Progressive Supranuclear PalsyNCT03552484
In-Home Care for Patients With PSP and Related Disorders
A study testing Home Visit Program in people with Progressive Supranuclear Palsy and Dementia With Lewy Bodies, run by Rush University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Progressive Supranuclear Palsy, Dementia With Lewy Bodies, Multiple System Atrophy
- What is being tested?
- Home Visit Program
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- Diagnosis of idiopathic Parkinson's Disease
- Diagnosis of another neurodegenerative disease
- Subjects with active psychosis or exhibiting symptoms of a severe psychiatric disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: CarePSP: Care Where It Counts - Interdisciplinary Home Visits for PSP-Related Disorders
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.
Read the detailed 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.
- Conditions
- Progressive Supranuclear Palsy, Dementia With Lewy Bodies, Multiple System Atrophy, Corticobasal Syndrome, Atypical Parkinson Disease
- Being tested
- Home Visit Program, Usual Care/Online Survey
- Medical subject headings
- Supranuclear Palsy, Progressive, Lewy Body Disease, Multiple System Atrophy, Corticobasal Degeneration, Parkinson Disease, Familial, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Visit ProgramBehavioural
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 SurveyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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] Receives: 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] Receives: Behavioral: Usual Care/Online Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start30 May 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jori Fleisher, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552484
- Sponsor's protocol ID
- 17101005
- Other IDs
- 633-2016-10
- Status last verified
- Oct 2023
- First submitted
- 16 Apr 2018
- Last updated
- 1 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CarePSP: Care Where It Counts - Interdisciplinary Home Visits for PSP-Related Disorders
- ClinicalTrials.gov ID
- NCT03552484
- Acronym / sponsor ID
- 17101005
- Conditions
- Progressive Supranuclear Palsy, Dementia With Lewy Bodies, Multiple System Atrophy, Corticobasal Syndrome, Atypical Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Posted 1 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Visit Arm | Active comparator | Behavioral: Home Visit ProgramParticipants 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] |
| Usual Care Arm | Active comparator | Behavioral: Usual Care/Online SurveyParticipants 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] |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (3 listed)
- Diagnosis of idiopathic Parkinson's Disease
- Diagnosis of another neurodegenerative disease
- Subjects with active psychosis or exhibiting symptoms of a severe psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Visit ProgramInformed 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 | Behavioural | Home Visit Arm |
| Usual Care/Online SurveyPatients 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. | Behavioural | Usual Care Arm |
Primary outcome
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)
Time frame: 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.
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)
Time frame: 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.
1 secondary outcome
Change in Caregiver Strain as Measured by the Multidimensional Caregiver Strain Index (MCSI) Between Baseline (Visit 1) and 1 Year (Visit 4)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jori Fleisher, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Visit Program in people with Progressive Supranuclear Palsy and Dementia With Lewy Bodies, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.