In-Home Care for Patients With PSP and Related Disorders

NCT03552484 | Completed Results

• 2 other identifiers: 17101005633-2016-10
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Change in Caregiver Strain as Measured by the Multidimensional Caregiver Strain Index (MCSI) Between Baseline (Visit 1) and 1 Year (Visit 4)

  1 year

Other Outcomes (2)

• Patient Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF)

  1 year

• Caregiver Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF)

  1 year

Study Arms (2)

Home Visit Arm

ACTIVE COMPARATOR

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. \[Completion of Home Visit Program\]

Behavioral: Home Visit Program

Usual Care Arm

ACTIVE COMPARATOR

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. \[Completion of Usual Care/Online Survey\]

Behavioral: Usual Care/Online Survey

Interventions

Home Visit Program BEHAVIORAL

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

Home Visit Arm

Usual Care/Online Survey BEHAVIORAL

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.

Usual Care Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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

You may not qualify if:

• Diagnosis of idiopathic Parkinson's Disease
• Diagnosis of another neurodegenerative disease
• Subjects with active psychosis or exhibiting symptoms of a severe psychiatric disorder

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive; Lewy Body Disease; Multiple System Atrophy; Corticobasal Degeneration; Parkinson Disease, Familial, Type 1

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Dementia; Synucleinopathies; Neurocognitive Disorders; Mental Disorders; Primary Dysautonomias; Autonomic Nervous System Diseases

Limitations and Caveats

This was not a randomized trial and the "usual care"/control group was poorly defined and suffered from significant loss to follow-up. The usual care group was recruited via online survey and completed a battery of online surveys at baseline. One year later, the usual care participants received up to five emails at the email address initially provided upon enrollment. There was significant loss to follow-up with lack of response to emailed reminders.

Results Point of Contact

• Title: Jori Fleisher, MD MSCE
• Organization: Rush University Medical Center

jori_fleisher@rush.edu

3125632900

Study Officials

• Jori Fleisher, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: June 11, 2018
• Study Start: May 30, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 1, 2024
• Results First Posted: April 1, 2024

Record last verified: 2023-10

Locations

US (1)