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 ID: NCT05456360
Last Updated: 2024-12-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
89 participants
INTERVENTIONAL
2023-03-01
2023-10-30
Brief Summary
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Detailed Description
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Primary Objective:
1). Investigate the impact of our sleep enhancement intervention, that entails a wearable digital vital sign monitoring device, on variation in the quality of life of acute care cancer patients
Secondary Objectives:
1. . Assess the impact of our sleep enhancement intervention on acute care utilization e.g. length of stay, 30-day readmissions
2. . Assess the implementation and feasibility of wearable digital vital signs capture in an inpatient oncologic setting using validated instruments such as system usability scale (SUS) and Weiner implementation outcomes (AIM, FIM, IAM).
3. . Assess the impact, via validated survey instruments, of our sleep enhancement intervention on patient mood, patient activation and satisfaction with inpatient stay experience.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention group
Participants will receive sleep enhancement intervention and will wear the ViSi Mobile device.
ViSi Mobile device
Participants will wear the device on your wrist like a watch, and it will continuously (non-stop) monitor your pulse, blood pressure, temperature, breathing rate, heart rate, and pulse rate
Control group
Participants will receive sleep enhancement intervention only. Participants in the control group will not wear the ViSi Mobile device.
Sleep enhancement intervention
Participants will receive a medication administration will be limited to before bedtime.
Interventions
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ViSi Mobile device
Participants will wear the device on your wrist like a watch, and it will continuously (non-stop) monitor your pulse, blood pressure, temperature, breathing rate, heart rate, and pulse rate
Sleep enhancement intervention
Participants will receive a medication administration will be limited to before bedtime.
Eligibility Criteria
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Inclusion Criteria
* Patients must be admitted to the hospital for at least 3 nights.
* Patient's using pharmacological sleeping aides will be included in the study as this will help us understand if the intervention will also help patients with pre-exisitng sleep disturbances.
Exclusion Criteria
* Patients concurrently enrolled in contact isolation with SARS-CoV2 will be excluded.
* Lastly, hospice or hospice-bound patients will also be excluded.
* Any patient can remove themselves from the study at any point.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Vijaya Gottumukkala, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2022-05712
Identifier Type: OTHER
Identifier Source: secondary_id
2022-0190
Identifier Type: -
Identifier Source: org_study_id