Trial Outcomes & Findings for Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study (NCT NCT03832192)
NCT ID: NCT03832192
Last Updated: 2023-08-14
Results Overview
For each patient without prevalent delirium (each patient who screens negative per the Confusion Assessment Method \[CAM\] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), Incident Delirium is indicated by any positive CAM screen during the patient's study enrollment period, with CAM screens being performed at least daily (the final CAM screen is assumed to be within 24 hours of discharge from the hospital unit). Incident Delirium is thus a binary variable (true/false) for each patient, and the rate of Incident Delirium will be compared across study groups, with a lower rate being desirable.
COMPLETED
PHASE2
301 participants
From beginning to end of each participant's inpatient stay, an average of 4 days
2023-08-14
Participant Flow
Participant milestones
| Measure |
Intervention
HELP-protocolized digital avatar with daily nurse student check-in
|
Control
Usual care with daily nurse student social check-in
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
149
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
152
|
149
|
Reasons for withdrawal
| Measure |
Intervention
HELP-protocolized digital avatar with daily nurse student check-in
|
Control
Usual care with daily nurse student social check-in
|
|---|---|---|
|
Overall Study
Participants are disenrolled upon hospital discharge.
|
152
|
149
|
Baseline Characteristics
Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study
Baseline characteristics by cohort
| Measure |
Intervention
n=152 Participants
HELP-protocolized digital avatar with daily nurse student check-in
|
Control
n=149 Participants
Usual care with daily nurse student social check-in
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76 years
STANDARD_DEVIATION 9 • n=5 Participants
|
75 years
STANDARD_DEVIATION 8 • n=7 Participants
|
76 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
119 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Short Portable Mental Status Questionnaire
|
2.0 number of questions incorrectly answered
STANDARD_DEVIATION 1.8 • n=5 Participants
|
2.6 number of questions incorrectly answered
STANDARD_DEVIATION 2.4 • n=7 Participants
|
2.3 number of questions incorrectly answered
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Confusion Assessment Method
|
23 number of positive screens
n=5 Participants
|
8 number of positive screens
n=7 Participants
|
31 number of positive screens
n=5 Participants
|
|
Memorial Delirium Assessment Scale
|
8.2 scores on a scale
STANDARD_DEVIATION 4.6 • n=5 Participants
|
14.3 scores on a scale
STANDARD_DEVIATION 4.6 • n=7 Participants
|
12.6 scores on a scale
STANDARD_DEVIATION 5.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: From beginning to end of each participant's inpatient stay, an average of 4 daysPopulation: Patients without prevalent delirium and have a final CAM screen on record
For each patient without prevalent delirium (each patient who screens negative per the Confusion Assessment Method \[CAM\] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), Incident Delirium is indicated by any positive CAM screen during the patient's study enrollment period, with CAM screens being performed at least daily (the final CAM screen is assumed to be within 24 hours of discharge from the hospital unit). Incident Delirium is thus a binary variable (true/false) for each patient, and the rate of Incident Delirium will be compared across study groups, with a lower rate being desirable.
Outcome measures
| Measure |
Intervention
n=87 Participants
HELP-protocolized digital avatar with daily nurse student check-in
|
Control
n=65 Participants
Usual care with daily nurse student social check-in
|
|---|---|---|
|
Incident Delirium Rate
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From beginning to end of each participant's inpatient stay, an average of 4 daysPopulation: Patients with prevalent delirium and a final CAM screen on record
For each patient with prevalent delirium (each patient who screens positive per the Confusion Assessment Method \[CAM\] upon study enrollment, which is assumed to be within 24 hours of admission to the hospital unit), delirium will be considered resolved if the patient's final CAM screen (which is assumed to be within 24 hours prior to discharge from the hospital unit) indicates no delirium. Delirium Resolution is thus a binary variable (true/false) for each patient, and the rate of successful Delirium Resolution will be compared across study groups, with a higher rate being desirable.
Outcome measures
| Measure |
Intervention
n=5 Participants
HELP-protocolized digital avatar with daily nurse student check-in
|
Control
n=8 Participants
Usual care with daily nurse student social check-in
|
|---|---|---|
|
Delirium Resolution Rate
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From beginning to end of each participant's inpatient stay, an average of 4 daysPopulation: Patients with both pre- and post-test data on record
For each patient, the Short Portable Mental Status Questionnaire (SPMSQ) is administered to measure cognitive function (0-10 errors, more errors indicating greater cognitive impairment) upon enrollment and upon dis-enrollment from the study. Change in Cognitive Function is the difference from the enrollment SPMSQ score to the dis-enrollment SPMSQ score. Change in Cognitive Function will be compared across study groups, with a larger numerical reduction being desirable.
Outcome measures
| Measure |
Intervention
n=87 Participants
HELP-protocolized digital avatar with daily nurse student check-in
|
Control
n=68 Participants
Usual care with daily nurse student social check-in
|
|---|---|---|
|
Change in Cognitive Function
|
0.14 score on a scale
Standard Deviation 1.8
|
-0.15 score on a scale
Standard Deviation 2.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From beginning to end of each participant's inpatient stay, an average of 4 daysPopulation: Patients with both pre- and post-test MDAS data
For each patient screened delirium positive on the Confusion Assessment Method (CAM), the Memorial Delirium Assessment Scale (MDAS) is administered to measure delirium severity upon enrollment and upon dis-enrollment from the study. Change in Delirium Severity is the difference from the enrollment MDAS score to the dis-enrollment MDAS score. Change in Delirium Severity will be compared across study groups, with a larger numerical reduction being desirable.
Outcome measures
| Measure |
Intervention
n=1 Participants
HELP-protocolized digital avatar with daily nurse student check-in
|
Control
n=1 Participants
Usual care with daily nurse student social check-in
|
|---|---|---|
|
Change in Delirium Severity
|
-2 score on a scale
|
-5 score on a scale
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place