Does Outpatient Palliative Care Improve Patient-centered Outcomes in Parkinson's Disease?
1 other identifier
interventional
210
2 countries
3
Brief Summary
The purpose of this study is to improve outcomes for persons living with Parkinson's Disease (PD) and their family caregivers. The investigators hypothesize that outpatient interdisciplinary palliative care will improve patient-centered outcomes for PD patients at high-risk for poor outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2015
CompletedFirst Posted
Study publicly available on registry
August 27, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedResults Posted
Study results publicly available
January 31, 2020
CompletedJanuary 31, 2020
January 1, 2019
3 years
August 20, 2015
January 10, 2019
January 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in the Subjects Quality of Life (QOL)
The QOL-AD (Quality of Life in Alzheimer's Disease) survey will be used to measure the differences in the quality of life between groups.Higher numbers indicate better outcomes. The scale ranges from 4 to 52.
0 to 6 months
Changes in Caregiver Distress
The Zarit Caregiver Burden Interview Form (ZBI) will be used to measure differences in Caregiver Distress between groups. Higher scores indicate worse outcomes. Scale ranges from 0 to 48.
0 to 6 months
Secondary Outcomes (4)
Changes in Patient Anxiety
0 to 6 months
Changes in Patient Depression
0 to 6 months
Changes in Caregiver Anxiety
0 to 6 months
Changes in Caregiver Depression
0 to 6 months
Study Arms (2)
Standard of Care
OTHERUsual care as in including both a Primary Care Physician (PCP) and neurologist.
Interdisciplinary outpatient palliative care
ACTIVE COMPARATORUsual care augmented by an outpatient interdisciplinary palliative care team.
Interventions
Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease.
Eligibility Criteria
You may qualify if:
- Fluent in English
- UK Brain Bank criteria for diagnosis of probable PD or Multiple Systems Atrophy (MSA) or Corticobasal Degeneration (CBD) or Progressive Supranuclear Palsy (PSP) or Lewy Body Dementia (LBD)
- At high risk for poor outcomes as identified by the Palliative Care Needs Assessment Tool (PC-NAT)
You may not qualify if:
- Immediate and urgent palliative care needs
- Unable or unwilling to commit to study procedures including;
- randomization,
- study visits or
- the addition of a neurologist to their care team
- Presence of additional chronic medical illnesses which may require palliative services
- Already receiving palliative care and/or hospice services.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- University of California, San Franciscocollaborator
- University of Albertacollaborator
Study Sites (3)
University of California, San Francisco
San Francisco, California, 94143, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
University of Alberta Canada
Edmonton, Alberta, T6G 2E1, Canada
Related Publications (3)
Macchi ZA, Miyasaki J, Katz M, Galifianakis N, Sillau S, Kluger BM. Prevalence and Cumulative Incidence of Caregiver-Reported Aggression in Advanced Parkinson Disease and Related Disorders. Neurol Clin Pract. 2021 Dec;11(6):e826-e833. doi: 10.1212/CPJ.0000000000001110.
PMID: 34992965DERIVEDKoljack CE, Miyasaki J, Prizer LP, Katz M, Galifianakis N, Sillau SH, Kluger BM. Predictors of Spiritual Well-Being in Family Caregivers for Individuals with Parkinson's Disease. J Palliat Med. 2022 Apr;25(4):606-613. doi: 10.1089/jpm.2020.0797. Epub 2021 Nov 24.
PMID: 34818097DERIVEDKluger BM, Miyasaki J, Katz M, Galifianakis N, Hall K, Pantilat S, Khan R, Friedman C, Cernik W, Goto Y, Long J, Fairclough D, Sillau S, Kutner JS. Comparison of Integrated Outpatient Palliative Care With Standard Care in Patients With Parkinson Disease and Related Disorders: A Randomized Clinical Trial. JAMA Neurol. 2020 May 1;77(5):551-560. doi: 10.1001/jamaneurol.2019.4992.
PMID: 32040141DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Benzi Kluger, MD, MS, Principal Investigator
- Organization
- University of Colorado
Study Officials
- PRINCIPAL INVESTIGATOR
Benzi Kluger
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2015
First Posted
August 27, 2015
Study Start
October 1, 2015
Primary Completion
September 20, 2018
Study Completion
September 30, 2019
Last Updated
January 31, 2020
Results First Posted
January 31, 2020
Record last verified: 2019-01