Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| University of Alberta | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to improve outcomes for persons living with Parkinson's Disease (PD) and their family caregivers. The investigators hypothesize that outpatient interdisciplinary palliative care will improve patient-centered outcomes for PD patients at high-risk for poor outcomes.
Palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease. To date there have been minimal attempts to apply these principles to PD although preliminary evidence suggests that PD patients have significant unmet needs under current models of care which may be amenable through a palliative care model. This study will provide critical information to forward this field including data on the comparative effectiveness of outpatient palliative care for PD versus current standards of care; effects of this intervention on cost and service utilization; and the characteristics of patients most likely to benefit from such an approach and the specific services most needed by PD patients and their caregivers.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Other | Usual care as in including both a Primary Care Physician (PCP) and neurologist. |
|
| Interdisciplinary outpatient palliative care | Active Comparator | Usual care augmented by an outpatient interdisciplinary palliative care team. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interdisciplinary outpatient palliative care | Other | Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Subjects Quality of Life (QOL) | The QOL-AD (Quality of Life in Alzheimer's Disease) survey will be used to measure the differences in the quality of life between groups.Higher numbers indicate better outcomes. The scale ranges from 4 to 52. | 0 to 6 months |
| Changes in Caregiver Distress | The Zarit Caregiver Burden Interview Form (ZBI) will be used to measure differences in Caregiver Distress between groups. Higher scores indicate worse outcomes. Scale ranges from 0 to 48. | 0 to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Patient Anxiety | The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in patient anxiety. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21. | 0 to 6 months |
| Changes in Patient Depression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Immediate and urgent palliative care needs
Unable or unwilling to commit to study procedures including;
Presence of additional chronic medical illnesses which may require palliative services
Already receiving palliative care and/or hospice services.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Benzi Kluger | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| University of Colorado Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34992965 | Derived | Macchi ZA, Miyasaki J, Katz M, Galifianakis N, Sillau S, Kluger BM. Prevalence and Cumulative Incidence of Caregiver-Reported Aggression in Advanced Parkinson Disease and Related Disorders. Neurol Clin Pract. 2021 Dec;11(6):e826-e833. doi: 10.1212/CPJ.0000000000001110. | |
| 34818097 | Derived | Koljack CE, Miyasaki J, Prizer LP, Katz M, Galifianakis N, Sillau SH, Kluger BM. Predictors of Spiritual Well-Being in Family Caregivers for Individuals with Parkinson's Disease. J Palliat Med. 2022 Apr;25(4):606-613. doi: 10.1089/jpm.2020.0797. Epub 2021 Nov 24. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Usual care as in including both a Primary Care Physician (PCP) and neurologist. Standard of Care: Usual care defined as including both a PCP and neurologist |
| FG001 | Interdisciplinary Outpatient Palliative Care | Usual care augmented by an outpatient interdisciplinary palliative care team. Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Usual care as in including both a Primary Care Physician (PCP) and neurologist. Standard of Care: Usual care defined as including both a PCP and neurologist |
| BG001 | Interdisciplinary Outpatient Palliative Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age data was missing for one person. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in the Subjects Quality of Life (QOL) | The QOL-AD (Quality of Life in Alzheimer's Disease) survey will be used to measure the differences in the quality of life between groups.Higher numbers indicate better outcomes. The scale ranges from 4 to 52. | Available case data for for QOL AD. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months. | Posted | Mean | 95% Confidence Interval | score on a scale | 0 to 6 months |
|
1 year, or for as long as the patient was in the study if they discontinued early.
Coordinators asked patients about common adverse events, including falls and hospitalizations, at every study visit.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | Usual care as in including both a Primary Care Physician (PCP) and neurologist. Standard of Care: Usual care defined as including both a PCP and neurologist |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left proximal humerus fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bradycardia | Cardiac disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benzi Kluger, MD, MS, Principal Investigator | University of Colorado | 303-724-2194 | Benzi.kluger@ucdenver.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2017 | Jan 10, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard of Care | Other | Usual care defined as including both a PCP and neurologist |
|
The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in patient depression. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21.
| 0 to 6 months |
| Changes in Caregiver Anxiety | The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in caregiver anxiety. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21. | 0 to 6 months |
| Changes in Caregiver Depression | The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in caregiver depression. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21. | 0 to 6 months |
| Aurora |
| Colorado |
| 80045 |
| United States |
| University of Alberta Canada | Edmonton | Alberta | T6G 2E1 | Canada |
| 32040141 | Derived | Kluger BM, Miyasaki J, Katz M, Galifianakis N, Hall K, Pantilat S, Khan R, Friedman C, Cernik W, Goto Y, Long J, Fairclough D, Sillau S, Kutner JS. Comparison of Integrated Outpatient Palliative Care With Standard Care in Patients With Parkinson Disease and Related Disorders: A Randomized Clinical Trial. JAMA Neurol. 2020 May 1;77(5):551-560. doi: 10.1001/jamaneurol.2019.4992. |
Usual care augmented by an outpatient interdisciplinary palliative care team.
Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease.
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Age data were not available for one participant in the "Standard of Care" Arm | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Presence of Dementia | Count of Participants | Participants |
|
| Presence of Caregiver | Count of Participants | Participants |
|
| Disease Duration | Mean | Standard Deviation | months |
|
| Quality of Life AD (QOL-AD) | Higher numbers indicate better outcomes. Scale ranges from 0 to 52. | Mean | Standard Deviation | units on a scale |
|
| Zarit Burden of Care (ZBI) | Applies only to caregivers. Higher numbers indicate worse outcomes. Scale ranges from 0 to 48. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression Scale (HADS) - Patient Anxiety | Higher numbers indicate worse outcomes. Scale ranges from 0 to 21. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression Scale (HADS) - Patient Depression | Higher numbers indicate worse outcomes. Scale ranges from 0 to 21. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression Scale (HADS) - Caregiver Anxiety | Only applicable to caregivers. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression Scale (HADS) - Caregiver Depression | Only applicable to caregivers. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21. | Mean | Standard Deviation | units on a scale |
|
| Montreal Cognitive Assessment (MoCA) Test for Dementia | Higher numbers indicate better outcomes. Scale ranges from 0 to 30. | Mean | Standard Deviation | units on a scale |
|
| Hoehn and Yar | Higher numbers indicate greater severity of Parkinson's disease. | Count of Participants | Participants |
|
Usual care augmented by an outpatient interdisciplinary palliative care team. Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease. |
|
|
|
| Primary | Changes in Caregiver Distress | The Zarit Caregiver Burden Interview Form (ZBI) will be used to measure differences in Caregiver Distress between groups. Higher scores indicate worse outcomes. Scale ranges from 0 to 48. | Available case data for for ZBI. Applicable only when a caregiver is present. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months. | Posted | Mean | 95% Confidence Interval | score on a scale | 0 to 6 months |
|
|
|
|
| Secondary | Changes in Patient Anxiety | The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in patient anxiety. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21. | Available case data for for HADS Anxiety. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months. | Posted | Mean | 95% Confidence Interval | score on a scale | 0 to 6 months |
|
|
|
|
| Secondary | Changes in Patient Depression | The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in patient depression. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21. | Available case data for for HADS Depression. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months. | Posted | Mean | 95% Confidence Interval | score on a scale | 0 to 6 months |
|
|
|
|
| Secondary | Changes in Caregiver Anxiety | The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in caregiver anxiety. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21. | Available case data for for HADS Anxiety for caregiver. Only applicable when a caregiver is present. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months. | Posted | Mean | 95% Confidence Interval | score on a scale | 0 to 6 months |
|
|
|
|
| Secondary | Changes in Caregiver Depression | The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in caregiver depression. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21. | Available case data for for HADS Anxiety for caregiver. Only applicable when a caregiver is present. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months. | Posted | Mean | 95% Confidence Interval | score on a scale | 0 to 6 months |
|
|
|
|
| 2 |
| 104 |
| 1 |
| 104 |
| 1 |
| 104 |
| EG001 | Interdisciplinary Outpatient Palliative Care | Usual care augmented by an outpatient interdisciplinary palliative care team. Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease. | 5 | 106 | 0 | 106 | 3 | 106 |
| Left femoral head fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| substernal pain/ DOE/SOB | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Facial fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Infection secondary to PEG tube insertion | Infections and infestations | Non-systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 2 |
|
| 2.5 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| Missing |
|