Atypical Parkinson Disease, Corticobasal Syndrome, Dementia With Lewy Bodies, Multiple System Atrophy, Progressive Supranuclear Palsy
Conditions
Brief summary
Progressive Supranuclear Palsy and related disorders (PRD) are debilitating, costly, and understudied conditions. Improving access to comprehensive, specialized, in-home patient care offers the potential to minimize the downward spiral of morbidity and preventable healthcare utilization. The aim of this study is to test whether and to what degree an interdisciplinary home visit program will improve patient- and caregiver-reported outcomes, and to identify unmet needs in this population.
Detailed description
Participants can elect to complete either the Home Visit Arm of the study or the Usual Care Arm of the study. Home Visit Arm: This interdisciplinary home visit program consists of 4 visits to patients' homes over the course of one year from a team of a movement disorders doctor, a nurse, a research coordinator, and a social worker. The team will come to a patient's home and assess the needs of both the patient and caregiver (if present), and connect the patient with any needed services. These visits can replace or be in addition to seeing another movement disorders doctor. Usual Care Arm: The information collected from the home visit participants will be compared to data collected from participants who elect to complete the usual care arm of the study. These participants and their caregivers (if available) will be invited to complete an online version of the survey. They will be contacted 12 months after their initial completion of the survey to complete a follow-up survey.
Interventions
BEHAVIORALHome Visit Program
Informed consent discussion, documentation; UPDRS I-IV, medical history, vitals, medication reconciliation, patient medical history and comorbidities; home safety assessment; psychosocial assessment of dyad, resource utilization questionnaire, caregiver medical history and comorbidities, MCSI; patient and caregiver short MoCA, satisfaction surveys, EQ5D; counseling, summarizing plan of care
BEHAVIORALUsual Care/Online Survey
Patients and caregivers, if available, will be asked to complete an online survey that asks about demographics, disease history, resource utilization, and unmet needs. The will be asked to complete a follow-up survey 12 months after completion of the initial survey.
Sponsors
Rush University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects will be those diagnosed with progressive supranuclear palsy, multiple system atrophy, corticobasal syndrome , Dementia with Lewy Bodies (DLB), or atypical parkinsonism without mention of idiopathic Parkinson's disease. * Subjects must be English speaking. Additional Inclusion Criteria For the Home Care Arm: * Each subject must either 1) be willing and able to provide written, informed consent for the study, and for whom capacity to consent will be assessed, or 2) if unable to provide informed consent due to lack of capacity, a caregiver is able to provide informed consent and the subject provides assent to participation. * Subjects must be homebound according to the Medicare definition: Leaving your home isn't recommended because of your condition; your condition keeps you from leaving home without help (such as using a wheelchair or walker, needing special transportation, or getting help from another person); leaving home takes a considerable and taxing effort. (http://www.medicare.gov/pubs/pdf/10969.pdf) * Subjects reside in Chicago at the time of Visit 1. * The Subject must reside independently at the time of Visit 1. * Subjects have one or more of the following criteria: fluctuation, multi-morbidity, mismanages medication, cognitive impairment, symptoms of depression and/or anxiety, high risk for re-hospitalization, high risk for nursing facility admission, suspected elder abuse, recent history of increased falls in home, caregiver burnout suspected * Ability to participate in the research study as deemed by the Principal Investigator. Additional Inclusion Criteria For the Usual Care Arm: * Independent access to an internet-connected computer in order to complete online survey * Valid email address * Each subject must review and acknowledge their ability to provide informed consent for the study via the first screen of the online survey
Exclusion criteria
* Diagnosis of idiopathic Parkinson's Disease * Diagnosis of another neurodegenerative disease * Subjects with active psychosis or exhibiting symptoms of a severe psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Between Baseline (Visit 1) and 1 Year (Visit 4) | 1 year | This scale is a brief, 6-item instrument measuring five specific domains of health-related quality of life (mobility, self-care, activities of daily living, anxiety/depression, pain/discomfort) and overall well-being. Items are scored on a 1-5 scale, with 5 indicating the highest level of perceived problems. Scores at Visits 1 and 4 will be compared. |
| Change in Overall Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Visual Analog Scale Item Between Baseline (Visit 1) and 1 Year (Visit 4) | 1 year | This item is a 0-100 point visual analog scale for rating overall quality of life where 0 is the worst and 100 the best health you can imagine. Scores at Visits 1 and 4 will be compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Strain as Measured by the Multidimensional Caregiver Strain Index (MCSI) Between Baseline (Visit 1) and 1 Year (Visit 4) | 1 year | An 18-item tool measuring subjective response to stressors. Respondents are asked about the frequency with which items apply, ranging from never to all of the time on a 5 point scale. The range is from 0 to 72, where higher scores indicate higher levels of caregiver strain, and scores in the 20-29 range are categorized as moderate strain, and scores 30 or higher are categorized as severe strain. Scores at Visits 1-4 will be compared. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF) | 1 year | A 9-item instrument developed within the field of social work to assess client satisfaction with multidisciplinary programs like the home visit program in this study. Each item is scored on a 1-7 scale, for a total possible raw score of 7-63, scaled to 0-100% of the possible score, with higher scores indicating greater client satisfaction. This measure will be completed at our last home visit (Visit 4). |
| Caregiver Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF) | 1 year | A 9-item instrument developed within the field of social work to assess client satisfaction with multidisciplinary programs like the home visit program in this study. Each item is scored on a 1-7 scale, for a total possible raw score of 7-63, scaled to 0-100% of the possible score, with higher scores indicating greater client satisfaction. This measure will be completed at our last home visit (Visit 4). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Home Visit Arm Participants will be asked to participate in four study visits, which will involve in-home clinical assessments, a needs assessment, and completion of some questionnaires. Additional information will be obtained from patients' routine medical records: their medical and medication history, family history, neurological examination findings, and office visit records.
\[Completion of Home Visit Program\]
Home Visit Program: Informed consent discussion, documentation; UPDRS I-IV, medical history, vitals, medication reconciliation, patient medical history and comorbidities; home safety assessment; psychosocial assessment of dyad, resource utilization questionnaire, caregiver medical history and comorbidities, MCSI; patient and caregiver short MoCA, satisfaction surveys, EQ5D; counseling, summarizing plan of care | 20 |
| Usual Care Arm (NOT RANDOMIZED) Participants will be asked to complete an initial online survey. Twelve months later, patients will be asked to complete an online follow-up survey.
\[Completion of Usual Care/Online Survey\]
Usual Care/Online Survey: Patients will be asked to complete an online survey that asks about demographics, disease history, resource utilization, and unmet needs. The will be asked to complete a follow-up survey 12 months after completion of the initial survey. | 34 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 4 |
| Overall Study | Lost to Follow-up | 0 | 16 |
Baseline characteristics
| Characteristic | Home Visit Arm | Total | Usual Care Arm (NOT RANDOMIZED) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 45 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 9 Participants | 6 Participants |
| Age, Continuous | 73.2 years STANDARD_DEVIATION 8.1 | 72.3 years STANDARD_DEVIATION 7.8 | 71.7 years STANDARD_DEVIATION 7.7 |
| Diagnosis Atypical parkinsonism | 2 Participants | 6 Participants | 4 Participants |
| Diagnosis Corticobasal Syndrome | 3 Participants | 5 Participants | 2 Participants |
| Diagnosis Multiple System Atrophy | 7 Participants | 12 Participants | 5 Participants |
| Diagnosis Progressive Supranuclear Palsy | 8 Participants | 31 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 50 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 17 Participants | 50 Participants | 33 Participants |
| Region of Enrollment United States | 20 participants | 54 participants | 34 participants |
| Self-reported homebound status | 20 Participants | 49 Participants | 29 Participants |
| Sex: Female, Male Female | 13 Participants | 28 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 26 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 20 | 4 / 36 |
| other Total, other adverse events | 0 / 20 | 0 / 36 |
| serious Total, serious adverse events | 0 / 20 | 0 / 36 |
Outcome results
Primary
Change in Overall Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Visual Analog Scale Item Between Baseline (Visit 1) and 1 Year (Visit 4)
This item is a 0-100 point visual analog scale for rating overall quality of life where 0 is the worst and 100 the best health you can imagine. Scores at Visits 1 and 4 will be compared.
Time frame: 1 year
Population: In the home visit arm, six patients died between visits 1 and 4, yielding a cohort of 14 patients available to complete surveys at visit 4. Five of the 14 did not complete the visual analog scale.~In the usual care arm, only sixteen participants responded to at least one survey at month 12, however six of the 16 did not complete the visual analog scale; the remainder were lost to follow-up despite multiple attempts to reach them via email over a period of weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Visit Arm | Change in Overall Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Visual Analog Scale Item Between Baseline (Visit 1) and 1 Year (Visit 4) | -1.43 score on a scale | Standard Deviation 38.85 |
| Usual Care Arm (NOT RANDOMIZED) | Change in Overall Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Visual Analog Scale Item Between Baseline (Visit 1) and 1 Year (Visit 4) | 4.81 score on a scale | Standard Deviation 23.82 |
p-value: 0.59t-test, 2 sided
Primary
Change in Patient Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Between Baseline (Visit 1) and 1 Year (Visit 4)
This scale is a brief, 6-item instrument measuring five specific domains of health-related quality of life (mobility, self-care, activities of daily living, anxiety/depression, pain/discomfort) and overall well-being. Items are scored on a 1-5 scale, with 5 indicating the highest level of perceived problems. Scores at Visits 1 and 4 will be compared.
Time frame: 1 year
Population: In the home visit arm, six patients died between visits 1 and 4, yielding a cohort of 14 patients available to complete surveys at visit 4.~In the usual care arm, only sixteen participants responded to at least one survey at month 12; the remainder were lost to follow-up despite multiple attempts to reach them via email over a period of weeks.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Home Visit Arm | Change in Patient Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Between Baseline (Visit 1) and 1 Year (Visit 4) | Self-care | 0.5 units on a scale |
| Home Visit Arm | Change in Patient Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Between Baseline (Visit 1) and 1 Year (Visit 4) | Anxiety/depression | 0 units on a scale |
| Home Visit Arm | Change in Patient Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Between Baseline (Visit 1) and 1 Year (Visit 4) | Activities of daily living | 1 units on a scale |
| Home Visit Arm | Change in Patient Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Between Baseline (Visit 1) and 1 Year (Visit 4) | Pain/discomfort | 0 units on a scale |
| Home Visit Arm | Change in Patient Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Between Baseline (Visit 1) and 1 Year (Visit 4) | Mobility | 1 units on a scale |
| Usual Care Arm (NOT RANDOMIZED) | Change in Patient Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Between Baseline (Visit 1) and 1 Year (Visit 4) | Pain/discomfort | 0 units on a scale |
| Usual Care Arm (NOT RANDOMIZED) | Change in Patient Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Between Baseline (Visit 1) and 1 Year (Visit 4) | Mobility | 0.5 units on a scale |
| Usual Care Arm (NOT RANDOMIZED) | Change in Patient Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Between Baseline (Visit 1) and 1 Year (Visit 4) | Self-care | 0 units on a scale |
| Usual Care Arm (NOT RANDOMIZED) | Change in Patient Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Between Baseline (Visit 1) and 1 Year (Visit 4) | Activities of daily living | 0 units on a scale |
| Usual Care Arm (NOT RANDOMIZED) | Change in Patient Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Between Baseline (Visit 1) and 1 Year (Visit 4) | Anxiety/depression | 0 units on a scale |
Comparison: Within-group paired t-tests and between-group paired t-testsp-value: 0.59Wilcoxon (Mann-Whitney)
Secondary
Change in Caregiver Strain as Measured by the Multidimensional Caregiver Strain Index (MCSI) Between Baseline (Visit 1) and 1 Year (Visit 4)
An 18-item tool measuring subjective response to stressors. Respondents are asked about the frequency with which items apply, ranging from never to all of the time on a 5 point scale. The range is from 0 to 72, where higher scores indicate higher levels of caregiver strain, and scores in the 20-29 range are categorized as moderate strain, and scores 30 or higher are categorized as severe strain. Scores at Visits 1-4 will be compared.
Time frame: 1 year
Population: Nine home visit caregivers completed surveys at baseline AND visit 4/twelve months; ten usual care caregivers completed surveys at baseline and twelve months. The remainder of participants did not have caregivers available at the time of home visit or survey completion, respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Visit Arm | Change in Caregiver Strain as Measured by the Multidimensional Caregiver Strain Index (MCSI) Between Baseline (Visit 1) and 1 Year (Visit 4) | 0.44 score on a scale | Standard Deviation 5.77 |
| Usual Care Arm (NOT RANDOMIZED) | Change in Caregiver Strain as Measured by the Multidimensional Caregiver Strain Index (MCSI) Between Baseline (Visit 1) and 1 Year (Visit 4) | 2.3 score on a scale | Standard Deviation 9.46 |
p-value: 0.62t-test, 2 sided
Other Pre-specified
Caregiver Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF)
A 9-item instrument developed within the field of social work to assess client satisfaction with multidisciplinary programs like the home visit program in this study. Each item is scored on a 1-7 scale, for a total possible raw score of 7-63, scaled to 0-100% of the possible score, with higher scores indicating greater client satisfaction. This measure will be completed at our last home visit (Visit 4).
Time frame: 1 year
Population: 10 caregivers completed the surveys at visit 4
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Home Visit Arm | Caregiver Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF) | 98 score on a scale |
Other Pre-specified
Patient Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF)
A 9-item instrument developed within the field of social work to assess client satisfaction with multidisciplinary programs like the home visit program in this study. Each item is scored on a 1-7 scale, for a total possible raw score of 7-63, scaled to 0-100% of the possible score, with higher scores indicating greater client satisfaction. This measure will be completed at our last home visit (Visit 4).
Time frame: 1 year
Population: 14 patients completed visit 4
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Home Visit Arm | Patient Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF) | 100 score on a scale |