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Clinical Trials/NCT05222386
NCT05222386
Active, not recruiting
Not Applicable

Building Online Community to Improve Patient and Caregiver Outcomes in Parkinson Disease, Lewy Body Dementia and Related Disorders

University of Rochester1 site in 1 country632 target enrollmentApril 26, 2022

Overview

Phase
Not Applicable
Intervention
Parkinson Disease Standard Care
Conditions
Parkinson Disease Dementia
Sponsor
University of Rochester
Enrollment
632
Locations
1
Primary Endpoint
Zarit Caregiver Burden Interview short form (ZBI)
Status
Active, not recruiting
Last Updated
last month

Overview

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 Parkinson's 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 Parkinson's 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.

Registry
clinicaltrials.gov
Start Date
April 26, 2022
End Date
December 31, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Benzi Kluger, MD

Professor

University of Rochester

Eligibility Criteria

Inclusion Criteria

  • PATIENT INCLUSION CRITERIA:
  • Over age 40 years and diagnosed with PD or other causes of parkinsonism, such as progressive supranuclear palsy, multiple system atrophy and Lewy Body Dementia by their community neurologist.

Exclusion Criteria

  • PATIENT EXCLUSION CRITERIA:
  • Potential patient subjects who are unable or unwilling to commit to study procedures
  • Presence of additional medical illnesses which requires palliative services (e.g. metastatic cancer)
  • Already receiving palliative care or hospice services.

Arms & Interventions

Usual Care

Community neurologists provide their usual care to enrolled participants. The clinicians may utilize other community resources to support patients and families as per their usual practice.

Intervention: Parkinson Disease Standard Care

Online Community-Supported Palliative Care Intervention

Community neurologists get training in palliative care via teleconferences (ECHO model), in addition to other support from our team. Patients and carepartners will also have access to additional support services when their providers enter the intervention (Online support groups, tailored education)

Intervention: Online Community-Supported Palliative Care

Outcomes

Primary Outcomes

Zarit Caregiver Burden Interview short form (ZBI)

Time Frame: 6 Months

Primary Outcome: Caregiver (Zarit Caregiver Burden Interview ): Investigators will use the Zarit Caregiver Burden Interview (ZBI) short form to understand the specific challenges and support preferences of persons living with Parkinson disease. Range 0-48 with higher scores = more burden

Quality of Life: Alzheimer's Disease (QOL-AD)

Time Frame: 6 Months

Primary Outcome: Patient (Quality of Life): Investigators will use the Quality of Life: Alzheimer's Disease (QOL-AD) to understand the specific challenges and support preferences of persons living with PD, their family care partner, and healthcare professionals, through the Quality of Life: Alzheimer's Disease (QOL-AD). Range 13-52, higher scores = better QOL

Secondary Outcomes

  • Carepartner Measures (FACIT-SP 12)(3, 6, 9, 12 Months)
  • Patient Measures Hospital Anxiety and Depression Scale(3, 6, 9, 12 Months)
  • Patient Measures Edmonton Symptom Assessment Scale(3, 6, 9, 12 Months)
  • Patient Measures (PG-12)(3, 6, 9, 12 Months)
  • Carepartner Measures Hospital Anxiety and Depression Scale(3, 6, 9, 12 Months)
  • Patient Measures (FACIT-SP 12)(3, 6, 9, 12 Months)

Study Sites (1)

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