Trial Outcomes & Findings for Dementia Symptom Management at Home Program (NCT NCT03255967)
NCT ID: NCT03255967
Last Updated: 2024-01-30
Results Overview
13-item measurement of Alzheimer's disease patients' health-related quality of life (HRQOL) by proxy (caregiver) assessment. Each item is rated on a 4-point Likert scale ranging from 1 (poor) to 4 (excellent). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate greater HRQOL. An increase in scores indicates HRQOL increased during the observational period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
217 participants
Primary outcome timeframe
Baseline, Day 60
Results posted on
2024-01-30
Participant Flow
The trial enrolled 215 Patient-Caregiver Dyads (215 patients with dementia (PWD) and 215 caregivers). 119 Dyads were randomized to the QI program care arm and 96 Dyads were randomized to the Control arm.
Participant milestones
| Measure |
QI Program Care
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Overall Study
STARTED
|
238
|
192
|
|
Overall Study
Number of Patients Started
|
119
|
96
|
|
Overall Study
Number of Patients Completed
|
99
|
76
|
|
Overall Study
Number of Caregivers Started
|
119
|
96
|
|
Overall Study
Number of Caregivers Completed
|
99
|
76
|
|
Overall Study
COMPLETED
|
198
|
152
|
|
Overall Study
NOT COMPLETED
|
40
|
40
|
Reasons for withdrawal
| Measure |
QI Program Care
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Overall Study
Adverse Event
|
26
|
30
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Schedule conflict
|
6
|
4
|
|
Overall Study
POA did not sign consent form
|
2
|
0
|
Baseline Characteristics
Dementia Symptom Management at Home Program
Baseline characteristics by cohort
| Measure |
QI Program Care - PWD
n=119 Participants
Patients with dementia (PWD) assigned to the QI program care arm as part of a Patient-Caregiver dyad.
|
QI Program Care - Caregiver
n=119 Participants
Caregivers assigned to the QI program care arm as part of a Patient-Caregiver dyad.
|
Control - PWD
n=96 Participants
Patients with dementia (PWD) assigned to the control arm as part of a Patient-Caregiver dyad.
|
Control - Caregiver
n=96 Participants
Caregivers assigned to the control arm as part of a Patient-Caregiver dyad.
|
Total
n=430 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
83 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
63 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
84 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
57 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
71.75 years
STANDARD_DEVIATION 7.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
302 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
375 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
124 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
271 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
119 participants
n=5 Participants
|
119 participants
n=7 Participants
|
96 participants
n=5 Participants
|
96 participants
n=4 Participants
|
430 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 6013-item measurement of Alzheimer's disease patients' health-related quality of life (HRQOL) by proxy (caregiver) assessment. Each item is rated on a 4-point Likert scale ranging from 1 (poor) to 4 (excellent). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate greater HRQOL. An increase in scores indicates HRQOL increased during the observational period.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Quality of Life-Alzheimer's Disease Score
|
12.32 score on a scale
Standard Deviation 16.69
|
15.88 score on a scale
Standard Deviation 22.77
|
PRIMARY outcome
Timeframe: Baseline, Day 60The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the IADL scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to assistance with IADLs improved during the observational period.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Caregiver-Targeted Quality of Life Measure Score - IADL Scale
|
12.32 score on a scale
Standard Deviation 16.69
|
15.88 score on a scale
Standard Deviation 22.77
|
PRIMARY outcome
Timeframe: Baseline, Day 60The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the ADL scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to assistance with ADLs improved during the observational period.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Caregiver-Targeted Quality of Life Measure Score - ADL Scale
|
47.45 score on a scale
Standard Deviation 37.45
|
44.94 score on a scale
Standard Deviation 37.26
|
PRIMARY outcome
Timeframe: Baseline, Day 60The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the role limitations scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to role limitation due to caregiving improved during the observational period.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Caregiver-Targeted Quality of Life Measure Score - Role Limitations Scale
|
46.33 score on a scale
Standard Deviation 28.96
|
46.56 score on a scale
Standard Deviation 26.76
|
PRIMARY outcome
Timeframe: Baseline, Day 60The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the personal time scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to personal care improved during the observational period.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Caregiver-Targeted Quality of Life Measure Score - Personal Time Scale
|
38.71 score on a scale
Standard Deviation 22.12
|
40.34 score on a scale
Standard Deviation 19.67
|
PRIMARY outcome
Timeframe: Baseline, Day 60The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the family interaction scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to family interaction improved during the observational period.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Caregiver-Targeted Quality of Life Measure Score - Family Interaction Scale
|
53.27 score on a scale
Standard Deviation 28.45
|
52.11 score on a scale
Standard Deviation 28.42
|
PRIMARY outcome
Timeframe: Baseline, Day 60The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the demands of caregiving scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to demands of caregiving improved during the observational period.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Caregiver-Targeted Quality of Life Measure Score - Demands of Caregiving Scale
|
56.6 score on a scale
Standard Deviation 24.39
|
56.22 score on a scale
Standard Deviation 25.35
|
PRIMARY outcome
Timeframe: Baseline, Day 60The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the worry scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to worry improved during the observational period.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Caregiver-Targeted Quality of Life Measure Score - Worry Scale
|
51.25 score on a scale
Standard Deviation 21.7
|
52.56 score on a scale
Standard Deviation 19.89
|
PRIMARY outcome
Timeframe: Baseline, Day 60The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the spirituality scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to spirituality improved during the observational period.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Caregiver-Targeted Quality of Life Measure Score - Spirituality Scale
|
79.25 score on a scale
Standard Deviation 29.1
|
67.75 score on a scale
Standard Deviation 33.94
|
PRIMARY outcome
Timeframe: Baseline, Day 60The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the benefits of caregiving scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to benefits of caregiving improved during the observational period.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Caregiver-Targeted Quality of Life Measure Score - Benefits of Caregiving Scale
|
81.38 score on a scale
Standard Deviation 20.18
|
79.34 score on a scale
Standard Deviation 20.64
|
PRIMARY outcome
Timeframe: Baseline, Day 60The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the caregiver feelings scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to caregiver feelings improved during the observational period.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Caregiver-Targeted Quality of Life Measure Score - Caregiver Feelings Scale
|
72.53 score on a scale
Standard Deviation 16.82
|
76.49 score on a scale
Standard Deviation 13.73
|
PRIMARY outcome
Timeframe: Up to Day 60Measured through interviews with the informal caregiver using the Resource Utilization Inventory.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Number of Emergency Room (ER) Visits by Patients With Dementia (PWD) During Study Period
|
0.08 ER visits
Standard Deviation 0.34
|
0.08 ER visits
Standard Deviation 0.31
|
PRIMARY outcome
Timeframe: Up to Day 60Measured through interviews with the informal caregiver using the Resource Utilization Inventory.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Number of PWD Inpatient Admissions During Study Period
|
0.08 Hospitalizations
Standard Deviation 0.4
|
0.13 Hospitalizations
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: Baseline, Day 605-item assessment of pain in individuals with advanced dementia. Items are ranked on a 3-point Likert scale from 0 to 2. The total score is the sum of responses and ranges from 0 (no pain) to 10 (severe pain). An increase in scores indicates pain increased during the observational period.
Outcome measures
| Measure |
QI Program Care
n=107 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=85 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Pain Assessment In Advanced Dementia (PAINAD) Score
|
0.14 score on a scale
Standard Deviation 0.62
|
0.05 score on a scale
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Baseline, Day 6013-item tool that measures caregiver perceptions of Behavioral and Psychological Symptoms of Dementia (BPSD). For each item, The severity of the reported symptoms is assessed on a 3-point scale. The total severity score ranges from 0 to 36 with higher scores representing worse severity. An increase in score indicates severity of BPSD increased during the observational period.
Outcome measures
| Measure |
QI Program Care
n=117 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score
|
8.45 score on a scale
Standard Deviation 6.31
|
7.96 score on a scale
Standard Deviation 5.78
|
SECONDARY outcome
Timeframe: Up to Day 60Measured via patient medication record.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Number of PWD Who Use Antipsychotics During Study Period
|
20 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to Day 60Measured via patient medication record.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Number of PWD Who Use Analgesics During Study Period
|
45 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Up to Day 60Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Number of PWD Outpatient Visits During Study Period
|
4.5 Outpatient Visits
Standard Deviation 12.15
|
3.16 Outpatient Visits
Standard Deviation 4.02
|
SECONDARY outcome
Timeframe: Up to Day 60Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Number of PWD Primary Care Provider Contacts During Study Period
|
0.64 Primary Care Provider Contacts
Standard Deviation 0.86
|
0.68 Primary Care Provider Contacts
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Baseline, Day 6022-item self-assessment of burden experienced by caregivers. Items are ranked on a Likert scale from 0 (never) to 4 (nearly always). The total score is the sum of responses and ranges from 0 to 88, where: 0 - 21 = little or no burden; 21 - 40 = mild to moderate burden; 41 - 60 = moderate to severe burden; and 61 - 88 = severe burden. An increase in scores indicates burden increased during the observational period.
Outcome measures
| Measure |
QI Program Care
n=117 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=95 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Zarit Burden Inventory Score Among Caregivers
|
29.65 score on a scale
Standard Deviation 16.21
|
26.14 score on a scale
Standard Deviation 13.45
|
SECONDARY outcome
Timeframe: Baseline, Day 609-item measurement of depression in which caregivers indicate how often they have been bothered by specific problems over the previous 2 weeks. Items are ranked on 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater severity of depression.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Public Health Questionnaire-9 (PHQ-9) Score Among Caregivers
|
4.8 score on a scale
Standard Deviation 5.03
|
4.27 score on a scale
Standard Deviation 4.04
|
SECONDARY outcome
Timeframe: Baseline, Day 6012-item tool that measures functional health and well-being. Two summary scores are reported from the SF-12: a mental component score (MCS-12) and a physical component score (PCS-12). Physical Composite Scores (PCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Short-Form-12 - Physical Subscale (PCS-12) Score Among Caregivers
|
47.15 score on a scale
Standard Deviation 11.13
|
47.13 score on a scale
Standard Deviation 11.36
|
SECONDARY outcome
Timeframe: Baseline, Day 6012-item tool that measures functional health and well-being. Two summary scores are reported from the SF-12: a mental component score (MCS-12) and a physical component score (PCS-12). Mental Health Composite Scores (MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Outcome measures
| Measure |
QI Program Care
n=119 Participants
DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
|
Control
n=96 Participants
receive usual care from a care team who has not received the performance improvement program
Standard of Care: Subjects receive care through usual home healthcare assignment process.
|
|---|---|---|
|
Change in Short-Form-12 - Mental Health Subscale (MCS-12) Score Among Caregivers
|
46.63 score on a scale
Standard Deviation 11.8
|
47.59 score on a scale
Standard Deviation 9.26
|
Adverse Events
QI Program Care - PWD
Serious events: 26 serious events
Other events: 21 other events
Deaths: 6 deaths
QI Program Care - Caregiver
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Control - PWD
Serious events: 34 serious events
Other events: 9 other events
Deaths: 10 deaths
Control - Caregiver
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QI Program Care - PWD
n=119 participants at risk
Patients with dementia (PWD) assigned to the QI program care arm as part of a Patient-Caregiver dyad.
|
QI Program Care - Caregiver
n=119 participants at risk
Caregivers assigned to the QI program care arm as part of a Patient-Caregiver dyad.
|
Control - PWD
n=96 participants at risk
Patients with dementia (PWD) assigned to the control arm as part of a Patient-Caregiver dyad.
|
Control - Caregiver
n=96 participants at risk
Caregivers assigned to the control arm as part of a Patient-Caregiver dyad.
|
|---|---|---|---|---|
|
General disorders
Hospitalization
|
12.6%
15/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
19.8%
19/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
2.1%
2/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
|
Psychiatric disorders
Caregiver severe depression (Increase Score on PHQ-9 [Day 60])
|
0.00%
0/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
1.7%
2/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
2.1%
2/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
|
Psychiatric disorders
Caregiver suicide idealization
|
0.00%
0/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.84%
1/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
|
General disorders
Death related
|
5.0%
6/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
10.4%
10/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
|
Psychiatric disorders
Delirium
|
4.2%
5/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
5.2%
5/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
Other adverse events
| Measure |
QI Program Care - PWD
n=119 participants at risk
Patients with dementia (PWD) assigned to the QI program care arm as part of a Patient-Caregiver dyad.
|
QI Program Care - Caregiver
n=119 participants at risk
Caregivers assigned to the QI program care arm as part of a Patient-Caregiver dyad.
|
Control - PWD
n=96 participants at risk
Patients with dementia (PWD) assigned to the control arm as part of a Patient-Caregiver dyad.
|
Control - Caregiver
n=96 participants at risk
Caregivers assigned to the control arm as part of a Patient-Caregiver dyad.
|
|---|---|---|---|---|
|
Nervous system disorders
Increase in symptoms of dementia
|
5.9%
7/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
1.0%
1/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
|
General disorders
Change in pre-existing condition
|
0.84%
1/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
3.4%
4/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
|
General disorders
New Diagnosis
|
0.00%
0/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
1.0%
1/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
|
Injury, poisoning and procedural complications
Fall
|
7.6%
9/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
6.2%
6/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
|
Psychiatric disorders
Depressive Symptoms (Score on PHQ-9)
|
0.00%
0/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.84%
1/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
1.0%
1/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
|
Injury, poisoning and procedural complications
Injury not life threatening
|
1.7%
2/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
1.0%
1/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
|
Psychiatric disorders
Delirium False Positive
|
1.7%
2/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/119 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
0.00%
0/96 • 60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place