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Intervention with App for Family (ICU-CARE Trial)

N/A
Waitlist Available
Led By Breanna D Hetland, PhD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, estimated 3 years.
Awards & highlights

ICU-CARE Trial Summary

The purpose of this randomized controlled pilot trial is to develop and test mobile app, Intensive Care Unit-Caregiver Activation Response, and Engagement (ICU-CARE). ICU-CARE provides a simulated learning environment to encourage family caregivers of mechanically ventilated patients to assess two patient symptoms, thirst and anxiety, and perform specific nonpharmacologic comfort measures to help alleviate patient symptom burden.

Eligible Conditions
  • Family
  • Critical Care
  • Mobile Apps

ICU-CARE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, estimated 3 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, estimated 3 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of ICU-CARE
Dosage of ICU-CARE
Enrollment Feasibility of ICU-CARE
+1 more
Secondary outcome measures
Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Activation
Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Preparedness
Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Self-efficacy
+13 more

ICU-CARE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention with AppExperimental Treatment1 Intervention
The caregiver gets access to use the app. Each day, investigators will ask the patient to rate their thirst and anxiety and the caregiver to answer daily measures through the application. The caregiver will be asked questions at 3 different times: Day 1, 24-48 hours after enrollment, and 2-4 weeks after the patient is discharged from the ICU. The caregiver will be taught how to use the app. The caregiver will be given the supplies that the caregiver needs to perform the symptom management intervention. Investigators will ask the caregiver to use the app at least once a day, but the caregiver can use it as much as desired while the patient is in the ICU.
Group II: ControlActive Control1 Intervention
Usual care continues. The caregiver will not get to use the app. The caregiver will be asked daily measures and the patient will be asked about thirst and anxiety daily when the patient is awake enough to answer these questions. The caregiver will be asked questions at 3 different times: Day 1, 24-48 hours after enrollment, and 2-4 weeks after the patient is discharged from the ICU.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ICU-Care
2020
N/A
~20

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
540 Previous Clinical Trials
1,144,740 Total Patients Enrolled
Breanna D Hetland, PhDPrincipal InvestigatorUniversity of Nebraska
1 Previous Clinical Trials
120 Total Patients Enrolled

Frequently Asked Questions

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~3 spots leftby May 2025