Community Outreach for Palliative Engagement -- Parkinson Disease

NCT05222386 | Active Not Recruiting

• 1 other identifier: STUDY6775
• Study Type: interventional
• Target: 632
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease Dementia; Parkinson Disease; Parkinson's Disease and Parkinsonism; Lewy Body Parkinsonism; Dementia With Lewy Bodies; Progressive Supranuclear Palsy; Corticobasal Degeneration; Multiple System Atrophy; Vascular Parkinsonism

Outcome Measures

Primary Outcomes (2)

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

  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

  6 Months

• Zarit Caregiver Burden Interview short form (ZBI)

  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

  6 Months

Secondary Outcomes (6)

• Patient Measures Edmonton Symptom Assessment Scale

  3, 6, 9, 12 Months

• Patient Measures Hospital Anxiety and Depression Scale

  3, 6, 9, 12 Months

• Patient Measures (FACIT-SP 12)

  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

Other Outcomes (5)

• Qualitative Interviews: Patient (Validate data)

  6 Months

• Qualitative Interviews: Patient (Health Economic data)

  6 Months

• Qualitative Interviews: Carepartner (Validate data)

  6 Months

Study Arms (2)

Usual Care

OTHER

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.

Other: Parkinson Disease Standard Care

Online Community-Supported Palliative Care Intervention

OTHER

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)

Other: Online Community-Supported Palliative Care

Interventions

Parkinson Disease Standard Care OTHER

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, eight 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 eight practices will be randomized 18 months into the data collection period, and the final eight will enter the intervention 24 months into the data collection period to allow for 12 months intervention recruitment for all practices.

Usual Care

Online Community-Supported Palliative Care OTHER

Neurologist Teleconferences: Training and coaching in palliative care will be provided using the Extension for Community Healthcare Outcomes (ECHO) model augmented by a Community of Inquiry Framework to address a desire for greater peer connection, enhance self-efficacy, and to address potential weaknesses in the ECHO model for more complex interventions such as palliative care. Additional support services provided to carepartners and patients will be through the Family Caregiver Alliance's CareNav platform, including tailored educational materials, support groups and social support.

Online Community-Supported Palliative Care Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• University of Colorado, Denver: collaborator
• Stanford University: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

University of Rochester Medical Center for Health + Technology

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Parkinson Disease, Familial, Type 1; Lewy Body Disease; Supranuclear Palsy, Progressive; Corticobasal Degeneration; Multiple System Atrophy

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Neurocognitive Disorders; Mental Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Primary Dysautonomias; Autonomic Nervous System Diseases

Study Officials

• Benzi Kluger, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a pragmatic comparative effectiveness trial using a stepped-wedge design to randomize neurology practices (clusters).

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 3, 2022
• Study Start: April 26, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)