In-Home Care for Patients With PSP and Related Disorders

Multiple System Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552484
• Other study ID #: 17101005
• Secondary ID: 633-2016-10
• Status: Completed
• Phase: N/A
• Start date: May 30, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atypical Parkinson Disease
• Corticobasal Degeneration
• Corticobasal Syndrome
• Dementia With Lewy Bodies
• Lewy Body Disease
• Multiple System Atrophy
• Parkinson Disease
• Progressive Supranuclear Palsy
• Shy-Drager Syndrome
• Supranuclear Palsy, Progressive

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
• 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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF)	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, for a total possible raw score of 7-63, scaled to 0-100% of the possible score, with higher scores indicating greater client satisfaction. This measure will be completed at our last home visit (Visit 4).	1 year
Other	Caregiver Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF)	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, for a total possible raw score of 7-63, scaled to 0-100% of the possible score, with higher scores indicating greater client satisfaction. This measure will be completed at our last home visit (Visit 4).	1 year
Primary	Change in Patient Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Between Baseline (Visit 1) and 1 Year (Visit 4)	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
Primary	Change in Overall Quality of Life as Measured by the EuroQol 5-D (EQ-5D) Scale Visual Analog Scale Item Between Baseline (Visit 1) and 1 Year (Visit 4)	This item is a 0-100 point visual analog scale for rating overall quality of life where 0 is "the worst" and 100 "the best health you can imagine". Scores at Visits 1 and 4 will be compared.	1 year
Secondary	Change in Caregiver Strain as Measured by the Multidimensional Caregiver Strain Index (MCSI) Between Baseline (Visit 1) and 1 Year (Visit 4)	An 18-item tool measuring subjective response to stressors. Respondents are asked about the frequency with which items apply, ranging from "never" to "all of the time" on a 5 point scale. The range is from 0 to 72, where higher scores indicate higher levels of caregiver strain, and scores in the 20-29 range are categorized as "moderate" strain, and scores 30 or higher are categorized as severe strain. Scores at Visits 1-4 will be compared.	1 year