Ignite Creation Date:
2024-05-06 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05222386
Status:
RECRUITING
Last Update Posted:
2023-01-11
First Post:
2022-01-03
Brief Title:
Community Outreach for Palliative Engagement -- Parkinson Disease
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Building Online Community to Improve Patient and Caregiver Outcomes in Parkinson Disease Lewy Body Dementia and Related Disorders
Status:
RECRUITING
Status Verified Date:
2024-07
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:
COPE-PD
Brief Summary:
The purpose of this study is to learn more about the effectiveness of palliative care training for community physicians and telemedicine support services for patients and carepartners with Parkinsons disease and Lewy Body Dementia LBD or related conditions and their care partners Palliative care is a treatment approach focused on improving quality of life by relieving suffering in the areas of physical symptoms such as pain psychiatric symptoms such as depression psychosocial issues and spiritual needs Telemedicine is the use of technology that allows participants to interact with a health care provider without being physically near the provider
Detailed Description:
Investigators propose to conduct a pragmatic stepped-wedge comparative effectiveness trial comparing a novel model of providing community-based palliative care for persons living with Parkinsons disease PD Lewy Body Dementia LBD and related disorders through online communities to usual care Our intervention includes support for both community neurologists using the ECHO model of clinician support as well as family caregivers and patients Investigators hypothesize that this model of care will improve patient quality of life and caregiver burden as well as other important secondary outcomes such as patient symptom burden and clinician burnout This study will recruit neurology providers MD and APPs from 24 community neurology practices These practices will identify participants for the study who have PD LBD or a related condition and moderate to high palliative care needs Under usual care community providers will deliver their usual care and center coordinators will collect data on our outcomes every 3 months After one year of baseline data collection 6 practices will be randomized to the intervention which will include clinician training and coaching as well as access to online services for their patients Per the stepped-wedge design an additional six practices will be randomized 18 months into the data collection period six at 24 months and the final six will enter the intervention 30 months into the data collection period to allow for 12 months intervention recruitment for all practices
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