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NCT Number: NCT05222386

Community Outreach for Palliative Engagement -- Parkinson Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Parkinson Disease Dementia Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Corticobasal Degeneration Cranial Nerve Diseases Dementia Dementia With Lewy Bodies Eye Diseases Lewy Body Disease Lewy Body Parkinsonism Mental Disorders Movement Disorders Multiple System Atrophy Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Parkinson Disease Parkinson Disease, Familial, Type 1 Parkinson's Disease and Parkinsonism Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Primary Dysautonomias Progressive Supranuclear Palsy Signs and Symptoms Supranuclear Palsy, Progressive Synucleinopathies Tauopathies Vascular Parkinsonism

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center for Health + Technology

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Patient Measures Edmonton Symptom Assessment Scale

    Time frame: 3, 6, 9, 12 Months

    Patient Measures: Investigators will use the Edmonton Symptom Assessment Scale (ESAS-PD) - Patient symptom. Edmonton Symptom Assessment Scale (ESAS-PD) - 1-10 score range per item (13 item ESAS-PD); 0-130/higher score= worse outcome

  2. Patient Measures Hospital Anxiety and Depression Scale

    Time frame: 3, 6, 9, 12 Months

    Patient Measures: Investigators will use the Hospital Anxiety and Depression Scale (HADS) - Patient Mood. Hospital Anxiety and Depression Scale (HADS)- 0-3 score range per item; higher score= worse outcome (scale broken down into depression score and anxiety score, each with 7 items)

  3. Patient Measures (FACIT-SP 12)

    Time frame: 3, 6, 9, 12 Months

    Patient Measures: Investigators will use the Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-SP 12 Item) - Patient Spiritual Wellbeing. Range 0-48 with higher scores = better spiritual wellbeing

  4. Patient Measures (PG-12)

    Time frame: 3, 6, 9, 12 Months

    Patient Measures: Investigators will use the Prolonged Grief Questionnaire (PG-12) - Patient Grief. Range 10-50 with higher scores = greater grief

  5. Carepartner Measures Hospital Anxiety and Depression Scale

    Time frame: 3, 6, 9, 12 Months

    Carepartner Measures: Investigators will use the Hospital Anxiety and Depression Scale (HADS) - Carepartner Mood. Hospital Anxiety and Depression Scale (HADS) - 0-3 score range per item; higher score= worse outcome (scale broken down into depression score and anxiety score, each with 7 items)

  6. Carepartner Measures (FACIT-SP 12)

    Time frame: 3, 6, 9, 12 Months

    Carepartner Measures: Investigators will use the Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-SP 12 Item) - Carepartner Spiritual Wellbeing

Other outcomes

  1. Qualitative Interviews: Patient (Validate data)

    Time frame: 6 Months

    Investigators will validate and build upon prior qualitative data from our group regarding needs (domains) to ensure adequate coverage by our intervention.

  2. Qualitative Interviews: Patient (Health Economic data)

    Time frame: 6 Months

    Investigators will collect health economic data and utilize qualitative interviews and mixed methods to gain a deeper understanding of the economic impact of the intervention, and other potential benefits of the intervention as well as opportunities to optimize it around patient and clinician preferences.

  3. Qualitative Interviews: Carepartner (Validate data)

    Time frame: 6 Months

    Investigators will validate and build upon prior qualitative data from our group regarding needs (domains) to ensure adequate coverage by our intervention.

    In addition, investigators will collect health economic data and utilize qualitative interviews and mixed methods to gain a deeper understanding of the economic impact of the intervention, and other potential benefits of the intervention as well as opportunities to optimize it around carepartner and clinician preferences..

  4. Qualitative Interviews: Carepartner (Health Economic data)

    Time frame: 6 Months

    Investigators will collect health economic data and utilize qualitative interviews and mixed methods to gain a deeper understanding of the economic impact of the intervention, and other potential benefits of the intervention as well as opportunities to optimize it around carepartner and clinician preferences.

  5. Qualitative Interviews: Clinician

    Time frame: 6 Months

    Clinician knowledge and attitudes: Investigators will be tested on clinician's palliative care knowledge, assess attitudes and burnout pre and post intervention.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Massachusetts General Hospital
  • Stanford University
  • University of Colorado, Denver

Registry information

Official study title

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

Acronym: COPE-PD

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2022
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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