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The PACE-DLB Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04829656
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : November 23, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Florida

Brief 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.


Condition or disease
Dementia With Lewy Bodies

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identifying Factors Predicting ACcurately End-of-Life in Dementia With Lewy Bodies and Promoting Quality End-of-Life Experiences: the PACE-DLB Study
Actual Study Start Date : February 25, 2021
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Group/Cohort
Clinical Cohort
Enrolled via the 5 participating clinics at LBDA Research Centers of Excellence.
Virtual Cohort
Enrolled via the LBDA.



Primary Outcome Measures :
  1. Predictors of the end of life (death within 6 months) in the DLB population [ Time Frame: Every 6 months for up to 3 years ]
    The investigators define a variable that predicts the end of life as a variable changing substantially (e.g., quick drop of quality of life) once the patient enters last six months of life. The investigators will model and estimate the longitudinal trajectories of all potential candidate variables to identify those with significantly different trajectory patterns in the last six months of life.

  2. Identify whether change in caregiver measures can predict the end of life in the DLB [ Time Frame: Every 6 months for up to 3 years ]
    The investigators will collect caregiver measures such as quality of life, burden, depression, dementia-related grief, support, resilience, and coping for all dyads (virtual and clinical cohorts). The investigators will assess the correlation between (1) caregiver burden, depression, grief, and quality of life scores and (2) change in caregiver burden, depression, grief, and quality of life scores with the last 6 months of life of the person with DLB.

  3. Identify the impact of demographics with specific DLB symptoms on patient quality of life and caregiver experiences at the end of life of the person living with DLB [ Time Frame: Every 6 months for up to 3 years ]
    Using both the virtual and clinical cohorts, the investigators will identify which patient demographics (e.g. age, gender, sex, race/ethnicity, disease duration, level of education), caregiver demographics (e.g. age, gender, sex, race/ethnicity, relationship to patient, level of education), disease characteristics (e.g. overall symptom burden, cognition, motor function, neuropsychiatric symptoms, functional status, fluctuations, sleep-related symptoms, autonomic symptoms, medications), elements of care (rural/urban, type of healthcare provider, patient residence), and caregiver measures (self-efficacy, social support, coping skills) drive patient (QoL) and caregiver (QoL, depression, burden, grief, resilience) outcomes. These will be assessed across the disease course and specifically at the end of life (at the last clinical visit prior to death).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients at five LBDA Research Centers of Excellence clinics may enroll into the study if they meet inclusion criteria. Clinics participating in the study are located at the University of Florida, Gainesville, FL; University of Miami, Miami, FL; University of Virginia, Charlottesville, VA; University of Michigan, Ann Arbor, MI; and the Mayo Clinic, Rochester, MN.

People who have indicated interest in research opportunities through the LBDA mailing listserv will be emailed study information, including how to enroll.

Criteria

Inclusion Criteria:

  • Patient and caregiver willing to participate as a dyad (patients will need a legally authorized representative to consent on their behalf given the requirement for at least moderate dementia, but patients who resists participating in the study will not be enrolled)
  • U.S. residents (i.e., individuals accessing the LBDA from outside the U.S. will be excluded)
  • Patient with a clinical diagnosis of DLB
  • Patient with moderate severity dementia as assessed by the Quick Dementia Rating System (QDRS, with a score of >12 OR ≥2 in at least 3 domains suggestive of moderate dementia)
  • Caregiver telephone interview for cognitive status (TICS) score of >31 to ensure that the caregiver is able to reliably complete study visits
  • Patient participant expected to live at least 6 months (so that at least a baseline visit and 1 follow up visits is expected to be completed)

Exclusion Criteria:

  • Patient participant diagnosed with dementia of less than moderate severity
  • Patient with dementia resists participation
  • Non-U.S. residents
  • Patient participant with dementia not expected to live at least 6 months
  • Virtual cohort ONLY: Patient participant receives medical care from a LBDA Research Centers of Excellence clinic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04829656


Contacts
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Contact: Kaitlin Sovich, BA 352-733-3004 PACE-DLB@neurology.ufl.edu
Contact: Noheli Gamez, MHA 352-733-2419 PACE-DLB@neurology.ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Kaitlin Sovich, BA    352-733-3004    Kaitlin.Sovich@neurology.ufl.edu   
Contact: Noheli Gamez, MHA    352-733-2419    Noheli.Gamez@neurology.ufl.edu   
Principal Investigator: Melissa J. Armstrong, MD, MSc, FAAN         
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Iris R. Cohen, LCSW       irc25@med.miami.edu   
Contact: Susan Rawn, BSN, RN, CCRP       sxr3381@med.miami.edu   
Principal Investigator: James Galvin, MD, MPH         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Kelly Mattingly, LMSW    734-223-9297    mattinke@med.umich.edu   
Contact: Renee Gadwa, MBA    734-764-5137    rgadwa@med.umich.edu   
Principal Investigator: Susan Maixner, MD         
Principal Investigator: Henry Paulson, MD, PhD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Leah K. Forsberg, PhD, MS       Forsberg.Leah@mayo.edu   
Contact: Jodi Melius, RN       melius.jodi@mayo.edu   
Principal Investigator: Julie A. Fields, PhD, LP         
Principal Investigator: Angela M. Lunde, MA         
Principal Investigator: Bradley F. Boeve, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Colleen Webber, CCRC    434-243-5898    CMN6X@virginia.edu   
Principal Investigator: Carol Manning, PhD         
Sponsors and Collaborators
University of Florida
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Melissa J Armstrong, MD, MSc, FAAN University of Florida
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04829656    
Other Study ID Numbers: IRB202001438
1R01AG068128-01 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
dementia
Lewy bodies
Lewy body
aging
neurology
Additional relevant MeSH terms:
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Dementia
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases