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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05456360
• Other study ID #: 2022-0190
• Secondary ID: NCI-2022-05712
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 31, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (> 18 years of age), english speaking, able to complete consent and survey materials.

• 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:

• Vulnerable populations (pregnancy, incarcerated, history of delirium, suicidal ideation, ischemic stroke with measurable neurologic deficit, cerebral palsy, seizures), primary brain tumor/metastases patients.

• 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.

Related Conditions & MeSH terms

• Sleep

Intervention

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

Drug:
• Sleep enhancement intervention
Participants will receive a medication administration will be limited to before bedtime.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life Questionnaires (EuroQol Group EQ-5D)	Score Scales (0-100) 0-worst health/100 best health	through study completion, an average of 1 year

External Links

•   MD Anderson Cancer Center