Back to resultsIn-Home Care for Patients With PSP and Related Disorders
Primary Purpose
Progressive Supranuclear Palsy, Dementia With Lewy Bodies, Multiple System Atrophy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Visit Program
Usual Care/Online Survey
Sponsored by
About this trial
This is an interventional supportive care trial for Progressive Supranuclear Palsy
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
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Home Visit Arm
Usual Care Arm
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]
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]
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03552484
First Posted
April 16, 2018
Last Updated
May 3, 2021
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03552484
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Supranuclear Palsy, Dementia With Lewy Bodies, Multiple System Atrophy, Corticobasal Syndrome, Atypical Parkinson Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home Visit Arm
Arm Type
Active Comparator
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]
Arm Title
Usual Care Arm
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Home Visit Program
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Usual Care/Online Survey
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in patient quality of life as measured by the EuroQol 5-D (EQ-5D) scale
Description
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.
Time Frame
1 year
Title
Change in caregiver quality of life as measured by the EuroQol 5-D (EQ-5D) scale
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in caregiver strain as measured by the Multidimensional Caregiver Strain Index (MCSI)
Description
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.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Patient satisfaction with the home visit program as measured by the Client Satisfaction Inventory- Short Form (CSI-SF)
Description
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).
Time Frame
1 year
Title
Caregiver satisfaction with the home visit program as measured by the Client Satisfaction Inventory- Short Form (CSI-SF)
Description
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).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jori Fleisher, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
In-Home Care for Patients With PSP and Related Disorders
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