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
Study Details
Study Description
Brief Summary
This phase II/III trial examines how a sleep enhancement intervention, including the use of wearable digital vital sign monitoring device (ViSi), affects the quality of life of cancer patients receiving acute care. Sleep enchancement interventions may improve the quality of life of patients with cancer due to fewer interruptions at night during hospital stays.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
Objective:
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:
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. Assess the impact of our sleep enhancement intervention on acute care utilization e.g. length of stay, 30-day readmissions
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. 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).
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. Assess the impact, via validated survey instruments, of our sleep enhancement intervention on patient mood, patient activation and satisfaction with inpatient stay experience.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Intervention group Participants will receive sleep enhancement intervention and will wear the ViSi Mobile device. |
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
|
| Other: Control group Participants will receive sleep enhancement intervention only. Participants in the control group will not wear the ViSi Mobile device. |
Drug: Sleep enhancement intervention
Participants will receive a medication administration will be limited to before bedtime.
|
Outcome Measures
Primary Outcome Measures
- Quality of Life Questionnaires (EuroQol Group EQ-5D) [through study completion, an average of 1 year]
Score Scales (0-100) 0-worst health/100 best health
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients (> 18 years of age), english speaking, able to complete consent and survey materials.
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Patients must be admitted to the hospital for at least 3 nights.
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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:
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Vulnerable populations (pregnancy, incarcerated, history of delirium, suicidal ideation, ischemic stroke with measurable neurologic deficit, cerebral palsy, seizures), primary brain tumor/metastases patients.
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Patients concurrently enrolled in contact isolation with SARS-CoV2 will be excluded.
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Lastly, hospice or hospice-bound patients will also be excluded.
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Any patient can remove themselves from the study at any point.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Vijaya Gottumukkala, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2022-0190
- NCI-2022-05712