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

M.D. Anderson Cancer Center

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Sleep

Treatments: Device: ViSi Mobile device; Drug: Sleep enhancement intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05456360

NCI-2022-05712 (Other Identifier)

2022-0190

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

89 participants in 2 patient groups

Intervention group

Other group

Description:

Participants will receive sleep enhancement intervention and will wear the ViSi Mobile device.

Treatment:

Device: ViSi Mobile device

Control group

Other group

Description:

Participants will receive sleep enhancement intervention only. Participants in the control group will not wear the ViSi Mobile device.

Treatment:

Drug: Sleep enhancement intervention