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| ID | Type | Description | Link |
|---|---|---|---|
| 633-2016-10 | Other Grant/Funding Number | CurePSP |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Visit Arm | Active Comparator | Participants and their caregivers, when available, 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] |
|
| Usual Care Arm | Active Comparator | Participants and their caregivers, when available, will be asked to complete an initial online survey. Twelve months later, patients (and caregivers, if available) will be asked to complete an online follow-up survey. [Completion of Usual Care/Online Survey] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Visit Program | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Additional Inclusion Criteria For the Home Care Arm:
Additional Inclusion Criteria For the Usual Care Arm:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jori Fleisher, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 In the event that a patient is unable to answer the survey questions on their own but has a knowledgeable caregiver who can answer on their behalf, the caregiver can complete the survey as the patient's proxy, answering questions AS the patient. All counts include PATIENTS only |
| FG001 | Usual Care Arm (NOT RANDOMIZED) | Patients 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. In the event that a patient is unable to answer the survey questions on their own but has a knowledgeable caregiver who can answer on their behalf, the caregiver can complete the survey as the patient's proxy, answering questions AS the patient. All counts include PATIENTS only |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Two participants in the usual care arm signed the informed consent but did not complete any surveys, including demographic information, explaining the difference between the 36 in the protocol and participant flow modules, and 34 here.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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. | 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. | Posted | Median | Full Range | units on a scale | 1 year |
|
1 year
Survey data
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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This was not a randomized trial and the "usual care"/control group was poorly defined and suffered from significant loss to follow-up. The usual care group was recruited via online survey and completed a battery of online surveys at baseline. One year later, the usual care participants received up to five emails at the email address initially provided upon enrollment. There was significant loss to follow-up with lack of response to emailed reminders.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jori Fleisher, MD MSCE | Rush University Medical Center | 3125632900 | jori_fleisher@rush.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2019 | Oct 10, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 18, 2019 | Oct 10, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013494 | Supranuclear Palsy, Progressive |
| D020961 | Lewy Body Disease |
| D019578 | Multiple System Atrophy |
| D000088282 | Corticobasal Degeneration |
| C566823 | Parkinson Disease, Familial, Type 1 |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Usual Care/Online Survey | Behavioral | 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. |
|
| 1 year |
| 1 year |
| 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). | 1 year |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | 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 |
|
| Diagnosis | Count of Participants | Participants |
|
| Self-reported homebound status | Meets Centers for Medicare and Medicaid services definition of homebound, namely, 1) requires a considerable and taxing effort to leave the home due to medical condition, and 2) requires EITHER an assistive device, assistive transportation, or a care partner or other accompanying individual to assist with leaving the home | Count of Participants | Participants |
|
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
| OG001 | 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. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
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|
|
| 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). | 14 patients completed visit 4 | Posted | Median | Inter-Quartile Range | score on a scale | 1 year |
|
|
|
| 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). | 10 caregivers completed the surveys at visit 4 | Posted | Median | Inter-Quartile Range | score on a scale | 1 year |
|
|
|
| 6 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 4 | 36 | 0 | 36 | 0 | 36 |
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| D009069 | Movement Disorders |
| D009886 | Ophthalmoplegia |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020734 | Parkinsonian Disorders |
| D003704 | Dementia |
| D000080874 | Synucleinopathies |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |