Trial Outcomes & Findings for Development and Piloting an Avatar-based Intervention to Support Patients Undergoing Stem Cell Transplantation (NCT NCT05600101)
NCT ID: NCT05600101
Last Updated: 2024-07-03
Results Overview
Participants complete study protocol, including post-completion survey, from enrollment to hospital discharge or 3 weeks from enrollment (whichever is earlier).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Baseline to 3 weeks
Results posted on
2024-07-03
Participant Flow
Recruitment was conducted by a trained research assistant (RA) utilizing HIPAA-compliant and DFCI IRB approved patient approach procedures. A total of 18 participants were consented. Patients were approached and consented upon inpatient admission for RIC HCT. Patients were consented beginning on 12/6/2022 through 5/3/2023.
There were no significant events in the study for any patients between their enrollment and assignment to an arm or group of the study.
Participant milestones
| Measure |
Care.Coach Pilot
The research study procedures include screening for eligibility, a brief call with a research assistant after tablet is given to subject, and a survey after a subject has completed the study.
* 3 consecutive cohorts of 6 RIC HCT patients each.
* care.coach is a "human-in the-loop" conversational agent (avatar) used to interact and converse with patients through natural dialogue and text-to-speech software that is powered by a team of trained human staff, called health advocates. A subject uses the avatar for up to 3 weeks.
Care.Coach: Care.coach is a "human-in the-loop" conversational agent (avatar) used to interact and converse with patients through natural dialogue and text-to-speech software that is powered by a team of trained human staff, called health advocates.
|
AI HCT Focus Group
A structured focus group arm consisted of HCT nurse navigators, inpatient HCT nurses, and HCT physicians. Participants provided their perspectives on patient facing artificial intelligence technology which was used to inform care.coach software protocols. Participation was limited to a single 60 minute focus group. The group consisted of of 2 bedside registered nurses, 1 oncology nurse, 3 transplant physicians, 1 physical therapist, 1 transplant nurse practitioner, 1 physician assistant transplant educator, and 1 nurse transplant educator.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
10
|
|
Overall Study
COMPLETED
|
18
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AI HCT Focus Group participant demographics were not analyzed.
Baseline characteristics by cohort
| Measure |
Care.Coach Pilot
n=18 Participants
The research study procedures include screening for eligibility, a brief call with a research assistant after tablet is given to subject, and a survey after a subject has completed the study.
* 3 consecutive cohorts of 6 RIC HCT patients each.
* care.coach is a "human-in the-loop" conversational agent (avatar) used to interact and converse with patients through natural dialogue and text-to-speech software that is powered by a team of trained human staff, called health advocates. A subject uses the avatar for up to 3 weeks.
Care.Coach: Care.coach is a "human-in the-loop" conversational agent (avatar) used to interact and converse with patients through natural dialogue and text-to-speech software that is powered by a team of trained human staff, called health advocates.
|
AI HCT Focus Group
n=10 Participants
A structured focus group arm consisted of HCT nurse navigators, inpatient HCT nurses, and HCT physicians. Participants provided their perspectives on patient facing artificial intelligence technology which was used to inform care.coach software protocols. Participation was limited to a single 60 minute focus group.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants • AI HCT Focus Group participant demographics were not analyzed.
|
—
|
0 Participants
n=18 Participants • AI HCT Focus Group participant demographics were not analyzed.
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=18 Participants • AI HCT Focus Group participant demographics were not analyzed.
|
—
|
11 Participants
n=18 Participants • AI HCT Focus Group participant demographics were not analyzed.
|
|
Age, Categorical
>=65 years
|
7 Participants
n=18 Participants • AI HCT Focus Group participant demographics were not analyzed.
|
—
|
7 Participants
n=18 Participants • AI HCT Focus Group participant demographics were not analyzed.
|
|
Sex: Female, Male
Female
|
11 Participants
n=18 Participants • AI HCT Focus Group Participants demographics were not analyzed.
|
—
|
11 Participants
n=18 Participants • AI HCT Focus Group Participants demographics were not analyzed.
|
|
Sex: Female, Male
Male
|
7 Participants
n=18 Participants • AI HCT Focus Group Participants demographics were not analyzed.
|
—
|
7 Participants
n=18 Participants • AI HCT Focus Group Participants demographics were not analyzed.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants • AI HCT Focus Group participants demographics were not analyzed
|
—
|
0 Participants
n=18 Participants • AI HCT Focus Group participants demographics were not analyzed
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=18 Participants • AI HCT Focus Group participants demographics were not analyzed
|
—
|
2 Participants
n=18 Participants • AI HCT Focus Group participants demographics were not analyzed
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants • AI HCT Focus Group participants demographics were not analyzed
|
—
|
0 Participants
n=18 Participants • AI HCT Focus Group participants demographics were not analyzed
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=18 Participants • AI HCT Focus Group participants demographics were not analyzed
|
—
|
1 Participants
n=18 Participants • AI HCT Focus Group participants demographics were not analyzed
|
|
Race (NIH/OMB)
White
|
13 Participants
n=18 Participants • AI HCT Focus Group participants demographics were not analyzed
|
—
|
13 Participants
n=18 Participants • AI HCT Focus Group participants demographics were not analyzed
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants • AI HCT Focus Group participants demographics were not analyzed
|
—
|
0 Participants
n=18 Participants • AI HCT Focus Group participants demographics were not analyzed
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=18 Participants • AI HCT Focus Group participants demographics were not analyzed
|
—
|
2 Participants
n=18 Participants • AI HCT Focus Group participants demographics were not analyzed
|
|
Region of Enrollment
United States
|
18 Participants
n=18 Participants
|
10 Participants
n=10 Participants
|
28 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 weeksParticipants complete study protocol, including post-completion survey, from enrollment to hospital discharge or 3 weeks from enrollment (whichever is earlier).
Outcome measures
| Measure |
Care.Coach Pilot
n=18 Participants
The research study procedures include screening for eligibility, a brief call with a research assistant after tablet is given to subject, and a survey after a subject has completed the study.
* 3 consecutive cohorts of 6 RIC HCT patients each.
* care.coach is a "human-in the-loop" conversational agent (avatar) used to interact and converse with patients through natural dialogue and text-to-speech software that is powered by a team of trained human staff, called health advocates. A subject uses the avatar for up to 3 weeks.
Care.Coach: Care.coach is a "human-in the-loop" conversational agent (avatar) used to interact and converse with patients through natural dialogue and text-to-speech software that is powered by a team of trained human staff, called health advocates.
|
|---|---|
|
Number of Participants Retained
|
18 Participants
|
SECONDARY outcome
Timeframe: 3 weeksPercent of patients dissatisfied with the avatar in the third 6-patient cohort.
Outcome measures
| Measure |
Care.Coach Pilot
n=6 Participants
The research study procedures include screening for eligibility, a brief call with a research assistant after tablet is given to subject, and a survey after a subject has completed the study.
* 3 consecutive cohorts of 6 RIC HCT patients each.
* care.coach is a "human-in the-loop" conversational agent (avatar) used to interact and converse with patients through natural dialogue and text-to-speech software that is powered by a team of trained human staff, called health advocates. A subject uses the avatar for up to 3 weeks.
Care.Coach: Care.coach is a "human-in the-loop" conversational agent (avatar) used to interact and converse with patients through natural dialogue and text-to-speech software that is powered by a team of trained human staff, called health advocates.
|
|---|---|
|
Final Cohort Dissatisfaction Rate
|
0 percentage of particpants
|
SECONDARY outcome
Timeframe: 3 weeksRate of completion of post-pilot survey within 1 week of discharge
Outcome measures
| Measure |
Care.Coach Pilot
n=18 Participants
The research study procedures include screening for eligibility, a brief call with a research assistant after tablet is given to subject, and a survey after a subject has completed the study.
* 3 consecutive cohorts of 6 RIC HCT patients each.
* care.coach is a "human-in the-loop" conversational agent (avatar) used to interact and converse with patients through natural dialogue and text-to-speech software that is powered by a team of trained human staff, called health advocates. A subject uses the avatar for up to 3 weeks.
Care.Coach: Care.coach is a "human-in the-loop" conversational agent (avatar) used to interact and converse with patients through natural dialogue and text-to-speech software that is powered by a team of trained human staff, called health advocates.
|
|---|---|
|
The Completion Rate Post-Pilot Survey
|
72 Survey Completion Rate Percentage
|
Adverse Events
Care.Coach Pilot
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Focus Group Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place