In-Home Care for Patients With PSP and Related Disorders

• ClinicalTrials.gov Identifier: NCT03552484
• Recruitment Status: Completed
• First Posted: June 11, 2018
• Last Update Posted: May 4, 2021
• Sponsor: Rush University Medical Center
• Information provided by (Responsible Party): Rush University Medical Center

Tracking Information

• First Submitted Date: April 16, 2018
• First Posted Date: June 11, 2018
• Last Update Posted Date: May 4, 2021
• Actual Study Start Date: May 30, 2018
• Actual Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 29, 2018)

• Change in patient quality of life as measured by the EuroQol 5-D (EQ-5D) scale [ Time Frame: 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 caregiver quality of life as measured by the EuroQol 5-D (EQ-5D) scale [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 29, 2018)

Change in caregiver strain as measured by the Multidimensional Caregiver Strain Index (MCSI) [ Time Frame: 1 year ]

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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: May 29, 2018)

• Patient satisfaction with the home visit program as measured by the Client Satisfaction Inventory- Short Form (CSI-SF) [ Time Frame: 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, 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) [ Time Frame: 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, with higher scores indicating greater client satisfaction. This measure will be completed at our last home visit (Visit 4).

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

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

Intervention

• Behavioral: 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
• Behavioral: Usual 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.

Study Arms

• Active Comparator: Home Visit Arm

  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]

  Intervention: Behavioral: Home Visit Program
• Active Comparator: Usual Care Arm

  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]

  Intervention: Behavioral: Usual Care/Online Survey

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 22, 2020): 71
• Original Estimated Enrollment (submitted: May 29, 2018): 80
• Actual Study Completion Date: December 31, 2020
• Actual Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03552484
• Other Study ID Numbers: 17101005; 633-2016-10 ( Other Grant/Funding Number: CurePSP )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Rush University Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Rush University Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jori Fleisher, MD; Rush University Medical Center

• PRS Account: Rush University Medical Center
• Verification Date: May 2021