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Trial Outcomes & Findings for Implementation of Digital Vital Sign Monitoring to Decrease Sleep Interruption and Enhance Recovery in Phase II of the PROmoting Sleep, Patient Engagement and Recovery (PROSPER) Project (NCT NCT05456360)

NCT ID: NCT05456360

Last Updated: 2024-12-18

Results Overview

Score Scales (0-100) 0-worst health/100 best health

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

89 participants

Primary outcome timeframe

through study completion, an average of 1 year

Results posted on

2024-12-18

Participant Flow

Between March 2023 and October 2023, we enrolled 89 patients. 52 patients were assigned to the control group, while 37 were assigned to the intervention group. The study was terminated due to insufficient staff and the inability to enroll an adequate number of patients. Consequently, we could not draw any conclusions.

Participant milestones

Participant milestones
Measure
Standard of Care
Vital Signs were monitor per standard of care
Intervention: Passive Vital Signs Monitoring
Vital Signs were monitor per PROSPER algorithm
Overall Study
STARTED
52
37
Overall Study
COMPLETED
16
9
Overall Study
NOT COMPLETED
36
28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Implementation of Digital Vital Sign Monitoring to Decrease Sleep Interruption and Enhance Recovery in Phase II of the PROmoting Sleep, Patient Engagement and Recovery (PROSPER) Project

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Standard of Care
n=52 Participants
Vital Signs were monitor per standard of care
Intervention: Passive Vital Signs Monitoring
n=37 Participants
Vital Signs were monitor per PROSPER algorithm
Total
n=89 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
34 Participants
n=5 Participants
22 Participants
n=7 Participants
56 Participants
n=5 Participants
Age, Categorical
>=65 years
18 Participants
n=5 Participants
15 Participants
n=7 Participants
33 Participants
n=5 Participants
Sex: Female, Male
Female
30 Participants
n=5 Participants
10 Participants
n=7 Participants
40 Participants
n=5 Participants
Sex: Female, Male
Male
22 Participants
n=5 Participants
27 Participants
n=7 Participants
49 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
45 Participants
n=5 Participants
34 Participants
n=7 Participants
79 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=5 Participants
3 Participants
n=7 Participants
7 Participants
n=5 Participants
Race (NIH/OMB)
White
47 Participants
n=5 Participants
31 Participants
n=7 Participants
78 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
52 participants
n=5 Participants
37 participants
n=7 Participants
89 participants
n=5 Participants

PRIMARY outcome

Timeframe: through study completion, an average of 1 year

Population: Based on the feedback from the team it was unrealistic to complete the protocol in the estimated period due to lack of patient interest and engagement, data was not collected.

Score Scales (0-100) 0-worst health/100 best health

Outcome measures

Outcome data not reported

Adverse Events

Standard of Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intervention: Passive Vital Signs Monitoring

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

Dr. Vijaya Gottumukkala

The University of Texas MD Anderson Cancer Center

Phone: (713) 794-1398

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place