Mobile App to Promote Family Caregiver Engagement in the Intensive Care Unit

NCT05157919 | Completed

• 1 other identifier: 0625-17-EP
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Family; Critical Care; Mobile Applications

Keywords

Caregiver; Critical Illness; Family; Psychological Distress; Family-Centered Nursing

Outcome Measures

Primary Outcomes (4)

• Enrollment Feasibility of ICU-CARE

  Total subjects screened, approached, consented and refused

  Through study completion, estimated 3 years.

• Sustainability of ICU-CARE enrollment

  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

  Number of doses of the intervention per participant

  Through study completion, estimated 3 years.

• Acceptability of ICU-CARE

  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 Outcomes (16)

• Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver 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

  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

  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

  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

  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.

Study Arms (2)

Control

NO 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.

Intervention with App

EXPERIMENTAL

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

Interventions

ICU-Care BEHAVIORAL

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

Intervention with App

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Nebraska Medicine

Omaha, Nebraska, 68105, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Breanna D Hetland, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: December 15, 2021
• Study Start: January 6, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)