Parkinson Disease Clinical Trial
— COPE-PDOfficial title:
Building Online Community to Improve Patient and Caregiver Outcomes in Parkinson Disease, Lewy Body Dementia and Related Disorders
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Medical Center for Health + Technology | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | Massachusetts General Hospital, Stanford University, University of Colorado, Denver |
United States,
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 |
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