Parkinson's Disease
Conditions
Keywords
Palliative Care, Parkinson's Disease
Brief summary
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.
Detailed description
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.
Interventions
OTHERInterdisciplinary 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.
OTHERStandard of Care
Usual care defined as including both a PCP and neurologist
Sponsors
University of California, San Francisco
University of Alberta
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fluent in English * UK Brain Bank criteria for diagnosis of probable PD or Multiple Systems Atrophy (MSA) or Corticobasal Degeneration (CBD) or Progressive Supranuclear Palsy (PSP) or Lewy Body Dementia (LBD) * At high risk for poor outcomes as identified by the Palliative Care Needs Assessment Tool (PC-NAT)
Exclusion criteria
* Immediate and urgent palliative care needs * Unable or unwilling to commit to study procedures including; 1. randomization, 2. study visits or 3. the addition of a neurologist to their care team * Presence of additional chronic medical illnesses which may require palliative services * Already receiving palliative care and/or hospice services.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Subjects Quality of Life (QOL) | 0 to 6 months | 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. |
| Changes in Caregiver Distress | 0 to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Patient Anxiety | 0 to 6 months | 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. |
| Changes in Patient Depression | 0 to 6 months | 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. |
| Changes in Caregiver Anxiety | 0 to 6 months | 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. |
| Changes in Caregiver Depression | 0 to 6 months | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 104 |
| 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. | 106 |
| Total | 210 |
Baseline characteristics
| Characteristic | Standard of Care | Interdisciplinary Outpatient Palliative Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 84 Participants | 80 Participants | 164 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 26 Participants | 45 Participants |
| Age, Continuous | 70.71 years STANDARD_DEVIATION 8.04 | 69.52 years STANDARD_DEVIATION 8.25 | 70.11 years STANDARD_DEVIATION 8.15 |
| Disease Duration | 114.34 months STANDARD_DEVIATION 79.17 | 116.48 months STANDARD_DEVIATION 83.7 | 115.42 months STANDARD_DEVIATION 81.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants | 103 Participants | 203 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Hoehn and Yar 1 | 0 Participants | 0 Participants | 0 Participants |
| Hoehn and Yar 1.5 | 0 Participants | 2 Participants | 2 Participants |
| Hoehn and Yar 2 | 34 Participants | 25 Participants | 59 Participants |
| Hoehn and Yar 2.5 | 30 Participants | 24 Participants | 54 Participants |
| Hoehn and Yar 3 | 15 Participants | 25 Participants | 40 Participants |
| Hoehn and Yar 4 | 12 Participants | 14 Participants | 26 Participants |
| Hoehn and Yar 5 | 9 Participants | 14 Participants | 23 Participants |
| Hoehn and Yar Missing | 4 Participants | 2 Participants | 6 Participants |
| Hospital Anxiety and Depression Scale (HADS) - Caregiver Anxiety | 7.72 units on a scale STANDARD_DEVIATION 3.57 | 7.14 units on a scale STANDARD_DEVIATION 3.58 | 7.43 units on a scale STANDARD_DEVIATION 3.58 |
| Hospital Anxiety and Depression Scale (HADS) - Caregiver Depression | 4.09 units on a scale STANDARD_DEVIATION 2.79 | 4.50 units on a scale STANDARD_DEVIATION 3.34 | 4.30 units on a scale STANDARD_DEVIATION 3.07 |
| Hospital Anxiety and Depression Scale (HADS) - Patient Anxiety | 7.73 units on a scale STANDARD_DEVIATION 4.43 | 7.57 units on a scale STANDARD_DEVIATION 3.78 | 7.65 units on a scale STANDARD_DEVIATION 4.11 |
| Hospital Anxiety and Depression Scale (HADS) - Patient Depression | 7.23 units on a scale STANDARD_DEVIATION 3.74 | 7.04 units on a scale STANDARD_DEVIATION 3.55 | 7.13 units on a scale STANDARD_DEVIATION 3.64 |
| Montreal Cognitive Assessment (MoCA) Test for Dementia | 23.66 units on a scale STANDARD_DEVIATION 5.08 | 23.96 units on a scale STANDARD_DEVIATION 4.83 | 23.81 units on a scale STANDARD_DEVIATION 4.95 |
| Presence of Caregiver | 88 Participants | 87 Participants | 175 Participants |
| Presence of Dementia | 30 Participants | 30 Participants | 60 Participants |
| Quality of Life AD (QOL-AD) | 34.29 units on a scale STANDARD_DEVIATION 5.6 | 33.89 units on a scale STANDARD_DEVIATION 5.69 | 34.09 units on a scale STANDARD_DEVIATION 5.64 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 93 Participants | 100 Participants | 193 Participants |
| Region of Enrollment Canada | 33 participants | 34 participants | 67 participants |
| Region of Enrollment United States | 71 participants | 72 participants | 143 participants |
| Sex: Female, Male Female | 34 Participants | 41 Participants | 75 Participants |
| Sex: Female, Male Male | 70 Participants | 65 Participants | 135 Participants |
| Zarit Burden of Care (ZBI) | 31.27 units on a scale STANDARD_DEVIATION 8.06 | 32.33 units on a scale STANDARD_DEVIATION 8.19 | 31.80 units on a scale STANDARD_DEVIATION 8.12 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 104 | 5 / 106 |
| other Total, other adverse events | 1 / 104 | 3 / 106 |
| serious Total, serious adverse events | 1 / 104 | 0 / 106 |
Outcome results
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.
Time frame: 0 to 6 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Changes in Caregiver Distress | -1.2031 score on a scale |
| Interdisciplinary Outpatient Palliative Care | Changes in Caregiver Distress | -2.3267 score on a scale |
Comparison: Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.p-value: 0.176195% CI: [-2.7569, 0.5097]Mixed Models Analysis
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.
Time frame: 0 to 6 months
Population: Available case data for for QOL AD. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Changes in the Subjects Quality of Life (QOL) | -0.8446 score on a scale |
| Interdisciplinary Outpatient Palliative Care | Changes in the Subjects Quality of Life (QOL) | 0.6576 score on a scale |
Comparison: Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.p-value: 0.027295% CI: [0.1706, 2.8338]Mixed Models Analysis
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.
Time frame: 0 to 6 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Changes in Caregiver Anxiety | -0.5216 score on a scale |
| Interdisciplinary Outpatient Palliative Care | Changes in Caregiver Anxiety | -1.2095 score on a scale |
Comparison: Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.p-value: 0.152995% CI: [-1.6338, 0.2581]Mixed Models Analysis
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.
Time frame: 0 to 6 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Changes in Caregiver Depression | -0.1969 score on a scale |
| Interdisciplinary Outpatient Palliative Care | Changes in Caregiver Depression | -0.3576 score on a scale |
Comparison: Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.p-value: 0.683495% CI: [-0.9382, 0.6167]Mixed Models Analysis
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.
Time frame: 0 to 6 months
Population: Available case data for for HADS Anxiety. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Changes in Patient Anxiety | -0.7318 score on a scale |
| Interdisciplinary Outpatient Palliative Care | Changes in Patient Anxiety | -1.1933 score on a scale |
Comparison: Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.p-value: 0.236995% CI: [-1.2291, 0.3059]Mixed Models Analysis
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.
Time frame: 0 to 6 months
Population: Available case data for for HADS Depression. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Changes in Patient Depression | -0.2041 score on a scale |
| Interdisciplinary Outpatient Palliative Care | Changes in Patient Depression | -0.3351 score on a scale |
p-value: 0.748495% CI: [-0.9349, 0.673]Mixed Models Analysis