An interventional study of Home Visit Program and Usual Care/Online Survey in Progressive Supranuclear Palsy, Dementia With Lewy Bodies and Multiple System Atrophy, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-01.
Sponsored by Rush University Medical Center · Not applicable, Interventional, and Supportive care
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.
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.
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This study's enrollment of 56 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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Additional Inclusion Criteria For the Home Care Arm:
Additional Inclusion Criteria For the Usual Care Arm:
Exclusion Criteria:
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
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
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
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.
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.
Time frame: 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.
Time frame: 1 year
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.
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
| Milestone | Home Visit Arm | Usual Care Arm (NOT RANDOMIZED) |
|---|---|---|
| Started | 20 | 36 |
| Completed | 14 | 16 |
| Not completed | 6 | 20 |
| Withdrew: Death | 6 | 4 |
| Withdrew: Lost to follow-up | 0 | 16 |
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.
| units on a scale | Home Visit Arm | Usual Care Arm (NOT RANDOMIZED) |
|---|---|---|
| Mobility | 1 (0 to 2) | 0.5 (0 to 1) |
| Self-care | 0.5 (0 to 2) | 0 (-1 to 3) |
| Activities of daily living | 1 (0 to 3) | 0 (-1 to 2) |
| Anxiety/depression | 0 (-1 to 2) | 0 (-1 to 2) |
| Pain/discomfort | 0 (-3 to 4) | 0 (-2 to 1) |
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.
| score on a scale | Home Visit Arm | Usual Care Arm (NOT RANDOMIZED) |
|---|---|---|
| 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 ± 38.85 | 4.81 ± 23.82 |
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.
| score on a scale | Home Visit Arm | Usual Care Arm (NOT RANDOMIZED) |
|---|---|---|
| Change in Caregiver Strain as Measured by the Multidimensional Caregiver Strain Index (MCSI) Between Baseline (Visit 1) and 1 Year (Visit 4) | 0.44 ± 5.77 | 2.3 ± 9.46 |
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).
| score on a scale | Home Visit Participants - Patients |
|---|---|
| Patient Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF) | 100 (77.8 to 100) |
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).
| score on a scale | Home Visit Participants - Caregivers |
|---|---|
| Caregiver Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF) | 98 (87.0 to 100) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Home Visit Arm | 6/20 (30%) | 0/20 (0%) | 0/20 (0%) |
| Usual Care Arm (NOT RANDOMIZED) | 4/36 (11.1%) | 0/36 (0%) | 0/36 (0%) |
Two participants in the usual care arm signed the informed consent but did not complete any surveys, including demographic information, explaining the difference between the 36 in the protocol and participant flow modules, and 34 here.
| Age, Categorical(Participants) | Home Visit Arm | Usual Care Arm (NOT RANDOMIZED) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 6 | 9 |
| >=65 years | 17 | 28 | 45 |
| Age, Continuous(years) | Home Visit Arm | Usual Care Arm (NOT RANDOMIZED) | Total |
|---|---|---|---|
| Mean | 73.2 ± 8.1 | 71.7 ± 7.7 | 72.3 ± 7.8 |
| Sex: Female, Male(Participants) | Home Visit Arm | Usual Care Arm (NOT RANDOMIZED) | Total |
|---|---|---|---|
| Female | 13 | 15 | 28 |
| Male | 7 | 19 | 26 |
| Ethnicity (NIH/OMB)(Participants) | Home Visit Arm | Usual Care Arm (NOT RANDOMIZED) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 20 | 30 | 50 |
| Unknown or Not Reported | 0 | 3 | 3 |
| Race (NIH/OMB)(Participants) | Home Visit Arm | Usual Care Arm (NOT RANDOMIZED) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 |
| White | 17 | 33 | 50 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Home Visit Arm | Usual Care Arm (NOT RANDOMIZED) | Total |
|---|---|---|---|
| United States | 20 | 34 | 54 |
| Diagnosis(Participants) | Home Visit Arm | Usual Care Arm (NOT RANDOMIZED) | Total |
|---|---|---|---|
| Progressive Supranuclear Palsy | 8 | 23 | 31 |
| Multiple System Atrophy | 7 | 5 | 12 |
| Corticobasal Syndrome | 3 | 2 | 5 |
| Atypical parkinsonism | 2 | 4 | 6 |
| Self-reported homebound status(Participants) | Home Visit Arm | Usual Care Arm (NOT RANDOMIZED) | Total |
|---|---|---|---|
| Count of participants | 20 | 29 | 49 |
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