Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04829656 |
| Other study ID # |
IRB202001438 |
| Secondary ID |
1R01AG068128-01 |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 25, 2021 |
| Est. completion date |
May 2025 |
Study information
| Verified date |
January 2024 |
| Source |
University of Florida |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The PACE-DLB Study is for people with at least moderate dementia with Lewy bodies (DLB) and
their primary caregiver. The study's goals are to learn more about the experiences of people
with DLB and their caregivers as DLB progresses, and what happens as the end of life of the
person with DLB approaches. Participants are enrolled through one of five Lewy Body Dementia
Association (LBDA) Research Center of Excellence clinics, or directly via the LBDA.
People with DLB will enroll into the study along with their primary informal caregiver, such
as the family member or friend who is involved in most of their care and attends the majority
of their medical appointments. A legally authorized representative (LAR) for the person with
DLB will consent to participate in the study on the person's behalf. If the person with DLB
resists taking part in the study, the pair will not be enrolled.
The study consists of questionnaires about the progression of the person's dementia and the
experiences of the caregiver. The person with DLB will complete one questionnaire themselves
if they are able to. If the pair is enrolled at a LBDA Research Center of Excellence clinical
site, and completes study visits in-person, a brief physical exam of the person with DLB will
be completed by a clinician.
Study participation will last for three years, or until the person with DLB dies. Study
visits take place every six months, either virtually or in person at a clinical study site.
If the person with DLB dies during the study, the caregiver will complete one final virtual
study visit three months afterward.
Specific Aims of the PACE-DLB Study:
1. To determine predictors of the end of life (death within 6 months) in the DLB
population.
Hypotheses: Predictors of death within 6 months for individuals with DLB will include
symptoms (e.g. worsening hallucinations, fluctuations) not captured in existing dementia
end-of-life prediction tools.
2. To identify whether change in caregiver measures can predict the end of life in the DLB.
Hypotheses: The investigators hypothesize that there will be worsening caregiver burden,
depression, grief, and quality of life preceding the last 6 months of life, controlling
for variables such as resilience, support, and living situation.
3. To identify the impact of demographics, health care factors, and specific DLB symptoms
on patient quality of life and caregiver experiences at the end of life of the person
living with DLB.
Hypotheses: Location (rural, urban, suburban), provider experience (e.g. specialist vs not),
patient residence (e.g. home, skilled nursing), degree of behavioral symptoms, caregiver type
(spouse vs child vs other), and caregiver characteristics (self-efficacy, perceived social
support, resilience, and coping) will affect patient and informal caregiver experiences at
the patient's end of life, including patient and caregiver quality of life and caregiver
well-being, depression, burden, grief, and satisfaction with end-of-life care.
Description:
Dementia with Lewy bodies (DLB) is part of Lewy body dementia, the 2nd-most-common
degenerative dementia in the U.S. It is also one of the Alzheimer's disease-related dementias
(ADRDs). Evidence-based models of end-of-life care for ADRDs are insufficient; families face
difficult medical decisions with little information for guidance. This is particularly
relevant for DLB, where >70% of individuals die of the dementia itself or failure to thrive.
Caregivers describe lack of knowledge of what to expect at the end of life as an important
driver of negative end-of-life experiences. The proposed study addresses this unmet need. It
also addresses the National Institute on Aging's priority to improve quality of care and
quality of life for persons with ADRDs at the end of life and their caregivers.
Based on published clinical series, over half of enrolled individuals with DLB are expected
to die over the course of the study. To achieve diverse recruitment, the study includes an
in-person cohort where dyads are recruited from Lewy Body Dementia Association Research
Centers of Excellence and a novel virtual cohort where dyads are recruited through the Lewy
Body Dementia Association and study visits are conducted by telephone. Having a virtual
cohort will capture the experiences of individuals with DLB and caregivers not receiving care
at specialty centers.
Because the majority of study measures are caregiver-reported, the in-person and virtual
groups have identical study measures, except for the Unified Parkinson Disease Rating Scale,
completed only in person. Collected measures will include demographics, DLB characteristics
(e.g. cognitive, motor, behavioral, sleep, and autonomic symptoms), health care providers and
settings, caregiver considerations (e.g. resilience, support, grief, burden), quality of life
(for the patient and caregiver), and satisfaction with end of life experiences.
The caregiver will complete a final study visit 3 months after the death of the person with
DLB to assess grief, recovery, and quality of the end of life experience. By following dyads
through the end of life and death of the person with DLB and the initial bereavement period
for the caregiver, the study will identify DLB-specific predictors of the last 6 months of
life, changes in caregiver measures that identify the last 6 months of life, and factors
which influence quality end of life experiences. These results will inform the content and
timing of end-of-life counseling in DLB, help establish quality metrics for end of life care,
and identify areas where interventions could potentially improve end of life experiences for
individuals with DLB and their caregivers.
