Clinical trial NCT04335110: Assessing Acceptability, Cost, and Efficacy of STELLA-Support Via Technology
Official title: Assessing Acceptability, Cost, and Efficacy of STELLA-Support Via Technology: Living and Learning With Advancing AD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Caregiver Burnout
Family Members
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-04-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

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)

Primary outcomes:
measure: Revised Memory and Behavior Problems Checklist
timeFrame: The RMBPC is assessed 1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)
measure: Center for Epidemiological Studies Depression Scale
timeFrame: 1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)
Secondary outcomes:
measure: Desire to Institutionalize (DTI) Scale
timeFrame: Measured at study entry only
measure: Marwit Meuser Caregiver Grief Index
timeFrame: 1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)
measure: Feasibility and Participant Acceptability
timeFrame: Measured only once by caregivers 1 week after 8-week intervention
measure: Quality of Life in Alzheimer's Disease (QOL-AD) Scale
timeFrame: 1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)
measure: Sleep Duration
timeFrame: 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)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Walter Dawson, PhD
role: PRINCIPAL_INVESTIGATOR
References: