Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05222386
Other study ID # STUDY6775
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 26, 2022
Est. completion date August 31, 2026

Study information

Verified date January 2023
Source University of Rochester
Contact Benzi Kluger, MD
Phone 585-275-2529
Email Benzi_Kluger@URMC.Rochester.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 710
Est. completion date August 31, 2026
Est. primary completion date February 28, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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.

Study Design


Intervention

Other:
Parkinson Disease Standard Care
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
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.

Locations

Country Name City State
United States University of Rochester Medical Center for Health + Technology Rochester New York

Sponsors (4)

Lead Sponsor Collaborator
University of Rochester Massachusetts General Hospital, Stanford University, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Qualitative Interviews: Patient (Validate data) Investigators will validate and build upon prior qualitative data from our group regarding needs (domains) to ensure adequate coverage by our intervention. 6 Months
Other Qualitative Interviews: Patient (Health Economic data) 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. 6 Months
Other Qualitative Interviews: Carepartner (Validate data) 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..
6 Months
Other Qualitative Interviews: Carepartner (Health Economic data) 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. 6 Months
Other Qualitative Interviews: Clinician Clinician knowledge and attitudes: Investigators will be tested on clinician's palliative care knowledge, assess attitudes and burnout pre and post intervention. 6 Months
Primary 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
Primary 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 Patient Measures Edmonton Symptom Assessment Scale 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 3, 6, 9, 12 Months
Secondary Patient Measures Hospital Anxiety and Depression Scale 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, 6, 9, 12 Months
Secondary Patient Measures (FACIT-SP 12) 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 3, 6, 9, 12 Months
Secondary Patient Measures (PG-12) Patient Measures: Investigators will use the Prolonged Grief Questionnaire (PG-12) - Patient Grief. Range 10-50 with higher scores = greater grief 3, 6, 9, 12 Months
Secondary Carepartner Measures Hospital Anxiety and Depression Scale 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) 3, 6, 9, 12 Months
Secondary Carepartner Measures (FACIT-SP 12) Carepartner Measures: Investigators will use the Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-SP 12 Item) - Carepartner Spiritual Wellbeing 3, 6, 9, 12 Months
See also
  Status Clinical Trial Phase
Completed NCT05415774 - Combined Deep Brain Stimulation in Parkinson's Disease N/A
Recruiting NCT04691661 - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease Phase 2
Active, not recruiting NCT05754086 - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed NCT04045925 - Feasibility Study of the Taïso Practice in Parkinson's Disease N/A
Recruiting NCT04194762 - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation N/A
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05830253 - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Recruiting NCT06139965 - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed NCT04580849 - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease N/A
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Completed NCT03980418 - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam N/A
Completed NCT04942392 - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic N/A
Terminated NCT03446833 - LFP Beta aDBS Feasibility Study N/A
Completed NCT03497884 - Individualized Precise Localization of rTMS on Primary Motor Area N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT04997642 - Parkinson's Disease and Movement Disorders Clinical Database
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT03618901 - Rock Steady Boxing vs. Sensory Attention Focused Exercise N/A