Mobile App to Promote Family Caregiver Engagement in the Intensive Care Unit (ICU-CARE)

January 2, 2024 updated by: University of Nebraska

Evaluation of a Mobile App to Promote Family Caregiver Engagement in Symptom Assessment and Management During Mechanical Ventilation in the Intensive Care Unit

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Critical care guidelines call for the liberal inclusion of family caregivers into bedside care, but despite convincing evidence that active family participation improves the patient and family experience as well as safety, quality, and delivery of care, critical care nurses have few evidence-based strategies to engage family caregivers as active participants in the provision of care in the intensive care unit (ICU). The broad objective of this proposal is to develop and test a mobile app, Intensive Care Unit-Caregiver Activation Response and Engagement [ICU-CARE]. ICU-CARE provides a simulated learning environment that incorporates established motivational learning theories to encourage family caregivers of mechanically ventilated patients to assess two patient symptoms, thirst and anxiety, and perform specific nonpharmacologic symptom management techniques to help alleviate the patient's symptom burden. This project, guided by the Individual and Family Self-Management Theory, aims to (1) Establish the feasibility and acceptability of the ICU-CARE intervention for family caregivers enrolled in the experimental arm; and (2) Determine the influence of the ICU-CARE intervention on the caregiver process characteristics, proximal caregiving outcomes, and distal caregiving outcomes as compared to family caregivers enrolled in the control arm. To address these study aims, a convenience sample of 60 family caregivers of mechanically ventilated patients will be recruited into this randomized controlled pilot trial. 30 participants will be enrolled to the control group which will receive usual care with routine caregiver support practices. Intervention participants (n=30) will be enrolled to an experimental condition ICU-CARE, that will consist of a theoretically grounded mobile app program to promote caregiver engagement in symptom assessment and management in the ICU. This project will help further define the scope, extent, and nature of patient and family engagement in the ICU, and if proven feasible, our intervention holds the potential to shift the ICU nursing practice paradigm by integrating family caregivers as dynamic partners in ICU care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Nebraska Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Adult Caregivers of mechanically ventilated ICU patients who are:

  • Age 19 or older
  • Able to understand English
  • Able and willing to use the hospital-provided tablet devices
  • Can view images on a screen and hear audio through a standard headset
  • Have basic reading skills and the ability to read aloud

Critically ill patients in the ICU who are:

  • Age 19 or older
  • Mechanically ventilated
  • Expected to require> 72 consecutive hours of mechanical ventilation during their ICU stay
  • Calm, cooperative (a Richmond Agitation-Sedation Scale score between -5 and +1)
  • Able to reliably report symptoms of thirst and anxiety per nursing assessment
  • Have no documented hearing deficits
  • Have a designated caregiver who visits frequently (daily for a minimum of 1 hour)

Exclusion Criteria:

Adult Caregivers of mechanically ventilated ICU patients who are:

  • Caregivers of patients who are not currently undergoing mechanical ventilation
  • Caregivers of patients who are not calm, cooperative (a Richmond Agitation- - Sedation Scale score between +2 and +4),
  • Caregivers of patients who cannot reliably report symptoms of thirst and anxiety
  • Caregivers of patients who have a documented hearing deficit.
  • Caregivers who do not visit the patient frequently (at least once per day for a minimum of 1 hour as described by nursing staff)

Critically ill patients in the ICU who are:

  • Recovering from any of the following surgeries: Glossectomy, Maxillectomy, Neck Dissection, Facial/neck flap
  • Receiving aggressive ventilator support such as positive end expiratory pressure> 15cm of water, prone ventilation
  • Not alert per nursing assessment (Richmond Agitation-Sedation Scale Score +2 or greater)
  • Severe cognition or communication problems (i.e. coma as the main reason for intubation, dementia, severe delirium)
  • Deafness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
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.
Experimental: Intervention with App
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.
Behavioral: ICU-Care
The mobile app intervention, ICU-CARE, will consist of 3 separate education modules, each approximately 5-7 minutes in length: (Module #1) ICU orientation, (Module #2) Symptom Assessment, (Module #3) Symptom Management

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Enrollment Feasibility of ICU-CARE
Time Frame: Through study completion, estimated 3 years.
Total subjects screened, approached, consented and refused
Through study completion, estimated 3 years.
Sustainability of ICU-CARE enrollment
Time Frame: Through study completion, estimated 3 years.
Differential attrition rates - the number of subjects in each group that complete all study follow-up measures
Through study completion, estimated 3 years.
Dosage of ICU-CARE
Time Frame: Through study completion, estimated 3 years.
Number of doses of the intervention per participant
Through study completion, estimated 3 years.
Acceptability of ICU-CARE
Time Frame: Through study completion, estimated 3 years.
Total score of a modified version of the Educational Material Acceptability Instrument. Minimum Score = 11; Maximum Score = 55. Higher score indicates greater acceptance.
Through study completion, estimated 3 years.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Activation
Time Frame: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
Caregiver activation as measured by Patient Activation Measure for Family Caregivers (CG-PAM). Minimum score = 1; Maximum Score = 4. Higher score indicates greater activation.
At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Self-efficacy
Time Frame: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
Caregiver self-efficacy as measured by the Caregiver Self-Efficacy Scale (CaSES). Scale contains four sub-scales that are scored separately. Minimum Score =1; Maximal Score = 5. Higher scores indicate greater self-efficacy.
At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Preparedness
Time Frame: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
Caregiver Preparedness as measured by the Preparedness for Caregiving Scale (Prep Scale). Minimum score = 0; Maximum score = 32. The higher the score the more prepared the caregiver feels for caregiving.
At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Proximal Caregiving Outcomes - Symptom Assessment
Time Frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Rate of symptom assessment behaviors - the number of times in a 24 hour period that the subject records a patient symptom assessment in the ICU-CARE app
Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Symptom Management
Time Frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Rate of symptom management behaviors - the number of times in a 24 hour period that the subject records a patient symptom management technique in the ICU-CARE app
Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Caregiver Anxiety
Time Frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Caregiver anxiety as measured by the State-Trait Anxiety Inventory (STAI-State). Minimum score = 0; Maximum score = 6. Higher scores indicate greater anxiety.
Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Patient Thirst
Time Frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Patient thirst as measured by a 0-100 visual analogue scale for thirst (VAS-Thirst)
Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Patient Anxiety
Time Frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Patient anxiety as measured by a 0-100 visual analogue scale for anxiety (VAS-Anxiety)
Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Global Health Status
Time Frame: At study enrollment and 2-4 weeks after ICU discharge
Caregiver Global Health Status as measured by the Patient-Reported Outcome Measure (PROMIS-10). 5 questions each on 2 (1-5) subscales (Global Physical Health, Global Mental Health). Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks. Higher scores indicate a healthier patient.
At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Anxiety & Depressive Symptoms
Time Frame: At study enrollment and 2-4 weeks after ICU discharge
Caregiver anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS). Two sub-scales (Anxiety & Depression) scored separately. Minimum Score = 0; Maximum Score = 21. Higher score = higher anxiety and/or depression.
At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Satisfaction
Time Frame: At study enrollment and 2-4 weeks after ICU discharge
Caregiver satisfaction as measured by the Critical Care Family Satisfaction Survey (CCFSS). Minimum Score = 5; Maximum score = 25. Higher scores indicate greater satisfaction.
At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver ICU Experience
Time Frame: At study enrollment and 2-4 weeks after ICU discharge
Overall impact of ICU experience for caregivers as measured by the Impact of Events Scale-Revised. Minimum Score = 0; Maximum Score = 88. Higher score indicates great impact of life event.
At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Patient Agitation
Time Frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Nurse documentation of patient agitation in the electronic health record
Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Patient Pain
Time Frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Nurse documentation of patient pain in the electronic health record
Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Duration of Ventilation
Time Frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Duration of mechanical ventilation
Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Sedative Exposure
Time Frame: Through study completion, estimated 3 years.
Sedative exposure (sedation intensity and sedation frequency)
Through study completion, estimated 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Breanna D Hetland, PhD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0625-17-EP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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