In-Home Care for Patients With PSP and Related Disorders

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Brief Title

In-Home Care for Patients With PSP and Related Disorders

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

Change in patient quality of life as measured by the EuroQol 5-D (EQ-5D) scale

Secondary Outcome

 Change in caregiver strain as measured by the Multidimensional Caregiver Strain Index (MCSI)

Condition

Progressive Supranuclear Palsy

Intervention

Home Visit Program

Study Arms / Comparison Groups

 Home Visit Arm
Description:  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]

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

71

Start Date

May 30, 2018

Completion Date

December 31, 2020

Primary Completion Date

December 31, 2020

Eligibility Criteria

        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
      

Gender

All

Ages

40 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jori Fleisher, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03552484

Organization ID

17101005

Secondary IDs

633-2016-10

Responsible Party

Sponsor

Study Sponsor

Rush University Medical Center


Study Sponsor

Jori Fleisher, MD, Principal Investigator, Rush University Medical Center


Verification Date

May 2021