility and consumer acceptability of the evidence-based, Staff Training in
Assisted-living Residences - Caregivers (STAR-C) intervention, the precursor to Tele-STELLA,
when delivered via telehealth. Qualitative data revealed the telehealth intervention was
acceptable to CPs and preferred over a potential in-home ("live") intervention. We found that
burden was reduced, but depression was not. This may be because the interaction with the
nurse consultant formally ended with the concluding Session 8, leaving CPs with a sense of
isolation, as this CP commented: "I went through withdrawals… I wanted to call her (the nurse
consultant)-who can I turn to?" The prototype interventions did not include meaningful
opportunities for CPs to interact with each other post-intervention. CPs felt their support
vanished and did not like "the fact that it was over". Participants advised that future
interventions should include both one-to-one sessions and one-to-multiple sessions.
Based on the qualitative and quantitative data from the pilot work Tele-STELLA was designed
to address the specific needs of families living with dementia. Tele-STELLA is a
multi-component, tailored intervention that begins with one-to-one sessions with each CP and
nurse consultant, then links CPs to each other in a meaningful way to sustain support post
intervention. Tele-STELLA is designed for families living in the later stages of dementia,
where behavioral symptoms are more prominent and distressing for all.
Innovation This pilot is innovative in several ways. First, we are testing a new intervention
format (blended one-to-one and one-to three) using an online environment (Internet-based
videoconferencing technology). Second, we are examining novel strategies for assessing the
effect of the intervention and mechanisms of action using unobtrusive, objective monitoring
of digital behavioral biomarkers (sleep, time together, activity). Finally, we are collecting
data (saved video and audio files) that can be used for future objective assessment of dyad
well-being, such as assessing conversational dynamics through linguistic analysis of session
interactions or employing facial recognition techniques to assess CP emotions. Taken
together, this pilot will set the stage to advance caregiving science beyond traditional,
earthbound approaches.
