Protocol for an observational cohort study identifying factors predicting accurately end of life in dementia with Lewy bodies and promoting quality end-of-life experiences: the PACE-DLB study

Abstract

Introduction: Dementia with Lewy bodies (DLB) is one of the most common degenerative dementias. Despite the fact that most individuals with DLB die from complications of the disease, little is known regarding what factors predict impending end of life or are associated with a quality end of life.

Methods and analysis: This is a multisite longitudinal cohort study. Participants are being recruited from five academic centres providing subspecialty DLB care and volunteers through the Lewy Body Dementia Association (not receiving specialty care). Dyads must be US residents, include individuals with a clinical diagnosis of DLB and at least moderate-to-severe dementia and include the primary caregiver, who must pass a brief cognitive screen. The first dyad was enrolled 25 February 2021; recruitment is ongoing. Dyads will attend study visits every 6 months through the end of life or 3 years. Study visits will occur in-person or virtually. Measures include demographics, DLB characteristics, caregiver considerations, quality of life and satisfaction with end-of-life experiences. For dyads where the individual with DLB dies, the caregiver will complete a final study visit 3 months after the death to assess grief, recovery and quality of the end-of-life experience. Terminal trend models will be employed to identify significant predictors of approaching end of life (death in the next 6 months). Similar models will assess caregiver factors (eg, grief, satisfaction with end-of-life experience) after the death of the individual with DLB. A qualitative descriptive analysis approach will evaluate interview transcripts regarding end-of-life experiences.

Ethics and dissemination: This study was approved by the University of Florida institutional review board (IRB202001438) and is listed on clinicaltrials.gov (NCT04829656). Data sharing follows National Institutes of Health policies. Study results will be disseminated via traditional scientific strategies (conferences, publications) and through collaborating with the Lewy Body Dementia Association, National Institute on Aging and other partnerships.

Keywords: adult palliative care; dementia; neurology.

Conflict of interest statement

Competing interests: MJA receives research support from the NIA (P30AG047266, R01AG068128) and the Florida Department of Health (grant 20A08). She is the local PI of a Lewy Body Dementia Association Research Center of Excellence. She serves on the Scientific Advisory Board of the Lewy Body Dementia Association. HLP receives funding from the NIA (1P30AG053760) and is the local PI of a Lewy Body Dementia Association Research Center of Excellence. SMM has no competing interests. JAF receives research support from the NIA (U01NS100620, R01AG068128, R43AG65088). AML receives research support from the NIA (P30AG62677, R43AG65088). She is a Program Coordinator for the local a Lewy Body Dementia Association Coordinating Center Research Center of Excellence. BFB has served as an investigator for clinical trials sponsored by Biogen, Alector and EIP Pharma. He serves on the Scientific Advisory Board of the Lewy Body Dementia Association, Association for Frontotemporal Degeneration and Tau Consortium. He is the site PI of a Lewy Body Dementia Association Research Center of Excellence program, as well as coordinating center PI of the program. He receives research support from the NIH, the Mayo Clinic Dorothy and Harry T. Mangurian Jr. Lewy Body Dementia Programme, and the Little Family Foundation. CM receives research support from ACL/DHHS (90ALGG0014-01-00), NIA/NIH (2SB1AG037357-04A1, R01-AG-054435), HRSA (U1QHP287440400) and DoD (AZ190036). She is the local PI of a Lewy Body Dementia Association Research Center of Excellence. JEG is the creator of the QDRS and the LBCRS. He is supported by grants from the National Institutes of Health (R01 AG069765, R01 AG057681, R01 NS101483, P30 AG059295, U54 AG06354, R01 AG056531, U01 NS100610, R01 AG056610, R01 AG054425, R01 AG068128) and the Leo and Anne Albert Charitable Trust. He is the local PI of the Lewy Body Dementia Association Research Center of Excellence at the University of Miami and serves on the Scientific Advisory Board of the Lewy Body Dementia Association. AT is an employee of the Lewy Body Dementia Association. ZL has no competing interests.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Identifying Factors Predicting ACcurately End-of-Life in Dementia withLewy Bodies and Promoting Quality End-of-Life Experiences (PACE-DLB) study design: the PACE-DLB study will recruit 75 dyads (individuals with DLB and their primary informal caregiver) from subspecialty clinics and 75 dyads not receiving subspecialty care. After meeting inclusion criteria, dyads will have a baseline study visit and then return for follow-up study visits every 6 months for 3 years or until the death of the individual with DLB. Caregivers of individuals with DLB who die during the study will complete a final study visit 3 months after the death of the person with DLB. DLB, dementia with Lewy bodies.