Trial Outcomes & Findings for In-Home Care for Patients With PSP and Related Disorders (NCT NCT03552484)
NCT ID: NCT03552484
Last Updated: 2024-04-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
1 year
Results posted on
2024-04-01
Participant Flow
Participant milestones
| Measure |
Home Visit Arm
Participants 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.
\[Completion of Home Visit Program\]
Home Visit Program: 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
In the event that a patient is unable to answer the survey questions on their own but has a knowledgeable caregiver who can answer on their behalf, the caregiver can complete the survey as the patient's proxy, answering questions AS the patient.
All counts include PATIENTS only
|
Usual Care Arm (NOT RANDOMIZED)
Patients will be asked to complete an initial online survey. Twelve months later, patients will be asked to complete an online follow-up survey.
\[Completion of Usual Care/Online Survey\]
Usual Care/Online Survey: Patients 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.
In the event that a patient is unable to answer the survey questions on their own but has a knowledgeable caregiver who can answer on their behalf, the caregiver can complete the survey as the patient's proxy, answering questions AS the patient.
All counts include PATIENTS only
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
36
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
20
|
Reasons for withdrawal
| Measure |
Home Visit Arm
Participants 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.
\[Completion of Home Visit Program\]
Home Visit Program: 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
In the event that a patient is unable to answer the survey questions on their own but has a knowledgeable caregiver who can answer on their behalf, the caregiver can complete the survey as the patient's proxy, answering questions AS the patient.
All counts include PATIENTS only
|
Usual Care Arm (NOT RANDOMIZED)
Patients will be asked to complete an initial online survey. Twelve months later, patients will be asked to complete an online follow-up survey.
\[Completion of Usual Care/Online Survey\]
Usual Care/Online Survey: Patients 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.
In the event that a patient is unable to answer the survey questions on their own but has a knowledgeable caregiver who can answer on their behalf, the caregiver can complete the survey as the patient's proxy, answering questions AS the patient.
All counts include PATIENTS only
|
|---|---|---|
|
Overall Study
Death
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
16
|
Baseline Characteristics
In-Home Care for Patients With PSP and Related Disorders
Baseline characteristics by cohort
| Measure |
Home Visit Arm
n=20 Participants
Participants 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.
\[Completion of Home Visit Program\]
Home Visit Program: 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 Arm (NOT RANDOMIZED)
n=34 Participants
Participants will be asked to complete an initial online survey. Twelve months later, patients will be asked to complete an online follow-up survey.
\[Completion of Usual Care/Online Survey\]
Usual Care/Online Survey: Patients 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.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Continuous
|
73.2 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
71.7 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
72.3 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
34 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Diagnosis
Progressive Supranuclear Palsy
|
8 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Diagnosis
Multiple System Atrophy
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Diagnosis
Corticobasal Syndrome
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Diagnosis
Atypical parkinsonism
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Self-reported homebound status
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: In the home visit arm, six patients died between visits 1 and 4, yielding a cohort of 14 patients available to complete surveys at visit 4. In the usual care arm, only sixteen participants responded to at least one survey at month 12; the remainder were lost to follow-up despite multiple attempts to reach them via email over a period of weeks.
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.
Outcome measures
| Measure |
Home Visit Arm
n=14 Participants
Participants 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.
\[Completion of Home Visit Program\]
Home Visit Program: 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 Arm (NOT RANDOMIZED)
n=16 Participants
Participants will be asked to complete an initial online survey. Twelve months later, patients will be asked to complete an online follow-up survey.
\[Completion of Usual Care/Online Survey\]
Usual Care/Online Survey: Patients 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)
Mobility
|
1 units on a scale
Interval 0.0 to 2.0
|
0.5 units on a scale
Interval 0.0 to 1.0
|
|
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)
Self-care
|
0.5 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval -1.0 to 3.0
|
|
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)
Activities of daily living
|
1 units on a scale
Interval 0.0 to 3.0
|
0 units on a scale
Interval -1.0 to 2.0
|
|
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)
Anxiety/depression
|
0 units on a scale
Interval -1.0 to 2.0
|
0 units on a scale
Interval -1.0 to 2.0
|
|
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)
Pain/discomfort
|
0 units on a scale
Interval -3.0 to 4.0
|
0 units on a scale
Interval -2.0 to 1.0
|
PRIMARY outcome
Timeframe: 1 yearPopulation: In the home visit arm, six patients died between visits 1 and 4, yielding a cohort of 14 patients available to complete surveys at visit 4. Five of the 14 did not complete the visual analog scale. In the usual care arm, only sixteen participants responded to at least one survey at month 12, however six of the 16 did not complete the visual analog scale; the remainder were lost to follow-up despite multiple attempts to reach them via email over a period of weeks.
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.
Outcome measures
| Measure |
Home Visit Arm
n=9 Participants
Participants 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.
\[Completion of Home Visit Program\]
Home Visit Program: 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 Arm (NOT RANDOMIZED)
n=10 Participants
Participants will be asked to complete an initial online survey. Twelve months later, patients will be asked to complete an online follow-up survey.
\[Completion of Usual Care/Online Survey\]
Usual Care/Online Survey: Patients 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 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 score on a scale
Standard Deviation 38.85
|
4.81 score on a scale
Standard Deviation 23.82
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Nine home visit caregivers completed surveys at baseline AND visit 4/twelve months; ten usual care caregivers completed surveys at baseline and twelve months. The remainder of participants did not have caregivers available at the time of home visit or survey completion, respectively.
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.
Outcome measures
| Measure |
Home Visit Arm
n=9 Participants
Participants 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.
\[Completion of Home Visit Program\]
Home Visit Program: 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 Arm (NOT RANDOMIZED)
n=10 Participants
Participants will be asked to complete an initial online survey. Twelve months later, patients will be asked to complete an online follow-up survey.
\[Completion of Usual Care/Online Survey\]
Usual Care/Online Survey: Patients 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 Caregiver Strain as Measured by the Multidimensional Caregiver Strain Index (MCSI) Between Baseline (Visit 1) and 1 Year (Visit 4)
|
0.44 score on a scale
Standard Deviation 5.77
|
2.3 score on a scale
Standard Deviation 9.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: 14 patients completed visit 4
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).
Outcome measures
| Measure |
Home Visit Arm
n=14 Participants
Participants 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.
\[Completion of Home Visit Program\]
Home Visit Program: 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 Arm (NOT RANDOMIZED)
Participants will be asked to complete an initial online survey. Twelve months later, patients will be asked to complete an online follow-up survey.
\[Completion of Usual Care/Online Survey\]
Usual Care/Online Survey: Patients 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.
|
|---|---|---|
|
Patient Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF)
|
100 score on a scale
Interval 77.8 to 100.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: 10 caregivers completed the surveys at visit 4
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).
Outcome measures
| Measure |
Home Visit Arm
n=10 Participants
Participants 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.
\[Completion of Home Visit Program\]
Home Visit Program: 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 Arm (NOT RANDOMIZED)
Participants will be asked to complete an initial online survey. Twelve months later, patients will be asked to complete an online follow-up survey.
\[Completion of Usual Care/Online Survey\]
Usual Care/Online Survey: Patients 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.
|
|---|---|---|
|
Caregiver Satisfaction With the Home Visit Program as Measured by the Client Satisfaction Inventory- Short Form (CSI-SF)
|
98 score on a scale
Interval 87.0 to 100.0
|
—
|
Adverse Events
Home Visit Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths
Usual Care Arm (NOT RANDOMIZED)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place