Palliative Care for Parkinson's Disease

(COPE-PD Trial)

Overseen By Christina Seger

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Rochester

Disqualifiers: Metastatic cancer, Receiving palliative care, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Online Community-Supported Palliative Care, Community-Based Palliative Care, Telehealth Palliative Care, Online Palliative Support for Parkinson's Disease?

Research shows that telehealth can improve access to palliative care for people with Parkinson's disease, especially those in under-resourced areas or who are homebound. Palliative care is endorsed for its ability to reduce suffering and improve quality of life for patients and their families. ^{1 2 3 4 5}

Is telehealth palliative care safe for humans?

The research on telehealth palliative care, which includes methods like video conferencing and online platforms, suggests it is generally safe and well-received by patients, caregivers, and providers. It has been used effectively for monitoring symptoms and managing care, with positive experiences reported in most studies. ^{6 7 8 9 10}

How does palliative care differ from other treatments for Parkinson's disease?

Palliative care for Parkinson's disease is unique because it focuses on improving quality of life by addressing physical, psychological, social, and spiritual issues from the time of diagnosis, rather than just treating symptoms. It can be delivered through telehealth, increasing access for those in under-resourced areas or who are homebound, and involves a team approach that includes specialists to handle complex issues. ^{2 3 5 11 12}

Research Team

Benzi Kluger, MD

Principal Investigator

University of Rochester

Eligibility Criteria

This trial is for people over 40 with Parkinson's disease or related conditions like progressive supranuclear palsy, multiple system atrophy, and Lewy Body Dementia. It's not for those who can't commit to the study, need palliative care for other illnesses like advanced cancer, or are already receiving palliative or hospice care.

Inclusion Criteria

I am over 40 and diagnosed with Parkinson's or a similar condition.

Exclusion Criteria

I have a serious illness that needs comfort care, like metastatic cancer.

I am currently receiving care to ease symptoms or hospice services.

I am willing and able to follow the study's procedures.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Baseline data collection for usual care practices before intervention begins

12 months

Data collected every 3 months

Intervention

Community neurologists receive palliative care training and patients access online support services

12 months

Ongoing telemedicine support

Follow-up

Participants are monitored for quality of life and caregiver burden

6 months

Data collected every 3 months

Treatment Details

Interventions

• Online Community-Supported Palliative Care (Behavioural Intervention)

Trial Overview The study tests how effective it is when community doctors get training in palliative care and patients along with their caregivers receive support through telemedicine. Palliative care aims to improve life quality by easing physical pain, depression, social issues, and spiritual needs using technology.

Participant Groups

Group I: Usual Care Experimental Treatment 1 Intervention

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.

Group II: Online Community-Supported Palliative Care Intervention Experimental Treatment 1 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)

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Findings from Research

Palliative care is endorsed as a crucial approach for managing Parkinson's disease, focusing on reducing suffering through comprehensive support that includes spiritual, psychosocial, and medical assistance.

The council emphasizes that palliative care should begin at the time of diagnosis and continue throughout the patient's journey, providing essential emotional support and resources for both patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care for Parkinson's disease: suggestions from a council of patient and carepartners. Hall, K., Sumrall, M., Thelen, G., et al.[2020]

This study aims to explore the experiences of patients with Parkinson's disease, their family caregivers, and palliative care professionals to better understand the specific palliative care needs for this population, as current guidelines recommend palliative care to enhance quality of life.

The research will utilize a mixed methods approach over 8-12 months, including interviews and questionnaires, to gather comprehensive data that could inform future palliative care protocols and interventions for Parkinson's disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care for patients with Parkinson's disease: study protocol for a mixed methods study. Lennaerts, H., Groot, M., Steppe, M., et al.[2022]

Palliative care can significantly improve the quality of life for patients with Parkinson's disease (PD) not just in advanced stages, but also early in the disease course, highlighting the need for timely intervention.

Primary palliative care, delivered by neurologists or primary care providers, is well-suited to meet the palliative needs of most PD patients, but there is a need for better methods to identify these needs and enhance education for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care and Parkinson's disease: outpatient needs and models of care over the disease trajectory. Tarolli, CG., Holloway, RG.[2020]

This study will evaluate a nurse-led palliative care intervention for people with Parkinson's disease across seven European countries, focusing on Advance Care Planning (ACP) to improve patient quality of life and care coordination.

The primary goal is to measure the percentage of participants with documented ACP decisions after 6 months, while secondary outcomes will assess quality of life, symptom burden, and cost-effectiveness, providing insights into the feasibility and impact of palliative care in diverse settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance Care Planning and Care Coordination for People With Parkinson's Disease and Their Family Caregivers-Study Protocol for a Multicentre, Randomized Controlled Trial. Meinders, MJ., Gentile, G., Schrag, AE., et al.[2021]

Telehealth significantly improves access to palliative care for individuals with Parkinson's disease and related disorders, especially for those who are homebound or live in under-resourced areas.

By enhancing access to specialized neurological care through telehealth, there is potential for improved quality of life for patients and their caregivers, highlighting the importance of research and policy efforts in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth increases access to palliative care for people with Parkinson's disease and related disorders. Katz, M.[2020]

A systematic review of nine studies on telehealth interventions in palliative care found that while caregiver satisfaction was generally positive, there were no significant improvements in caregiver quality of life after the interventions.

Some studies reported reductions in caregiver anxiety and burden, indicating potential benefits, but overall outcomes were not substantial, highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Telehealth in Palliative Care: Caregiver Outcomes. Zheng, Y., Head, BA., Schapmire, TJ.[2018]

Telehealth in home-based palliative care offers significant advantages, such as providing a support system that allows patients to stay at home and fostering interpersonal relationships with healthcare professionals through visual communication.

However, challenges exist, including technological barriers and difficulties in reporting complex symptoms, which can make telehealth feel intrusive for some patients; future research should involve users in the design process to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advantages and Challenges of Using Telehealth for Home-Based Palliative Care: Systematic Mixed Studies Review. Steindal, SA., Nes, AAG., Godskesen, TE., et al.[2023]

This study will compare two palliative care models—nurse-led telephonic case management and specialty outpatient care—among 1350 older adults with serious illnesses, aiming to determine which method better improves patient quality of life and reduces healthcare utilization.

The trial will also assess impacts on caregiver strain and quality of life, providing a comprehensive view of how different palliative care approaches affect both patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness. Grudzen, CR., Shim, DJ., Schmucker, AM., et al.[2020]

Telehealth self-reporting allows patients with advanced conditions, like lung cancer, to communicate their symptoms and functional status in real time, which can lead to timely management of their care.

The use of videoconferencing for consultations was highly valued by the patient, as it improved communication with healthcare providers and removed the need for travel, highlighting the feasibility and acceptability of telehealth in community palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring via Self-Report and Video Review in Community Palliative Care: A Case Report. Morgan, DD., Swetenham, K., To, THM., et al.[2020]

Telehealth applications have been found effective in delivering palliative care to patients in remote and rural communities, improving symptom management and quality of life based on a review of 18 studies involving over 3,300 patients.

Despite the positive outcomes, the studies revealed significant biases and limitations, indicating a need for more rigorous research to establish best practices for virtual palliative care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging Telehealth for Delivery of Palliative Care to Remote Communities: A Rapid Review. Gordon, B., Mason, B., Smith, SLH.[2022]

Palliative care is crucial for patients with Parkinson's disease and related disorders, addressing not just physical symptoms but also psychological, social, and spiritual needs from the time of diagnosis.

Specialist palliative care enhances overall patient care by managing complex issues and improving the quality of life for both patients and their families, emphasizing collaboration among healthcare teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specialist palliative care for Parkinson's disease. Oliver, D., Veronese, S.[2020]

A systematic review of 19 studies on palliative care for advanced Parkinson's disease identified 10 clinical tools for assessing palliative needs and various interventions aimed at improving quality of life.

The review highlighted both pharmacological and non-pharmacological interventions that effectively manage motor and non-motor symptoms, demonstrating a comprehensive approach to enhancing patient care in advanced Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Palliative care for people with advanced Parkinson's disease. A systematic review]. Sánchez-Cárdenas, MA., Sánchez-Rua, M., Sequea-Torregrosa, L., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Palliative care for Parkinson's disease: suggestions from a council of patient and carepartners. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Palliative care for patients with Parkinson's disease: study protocol for a mixed methods study. [2022]

3. China pubmed.ncbi.nlm.nih.gov

Palliative care and Parkinson's disease: outpatient needs and models of care over the disease trajectory. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Advance Care Planning and Care Coordination for People With Parkinson's Disease and Their Family Caregivers-Study Protocol for a Multicentre, Randomized Controlled Trial. [2021]

5. China pubmed.ncbi.nlm.nih.gov

Telehealth increases access to palliative care for people with Parkinson's disease and related disorders. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Telehealth in Palliative Care: Caregiver Outcomes. [2018]

7. Canada pubmed.ncbi.nlm.nih.gov

Advantages and Challenges of Using Telehealth for Home-Based Palliative Care: Systematic Mixed Studies Review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Telemonitoring via Self-Report and Video Review in Community Palliative Care: A Case Report. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Leveraging Telehealth for Delivery of Palliative Care to Remote Communities: A Rapid Review. [2022]

11. China pubmed.ncbi.nlm.nih.gov

Specialist palliative care for Parkinson's disease. [2020]

12. Spain pubmed.ncbi.nlm.nih.gov

[Palliative care for people with advanced Parkinson's disease. A systematic review]. [2023]