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In-Home Care for Patients With PSP and Related Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552484
Recruitment Status : Active, not recruiting
First Posted : June 11, 2018
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE April 16, 2018
First Posted Date  ICMJE June 11, 2018
Last Update Posted Date January 23, 2020
Actual Study Start Date  ICMJE May 30, 2018
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE In-Home Care for Patients With PSP and Related Disorders
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Progressive Supranuclear Palsy
  • Dementia With Lewy Bodies
  • Multiple System Atrophy
  • Corticobasal Syndrome
  • Atypical Parkinson Disease
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 22, 2020)
71
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2018)
80
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03552484
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jori Fleisher, MD Rush University Medical Center
PRS Account Rush University Medical Center
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP