Trial Outcomes & Findings for Implementation of MIND at Home Into Primary Care for People Living With Dementia (NCT NCT05406921)
NCT ID: NCT05406921
Last Updated: 2025-01-31
Results Overview
Hospital transfers include hospitalizations, emergency department visits, and observation stays without admission.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
410 participants
Primary outcome timeframe
Data will be collected monthly for the 3 months prior to enrollment, the 3 months during enrollment, and one month post enrollment.
Results posted on
2025-01-31
Participant Flow
Participant milestones
| Measure |
Intervention Arm: PLWD
105 community-residing PC patients with an ADRD diagnosis were enrolled and received MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.
MIND at Home: Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.
|
Data Validation Arm
An additional 200 PLWD served as a data validation arm to demonstrate the feasibility of collecting and validating data from large health systems.
|
Intervention Arm: PLWD CPs
105 Care Partners (CPs) of the 105 community-residing PC patients with an ADRD diagnosis were enrolled and received MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.
MIND at Home: Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.
|
|---|---|---|---|
|
Overall Study
STARTED
|
105
|
200
|
105
|
|
Overall Study
COMPLETED
|
80
|
188
|
80
|
|
Overall Study
NOT COMPLETED
|
25
|
12
|
25
|
Reasons for withdrawal
| Measure |
Intervention Arm: PLWD
105 community-residing PC patients with an ADRD diagnosis were enrolled and received MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.
MIND at Home: Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.
|
Data Validation Arm
An additional 200 PLWD served as a data validation arm to demonstrate the feasibility of collecting and validating data from large health systems.
|
Intervention Arm: PLWD CPs
105 Care Partners (CPs) of the 105 community-residing PC patients with an ADRD diagnosis were enrolled and received MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.
MIND at Home: Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
25
|
0
|
25
|
|
Overall Study
Protocol Violation
|
0
|
12
|
0
|
Baseline Characteristics
Implementation of MIND at Home Into Primary Care for People Living With Dementia
Baseline characteristics by cohort
| Measure |
Intervention Arm: PLWD
n=80 Participants
105 community-residing PC patients with an ADRD diagnosis were enrolled and received MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.
MIND at Home: Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia-care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.
|
Data Validation Arm
n=188 Participants
An additional 200 PLWD served as a data validation arm to demonstrate the feasibility of collecting and validating data from large health systems.
|
Intervention Arm: PLWD CPs
n=80 Participants
105 Care Partners (CPs) of the 105 community-residing PC patients with an ADRD diagnosis were enrolled and received MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.
MIND at Home: Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia-care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.
|
Total
n=348 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
81 years
STANDARD_DEVIATION 6.18 • n=99 Participants
|
79 years
STANDARD_DEVIATION 9.16 • n=107 Participants
|
NA years
STANDARD_DEVIATION NA • n=206 Participants
|
80 years
STANDARD_DEVIATION 7.00 • n=7 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
188 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
160 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=99 Participants
|
183 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
339 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=99 Participants
|
158 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
297 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=99 Participants
|
188 participants
n=107 Participants
|
80 participants
n=206 Participants
|
348 participants
n=7 Participants
|
|
hospital transfers
|
1.89 hospital transfers per 1000 person days
STANDARD_DEVIATION 5.78 • n=99 Participants
|
2.50 hospital transfers per 1000 person days
STANDARD_DEVIATION 8.29 • n=107 Participants
|
NA hospital transfers per 1000 person days
STANDARD_DEVIATION NA • n=206 Participants
|
2.07 hospital transfers per 1000 person days
STANDARD_DEVIATION 6.62 • n=7 Participants
|
PRIMARY outcome
Timeframe: Data will be collected monthly for the 3 months prior to enrollment, the 3 months during enrollment, and one month post enrollment.Population: Per-protocol analysis.
Hospital transfers include hospitalizations, emergency department visits, and observation stays without admission.
Outcome measures
| Measure |
Intervention Arm: PLWD
n=80 Participants
105 community-residing PC patients with an ADRD diagnosis were enrolled and received MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.
MIND at Home: Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia-care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.
|
Data Validation Arm
n=188 Participants
An additional 200 PLWD served as a data validation arm to demonstrate the feasibility of collecting and validating data from large health systems.
|
Intervention Arm: PLWD CPs
n=80 Participants
105 Care Partners (CPs) of the 105 community-residing PC patients with an ADRD diagnosis were enrolled and received MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.
MIND at Home: Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia-care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.
|
|---|---|---|---|
|
Change in Number of Hospital Transfers Pre/Post Intervention
|
0.97 hospital transfers per 1000 person days
Standard Deviation 7.94
|
0.65 hospital transfers per 1000 person days
Standard Deviation 7.10
|
NA hospital transfers per 1000 person days
Standard Deviation NA
We did not collect outcomes on CPs.
|
SECONDARY outcome
Timeframe: Data will be collected monthly for the 3 months prior to enrollment, the 3 months during enrollment, and one month post enrollment.Population: Only one site was able to provide data on total medications.
The secondary outcomes are number of total medications, number of anti-psychotics, acetylcholinesterase inhibitors, and memantine medications.
Outcome measures
| Measure |
Intervention Arm: PLWD
n=46 Participants
105 community-residing PC patients with an ADRD diagnosis were enrolled and received MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.
MIND at Home: Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia-care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.
|
Data Validation Arm
n=100 Participants
An additional 200 PLWD served as a data validation arm to demonstrate the feasibility of collecting and validating data from large health systems.
|
Intervention Arm: PLWD CPs
n=46 Participants
105 Care Partners (CPs) of the 105 community-residing PC patients with an ADRD diagnosis were enrolled and received MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.
MIND at Home: Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia-care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.
|
|---|---|---|---|
|
Change in Number of Medications Pre/Post Intervention
|
-0.43 number of medications
Standard Deviation 3.99
|
0.33 number of medications
Standard Deviation 2.44
|
NA number of medications
Standard Deviation NA
We did not collect outcome data on CPs.
|
Adverse Events
Intervention Arm: PLWD
Serious events: 29 serious events
Other events: 0 other events
Deaths: 2 deaths
Data Validation Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Arm: PLWD CPs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention Arm: PLWD
n=105 participants at risk
80 community-residing PC patients with an ADRD diagnosis were enrolled and received MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.
MIND at Home: Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia-care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.
|
Data Validation Arm
An additional 188 PLWD served as a data validation arm to demonstrate the feasibility of collecting and validating data from large health systems.
|
Intervention Arm: PLWD CPs
80 Care Partners (CPs) of the 105 community-residing PC patients with an ADRD diagnosis were enrolled and received MIND coordination services for 3 months to test program implementation feasibility in PC practice settings.
MIND at Home: Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia-care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Hospitalization
|
6.7%
7/105 • Number of events 7 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Cardiac disorders
Hospitalization
|
0.95%
1/105 • Number of events 1 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
6.7%
7/105 • Number of events 7 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Nervous system disorders
Change in level of care
|
4.8%
5/105 • Number of events 5 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Investigations
Hospitalization
|
0.95%
1/105 • Number of events 1 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Nervous system disorders
ED Visit
|
2.9%
3/105 • Number of events 6 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Social circumstances
Changed Level of Care
|
0.95%
1/105 • Number of events 1 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Injury, poisoning and procedural complications
ED Visit
|
1.9%
2/105 • Number of events 2 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Gastrointestinal disorders
ED Visit
|
1.9%
2/105 • Number of events 2 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
—
0/0 • Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.
We did not collect AEs on Care Partners nor were we able to given that they were not necessarily patients of the same health systems with which we partnered. We did not collect AEs on patients in the data validation arm as we had no contact with those patients. In both of these groups, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place