In-Home Care for Patients With PSP and Related Disorders

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CarePSP: Care Where It Counts - Interdisciplinary Home Visits for PSP-Related Disorders

Conditions
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Progressive Supranuclear Palsy, Dementia With Lewy Bodies, Multiple System Atrophy, Corticobasal Syndrome, Atypical Parkinson Disease

Intervention / Treatment
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* Behavioral: Home Visit Program
* Behavioral: Usual Care/Online Survey


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Home Visit Arm<br>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] | Behavioral: Home Visit Program<br>* 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<br>|
| Active Comparator: Usual Care Arm<br>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] | Behavioral: Usual Care/Online Survey<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient quality of life as measured by the EuroQol 5-D (EQ-5D) scale | 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 caregiver quality of life as measured by the EuroQol 5-D (EQ-5D) scale | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in caregiver strain as measured by the Multidimensional Caregiver Strain Index (MCSI) | An 18-item tool measuring 6 dimensions of subjective response to stressors. Subscales include physical strain, social constraints, financial strain, time constraints, interpersonal strain, and elder being demanding/manipulative. Respondents are asked about the frequency with which items apply, ranging from never to all of the time on a 5 point scale. Higher scores indicate higher levels of caregiver strain. Scores at Visits 1-4 will be compared. | 1 year |