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

Phase 2

Terminated

• Conditions: Sleep
• Interventions: Device: ViSi Mobile device; Drug: Sleep enhancement intervention

• Registration Number: NCT05456360
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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:

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-13
• Study Start: 2023-03-01
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Results First Submitted: 2024-10-15
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Results First Posted: 2024-12-18
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 89

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	ViSi Mobile device	Participants will receive sleep enhancement intervention and will wear the ViSi Mobile device.
Control group	Sleep enhancement intervention	Participants will receive sleep enhancement intervention only. Participants in the control group will not wear the ViSi Mobile device.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States