N/A
N=56
In-Home Care for Patients With PSP and Related Disorders
Progressive Supranuclear Palsy · Dementia With Lewy Bodies · Multiple System Atrophy · Corticobasal Syndrome · Atypical Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT03552484 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: 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) — 1; 0.5; 0.5; 0 units on a scale — p=0.59
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home Visit Program (Behavioral); Usual Care/Online Survey (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
1; 0.5; 0.5; 0; 1; 0 | 0.59 |
| 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) |
-1.43; 4.81 | 0.59 |
| SECONDARY Change in Caregiver Strain as Measured by the Multidimensional Caregiver Strain Index (MCSI) Between Baseline (Visit 1) and 1 Year (Visit 4) |
0.44; 2.3 | 0.62 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03552484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.