40 and older, any sex, with Progressive Supranuclear Palsy or Dementia With Lewy Bodies. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)Primary· 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.
Mobility
Group
Value
95% CI
Home Visit Arm
1
0 – 2
Usual Care Arm (NOT RANDOMIZED)
0.5
0 – 1
Self-care
Group
Value
95% CI
Home Visit Arm
0.5
0 – 2
Usual Care Arm (NOT RANDOMIZED)
0
-1 – 3
Activities of daily living
Group
Value
95% CI
Home Visit Arm
1
0 – 3
Usual Care Arm (NOT RANDOMIZED)
0
-1 – 2
Anxiety/depression
Group
Value
95% CI
Home Visit Arm
0
-1 – 2
Usual Care Arm (NOT RANDOMIZED)
0
-1 – 2
Pain/discomfort
Group
Value
95% CI
Home Visit Arm
0
-3 – 4
Usual Care Arm (NOT RANDOMIZED)
0
-2 – 1
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)Primary· 1 year
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.
Group
Value
95% CI
Home Visit Arm
-1.43
± 38.85
Usual Care Arm (NOT RANDOMIZED)
4.81
± 23.82
Change in Caregiver Strain as Measured by the Multidimensional Caregiver Strain Index (MCSI) Between Baseline (Visit 1) and 1 Year (Visit 4)Secondary· 1 year
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.
Group
Value
95% CI
Home Visit Arm
0.44
± 5.77
Usual Care Arm (NOT RANDOMIZED)
2.3
± 9.46
Patient Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF)Secondary· 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, 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).
Group
Value
95% CI
Home Visit Participants - Patients
100
77.8 – 100
Caregiver Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF)Secondary· 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, 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).
Group
Value
95% CI
Home Visit Participants - Caregivers
98
87.0 – 100
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rush University Medical Center
Last refreshed: 1 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03552484.