Parkinson DiseaseMTMDNCT03076671
More Than a Movement Disorder: Applying Palliative Care to Parkinson's Disease
A study testing Palliative Care in people with Parkinson Disease and Parkinsonism, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
This is a two-center (University of Colorado, University of California San Francisco) community-based comparative effectiveness study of outpatient palliative care for Parkinson's disease (PD) and related disorders (progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), multiple systems atrophy (MSA)… Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Parkinson Disease, Parkinsonism, Lewy Body Disease
- What is being tested?
- Palliative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 783 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be fluent English Speakers,
- Must be over age 18,
- They must meet United Kingdom (UK) Brain Bank criteria for probable PD, or
- They must meet standard criteria for
- progressive supranuclear palsy (PSP),
- corticobasal degeneration (CBD),
Show all 15Show fewer
- multiple systems atrophy (MSA),
- vascular parkinsonism, or
- Lewy Body Dementia (LBD)
- Alzheimer's dementia (AD)
- Primary progressive aphasia
- Vascular dementia.
- Patients must be at high risk for poor outcomes as defined by the Brief Needs Assessment Tool (BNAT) which screens for psychosocial issues, symptoms, and caregiver burden.
- Caregivers will be identified by asking the patient: "Could (participant) tell us the one person who helps (participant) the most with (participant's) PD outside of clinic?"
- Caregivers may be self-identified in cases of severe dementia in order to obtain data relevant to this vulnerable and underrepresented group.
Who cannot join
- Unable or unwilling to commit to study procedures;
- Presence of additional chronic medical illnesses which may require palliative services (e.g. metastatic cancer); or
- Already receiving palliative care or hospice services.
- Not expecting to continue care with enrolled physician for at least 6 months.
- The investigators have purposefully kept our inclusion/exclusion criteria broad to allow for greater generalizability of results and to ensure inclusion of potentially underrepresented and understudied subgroups.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver
Aurora, Colorado, 80045
University of California, San Francisco
San Francisco, California, 94143
About this study
This is a two-center (University of Colorado, University of California San Francisco) community-based comparative effectiveness study of outpatient palliative care for Parkinson's disease (PD) and related disorders (progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), multiple systems atrophy (MSA), Lewy Body Dementia (LBD). In September 2018, the study was amended to also include Alzheimer's disease (AD) and related disorders (Frontotemporal Dementia (FTD), Primary Progressive Aphasia (PPA), Vascular Dementia). It will utilize a randomized stepped-wedge design to compare patient and caregiver outcomes between usual care in the community versus usual care augmented by palliative training and telemedicine support to provide other resources (e.g. social work).
Read the detailed description
Parkinson's disease (PD) is the second most common neurodegenerative illness affecting approximately 1.5 million Americans and is the 14th leading cause of death in the United States. PD is traditionally described as a movement disorder with characteristic motor symptoms (e.g. tremor). However, more recent research demonstrates the impact of nonmotor symptoms such as pain, depression, and dementia on mortality, quality of life (QOL), nursing home placement and caregiver distress. Regarding models of care for PD, evidence suggests that care including a neurologist results in lower mortality and nursing home placement than care solely from a primary care physician. Unfortunately, there is also significant evidence that many of the needs most important to PD patients and their caregivers (e.g. depression, planning for the future) are poorly addressed under current models of care. Palliative care is an approach to caring for individuals with life-threatening illnesses that focuses on addressing potential causes of suffering including physical and psychiatric symptoms, psychosocial issues and spiritual needs. While developed for cancer patients, palliative care approaches have been successfully applied in other chronic progressive illnesses including heart failure and pulmonary disease. To date there have been minimal attempts to apply these principles to PD although evidence suggests that PD patients' unmet needs under current models of care may be amenable to palliative care. A small but growing cadre of centers offer outpatient palliative care for PD with early evidence of efficacy and a randomized trial of an academic-based outpatient palliative care is underway led by investigators on this proposal. While this work is critical to forwarding this field, further work is needed to provide a model that can be widely disseminated. The current proposal addresses this gap by assessing the effectiveness and feasibility of a novel community-based intervention that empowers community neurology practices to improve care for PD patients and caregivers through palliative care training, coaching and telemedicine resources. The investigators hypothesize that this intervention will improve patient QOL and caregiver burden and will prove feasible and acceptable to community providers. The investigators Specific Aims are to: 1) Determine the a) effectiveness and b) feasibility of a novel community-based outpatient palliative care intervention for PD.; 2) Describe the effects of a this intervention on patient and caregiver costs and service utilization; and 3) Identify opportunities to optimize community-based palliative care for this population by: a) describing patient and caregiver characteristics associated with intervention benefits; and b) through direct patient, caregiver and provider interviews. Innovations of the investigators approach include a novel model of providing disease-specific community-based palliative care not dependent on limited palliative specialist resources, a stepped-wedge trial design and use of telemedicine resources to provide multidisciplinary care. The research is significant because it will create a foundation for future community-based dissemination studies in PD and the broader field of palliative care.
In September 2018, supplemental support from NIH was granted in order to explore outcomes among an Alzheimer's dementia population. Alzheimer's disease (AD) is the most common neurodegenerative illness affecting 10% of adults over age 65. This incurable and relentlessly progressive disease affects approximately 1.5 million Americans and is the 6th leading cause of death in the United States. Care for community-dwelling patients with AD is typically focused on the assessment and pharmacologic management of cognitive and behavioral symptoms, although there is growing recognition of the need to expand care to address other issues, including advance care planning. There is significant evidence that many of the most important needs of the AD patients and their caregivers are poorly addressed under current models of care, including management of medical and psychiatric symptoms (e.g. pain and depression), caregiver support, advance care planning, and spiritual wellbeing. Importantly, while the top goal of care for the majority of patients is avoidance of institutionalization, our current models of care invest more resources in institutionalized patients rather than proactively supporting community-dwelling individuals which may prevent institutionalization and reduce overall healthcare costs. Our supplemental study will thus additionally target this population for a 12-month period.
- Conditions
- Parkinson Disease, Parkinsonism, Lewy Body Disease, Supranuclear Palsy, Progressive, Parkinsonism Vascular, Multiple System Atrophy
- Being tested
- Palliative Care
- Keywords
- Palliative Care, Supportive Care, Movement Disorders, Brain Disease, Neurodegeneration, Parkinson's Disease, Alzheimer's Disease
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Lewy Body Disease, Supranuclear Palsy, Progressive, Multiple System Atrophy, Corticobasal Degeneration, Alzheimer Disease, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative CareBehavioural
Also called Supportive Care
Palliative care training for community neurologists and use of telemedicine for team-based support of patients
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Patients to get usual care from their established neurology care team that is enrolled in the study. |
| Standard of Care plus Palliative Care | Experimental | Patients to get usual care, augmented by palliative care, provided by their established neurology care team that is affiliated with the study, with additional support provided by the University of Colorado Denver Neurology Palliative Care team. Receives: Behavioral: Palliative Care |
| Clinicians | Experimental | Clinicians enrolled in the study will receive an 8-hour supportive and palliative care training, followed by monthly coaching and the availability of telemedicine visits for enrolled patients with the university neuro-palliative care team. The unit of randomization is the time when they receive training. Four to five clinical practices will receive training every 6 months during years 2 and 3, at which time all of their enrolled patients will be switched from usual care to the intervention arm. Receives: Behavioral: Palliative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Alzheimer's Disease (QOL-AD)
Measures of Quality of Life
Measured: Up to 48 months
Zarit Burden of Care Instrument (ZBI)
Measures of Care Partner Distress
Measured: Up to 48 months
Secondary outcomes (14)
McGill Quality of Life Questionnaire (MQOL)
Measures of Quality of Life
Measured: Up to 48 months
Hospital Anxiety and Depression Scale (HADS)
Measures of mood
Measured: Up to 48 months
Edmonton Symptom Assessment Scale (ESAS_PD)
Measures of symptom burden
Measured: Up to 48 months
Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-SP 12 Item)
Measures of spiritual wellbeing
Measured: Up to 48 months
Prolonged Grief Questionnaire (PG-12)
Measures of grief (sense of loss)
Measured: Up to 48 months
Semi-structured Qualitative Interview
Measures of participant views on the study including their outcomes and the implementation of this model of community-based palliative care.
Measured: At 12 months
Montreal Cognitive Assessment (MOCA)
Measures of cognitive function
Measured: At baseline
Healthcare Utilization Form
Measures of type and frequency of healthcare utilized
Measured: Up to 48 months
Palliative Performance Scale
Measures of Disease Severity
Measured: Up to 48 months
Clinical Global Impression of Change
Measures of change in disease burden
Measured: Up to 48 months
Treatment Documentation Form
Measures of treatments used for disease management
Measured: Up to 48 months
Modified Caregiver Strain Index
Measures of care partner distress
Measured: Up to 48 months
Needs at End of Life Screening Tool
Detects and measures needs for end of life
Measured: Up to 12 months
Neuropsychiatric Inventory
Measures dementia-related symptoms
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 Mar 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a stepped-wedge design, meaning that during the first year all patients enrolled will continue to receive usual care provided by their neurologist, who is also enrolled in the study. During years 2 and 3, every 6 months, 4-5 neurologists will receive training in supportive and palliative care. The timing of the training will be randomly assigned. Once their neurologist has received training, all of their enrolled patients will be switched to the intervention arm, and be eligible for additional care via telemedicine with the university supportive and palliative care team. During the final year of the study, all the neurologists will have received care, and all of their patients will be in the intervention arm. On a separate level, we will be evaluating the effects of training on the enrolled neurologists through assessments of palliative skills, knowledge, and attitudes before and after the training, as well as through qualitative interviews.
- Masking
- None (open label)
- Enrolment
- 783 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Benzi M Kluger, MD, MS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076671
- Sponsor's protocol ID
- 16-1400
- Other IDs
- R01NR016037-01A1
- Acronym
- MTMD
- Status last verified
- May 2021
- First submitted
- 7 Feb 2017
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yilmaz S, Aslam S, Sillau S, Katz M, Kluger B. Bridging the gap: Evaluating a community-based palliative care intervention for underserved patients with Parkinson's disease. Parkinsonism Relat Disord. 2026 May;146:108262. doi: 10.1016/j.parkreldis.2026.108262. Epub 2026 Mar 6.
PubMed 41812391Kluger BM, Katz M, Galifianakis NB, Pantilat SZ, Hauser JM, Khan R, Friedman C, Vaughan CL, Goto Y, Long SJ, Martin CS, Dini M, McQueen RB, Palmer L, Fairclough D, Seeberger LC, Sillau SH, Kutner JS. Patient and Family Outcomes of Community Neurologist Palliative Education and Telehealth Support in Parkinson Disease. JAMA Neurol. 2024 Jan 1;81(1):39-49. doi: 10.1001/jamaneurol.2023.4260.
PubMed 37955923Mahes A, Macchi ZA, Martin CS, Katz M, Galifianakis NB, Pantilat SZ, Kutner JS, Sillau S, Kluger BM. The "Surprise Question" for Prognostication in People With Parkinson's Disease and Related Disorders. J Pain Symptom Manage. 2024 Jan;67(1):e1-e7. doi: 10.1016/j.jpainsymman.2023.10.004. Epub 2023 Oct 13.
PubMed 37838080Ayele R, Macchi ZA, Dini M, Bock M, Katz M, Pantilat SZ, Jones J, Kluger BM. Experience of Community Neurologists Providing Care for Patients With Neurodegenerative Illness During the COVID-19 Pandemic. Neurology. 2021 Sep 7;97(10):e988-e995. doi: 10.1212/WNL.0000000000012363. Epub 2021 Jun 14.
PubMed 34489348Macchi ZA, Ayele R, Dini M, Lamira J, Katz M, Pantilat SZ, Jones J, Kluger BM. Lessons from the COVID-19 pandemic for improving outpatient neuropalliative care: A qualitative study of patient and caregiver perspectives. Palliat Med. 2021 Jul;35(7):1258-1266. doi: 10.1177/02692163211017383. Epub 2021 May 18.
PubMed 34006157
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- More Than a Movement Disorder: Applying Palliative Care to Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03076671
- Acronym / sponsor ID
- MTMD / 16-1400
- Conditions
- Parkinson Disease, Parkinsonism, Lewy Body Disease, Supranuclear Palsy, Progressive, Parkinsonism Vascular, Multiple System Atrophy
- Keywords
- Palliative Care, Supportive Care, Movement Disorders, Brain Disease, Neurodegeneration, Parkinson's Disease, Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 783 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of California, San Francisco
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-center (University of Colorado, University of California San Francisco) community-based comparative effectiveness study of outpatient palliative care for Parkinson's disease (PD) and related disorders (progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), multiple systems atrophy (MSA), Lewy Body Dementia (LBD). In September 2018, the study was amended to also include Alzheimer's disease (AD) and related disorders (Frontotemporal Dementia (FTD), Primary Progressive Aphasia (PPA), Vascular Dementia). It will utilize a randomized stepped-wedge design to compare patient and caregiver outcomes between usual care in the community versus usual care augmented by palliative training and telemedicine support to provide other resources (e.g. social work).
Detailed description
Parkinson's disease (PD) is the second most common neurodegenerative illness affecting approximately 1.5 million Americans and is the 14th leading cause of death in the United States. PD is traditionally described as a movement disorder with characteristic motor symptoms (e.g. tremor). However, more recent research demonstrates the impact of nonmotor symptoms such as pain, depression, and dementia on mortality, quality of life (QOL), nursing home placement and caregiver distress. Regarding models of care for PD, evidence suggests that care including a neurologist results in lower mortality and nursing home placement than care solely from a primary care physician. Unfortunately, there is also significant evidence that many of the needs most important to PD patients and their caregivers (e.g. depression, planning for the future) are poorly addressed under current models of care. Palliative care is an approach to caring for individuals with life-threatening illnesses that focuses on addressing potential causes of suffering including physical and psychiatric symptoms, psychosocial issues and spiritual needs. While developed for cancer patients, palliative care approaches have been successfully applied in other chronic progressive illnesses including heart failure and pulmonary disease. To date there have been minimal attempts to apply these principles to PD although evidence suggests that PD patients' unmet needs under current models of care may be amenable to palliative care. A small but growing cadre of centers offer outpatient palliative care for PD with early evidence of efficacy and a randomized trial of an academic-based outpatient palliative care is underway led by investigators on this proposal. While this work is critical to forwarding this field, further work is needed to provide a model that can be widely disseminated. The current proposal addresses this gap by assessing the effectiveness and feasibility of a novel community-based intervention that empowers community neurology practices to improve care for PD patients and caregivers through palliative care training, coaching and telemedicine resources. The investigators hypothesize that this intervention will improve patient QOL and caregiver burden and will prove feasible and acceptable to community providers. The investigators Specific Aims are to: 1) Determine the a) effectiveness and b) feasibility of a novel community-based outpatient palliative care intervention for PD.; 2) Describe the effects of a this intervention on patient and caregiver costs and service utilization; and 3) Identify opportunities to optimize community-based palliative care for this population by: a) describing patient and caregiver characteristics associated with intervention benefits; and b) through direct patient, caregiver and provider interviews. Innovations of the investigators approach include a novel model of providing disease-specific community-based palliative care not dependent on limited palliative specialist resources, a stepped-wedge trial design and use of telemedicine resources to provide multidisciplinary care. The research is significant because it will create a foundation for future community-based dissemination studies in PD and the broader field of palliative care.
In September 2018, supplemental support from NIH was granted in order to explore outcomes among an Alzheimer's dementia population. Alzheimer's disease (AD) is the most common neurodegenerative illness affecting 10% of adults over age 65. This incurable and relentlessly progressive disease affects approximately 1.5 million Americans and is the 6th leading cause of death in the United States. Care for community-dwelling patients with AD is typically focused on the assessment and pharmacologic management of cognitive and behavioral symptoms, although there is growing recognition of the need to expand care to address other issues, including advance care planning. There is significant evidence that many of the most important needs of the AD patients and their caregivers are poorly addressed under current models of care, including management of medical and psychiatric symptoms (e.g. pain and depression), caregiver support, advance care planning, and spiritual wellbeing. Importantly, while the top goal of care for the majority of patients is avoidance of institutionalization, our current models of care invest more resources in institutionalized patients rather than proactively supporting community-dwelling individuals which may prevent institutionalization and reduce overall healthcare costs. Our supplemental study will thus additionally target this population for a 12-month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a stepped-wedge design, meaning that during the first year all patients enrolled will continue to receive usual care provided by their neurologist, who is also enrolled in the study. During years 2 and 3, every 6 months, 4-5 neurologists will receive training in supportive and palliative care. The timing of the training will be randomly assigned. Once their neurologist has received training, all of their enrolled patients will be switched to the intervention arm, and be eligible for additional care via telemedicine with the university supportive and palliative care team. During the final year of the study, all the neurologists will have received care, and all of their patients will be in the intervention arm. On a separate level, we will be evaluating the effects of training on the enrolled neurologists through assessments of palliative skills, knowledge, and attitudes before and after the training, as well as through qualitative interviews.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Patients to get usual care from their established neurology care team that is enrolled in the study. |
| Standard of Care plus Palliative Care | Experimental | Behavioral: Palliative CarePatients to get usual care, augmented by palliative care, provided by their established neurology care team that is affiliated with the study, with additional support provided by the University of Colorado Denver Neurology Palliative Care team. |
| Clinicians | Experimental | Behavioral: Palliative CareClinicians enrolled in the study will receive an 8-hour supportive and palliative care training, followed by monthly coaching and the availability of telemedicine visits for enrolled patients with the university neuro-palliative care team. The unit of randomization is the time when they receive training. Four to five clinical practices will receive training every 6 months during years 2 and 3, at which time all of their enrolled patients will be switched from usual care to the intervention arm. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must be fluent English Speakers,
- Must be over age 18,
- They must meet United Kingdom (UK) Brain Bank criteria for probable PD, or
- They must meet standard criteria for
- Patients must be at high risk for poor outcomes as defined by the Brief Needs Assessment Tool (BNAT) which screens for psychosocial issues, symptoms, and caregiver burden.
Key exclusion criteria (5 listed)
- Unable or unwilling to commit to study procedures;
- Presence of additional chronic medical illnesses which may require palliative services (e.g. metastatic cancer); or
- Already receiving palliative care or hospice services.
- Not expecting to continue care with enrolled physician for at least 6 months.
- The investigators have purposefully kept our inclusion/exclusion criteria broad to allow for greater generalizability of results and to ensure inclusion of potentially underrepresented and understudied subgroups.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative CareAlso: Supportive CarePalliative care training for community neurologists and use of telemedicine for team-based support of patients | Behavioural | Clinicians, Standard of Care plus Palliative Care |
Primary outcome
Quality of Life Alzheimer's Disease (QOL-AD)
Time frame: Up to 48 months
Measures of Quality of Life
Zarit Burden of Care Instrument (ZBI)
Time frame: Up to 48 months
Measures of Care Partner Distress
14 secondary outcomes
McGill Quality of Life Questionnaire (MQOL)
Time frame: Up to 48 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: Up to 48 months
Edmonton Symptom Assessment Scale (ESAS_PD)
Time frame: Up to 48 months
Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-SP 12 Item)
Time frame: Up to 48 months
Prolonged Grief Questionnaire (PG-12)
Time frame: Up to 48 months
Semi-structured Qualitative Interview
Time frame: At 12 months
Montreal Cognitive Assessment (MOCA)
Time frame: At baseline
Healthcare Utilization Form
Time frame: Up to 48 months
Palliative Performance Scale
Time frame: Up to 48 months
Clinical Global Impression of Change
Time frame: Up to 48 months
Treatment Documentation Form
Time frame: Up to 48 months
Modified Caregiver Strain Index
Time frame: Up to 48 months
Needs at End of Life Screening Tool
Time frame: Up to 12 months
Neuropsychiatric Inventory
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Derived from this study: PubMed 41812391Yilmaz S, Aslam S, Sillau S, Katz M, Kluger B. Bridging the gap: Evaluating a community-based palliative care intervention for underserved patients with Parkinson's disease. Parkinsonism Relat Disord. 2026 May;146:108262. doi: 10.1016/j.parkreldis.2026.108262. Epub 2026 Mar 6.
- Derived from this study: PubMed 37955923Kluger BM, Katz M, Galifianakis NB, Pantilat SZ, Hauser JM, Khan R, Friedman C, Vaughan CL, Goto Y, Long SJ, Martin CS, Dini M, McQueen RB, Palmer L, Fairclough D, Seeberger LC, Sillau SH, Kutner JS. Patient and Family Outcomes of Community Neurologist Palliative Education and Telehealth Support in Parkinson Disease. JAMA Neurol. 2024 Jan 1;81(1):39-49. doi: 10.1001/jamaneurol.2023.4260.
- Derived from this study: PubMed 37838080Mahes A, Macchi ZA, Martin CS, Katz M, Galifianakis NB, Pantilat SZ, Kutner JS, Sillau S, Kluger BM. The "Surprise Question" for Prognostication in People With Parkinson's Disease and Related Disorders. J Pain Symptom Manage. 2024 Jan;67(1):e1-e7. doi: 10.1016/j.jpainsymman.2023.10.004. Epub 2023 Oct 13.
- Derived from this study: PubMed 34489348Ayele R, Macchi ZA, Dini M, Bock M, Katz M, Pantilat SZ, Jones J, Kluger BM. Experience of Community Neurologists Providing Care for Patients With Neurodegenerative Illness During the COVID-19 Pandemic. Neurology. 2021 Sep 7;97(10):e988-e995. doi: 10.1212/WNL.0000000000012363. Epub 2021 Jun 14.
- Derived from this study: PubMed 34006157Macchi ZA, Ayele R, Dini M, Lamira J, Katz M, Pantilat SZ, Jones J, Kluger BM. Lessons from the COVID-19 pandemic for improving outpatient neuropalliative care: A qualitative study of patient and caregiver perspectives. Palliat Med. 2021 Jul;35(7):1258-1266. doi: 10.1177/02692163211017383. Epub 2021 May 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benzi M Kluger, MD, MS principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Care in people with Parkinson Disease and Parkinsonism, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Alzheimer's Disease (QOL-AD) (time frame: Up to 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03076671, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.