Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04829656
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-10
First Post:
2021-03-22
Brief Title:
The PACE-DLB Study
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The PACE-DLB Study is for people with at least moderate dementia with Lewy bodies DLB and their primary caregiver The studys 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 persons 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 persons 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 eg 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 eg specialist vs not patient residence eg 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 patients end of life including patient and caregiver quality of life and caregiver well-being depression burden grief and satisfaction with end-of-life care
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 persons 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 persons 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 eg 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 eg specialist vs not patient residence eg 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 patients end of life including patient and caregiver quality of life and caregiver well-being depression burden grief and satisfaction with end-of-life care
Detailed Description:
Dementia with Lewy bodies DLB is part of Lewy body dementia the 2nd-most-common degenerative dementia in the US It is also one of the Alzheimers 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 Agings 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 eg cognitive motor behavioral sleep and autonomic symptoms health care providers and settings caregiver considerations eg 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
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 eg cognitive motor behavioral sleep and autonomic symptoms health care providers and settings caregiver considerations eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AG068128-01 | NIH | None | httpsreporternihgovquickSearch1R01AG068128-01 |