The Impact of the Family Room App on Caregivers

NCT06463158 | Recruiting FDA Device

• 1 other identifier: 0221-24-EP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Engaging families in patient care during serious illness can enhance care quality, reduce social isolation, boost satisfaction, and lower healthcare costs. However, active involvement of family caregivers remains limited because there are no evidence-based tools to guide clinicians on how to include them effectively. This study will test and refine previously developed point-of-care application, Family Room, and determine its effectiveness by comparison with a control group. A series of surveys will be used to evaluate caregiver well-being, engagement and satisfaction.

Conditions

Well-Being, Psychological; Engagement; Satisfaction, Consumer

Outcome Measures

Primary Outcomes (8)

• Caregiver Engagement - Practical Aspects: FAMily Engagement (FAME) Tool

  The FAMily Engagement (FAME) questionnaire is a self-rated instrument developed to assess current family engagement. Questions address key principles of family-centered care, such as dignity and respect, information sharing, participation, and collaboration. They also address family engagement domains, including family presence, family needs, communication and education, decision making, and direct care. A five-point Likert scale (1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree) is used for responses, which are transformed to a 0-100 scoring system by dividing the sum of the scores by the number of questions answered. Higher scores indicate greater engagement in care and lower scores indicating lesser engagement.

  At study enrollment and within 48 hours of patient participant ICU discharge

• Daily Activity: Family Room Application

  The daily activity logged in the Family Room application at bedside is assessed (intervention group only).

  Daily from enrollment until patient participant ICU discharge, an average of 3 weeks

• Daily Patient Symptoms - Severity of Illness: Acute Physiology and Chronic Health Evaluation (Apache II)

  APACHE II (Acute Physiology and Chronic Health Evaluation II) is a severity-of-disease classification system used in the ICU. An integer score is assessed by medical staff from 0 to 71 is computed based on several measurements. Higher scores correspond to more severe disease and a higher risk of death. Information is taken from the electronic health record.

  Daily from enrollment until patient participant ICU discharge, an average of 3 weeks

• Daily Patient Symptoms: Presence of Lines, Tubes and Equipment

  A daily count of number of lines, tubes and equipment present on ICU patient participant is taken. Information is taken from the electronic health record.

  Daily from enrollment until patient participant ICU discharge, an average of 3 weeks

• Daily Patient Symptoms: Glasgow Coma Scale (GCS)

  The Glasgow Coma Scale (GCS) is assessed by medical staff to describe the extent of impaired consciousness. Patient participants are assessed daily according to three aspects: eye-opening ("1" no response to "4" spontaneous eye opening), motor response ("1" no response to "5" oriented) and verbal response ("1" no response to "6" obeying commands). The total score ranges between 3 and 15. Higher scores indicate better responsiveness. Information is taken from the electronic health record.

  Daily from enrollment until patient participant ICU discharge, an average of 3 weeks

• Daily Patient Symptoms: Pain

  Pain scores are assessed by medical staff daily and range from "0" (no pain) to "10" (the worst pain). Information is taken from the electronic health record.

  Daily from enrollment until patient participant ICU discharge, an average of 3 weeks

• Daily Patient Symptoms: Richmond Agitation-Sedation Scale (RASS)

  The Richmond Agitation-Sedation Scale (RASS) is a nurse assessed 10 point scale, with -5 (unarousable) to +4 (combative). Information is taken from the electronic health record.

  Daily from enrollment until patient participant ICU discharge, an average of 3 weeks

• Daily Patient Symptoms: Confusion Assessment Method for the ICU

  The Confusion Assessment Method for the ICU (CAM-ICU) is a tool to assess the presence of delirium in ICU patient participant who are unable to talk. It involves a sedation assessment and a confusion assessment. The confusion assessment evaluates four features: acute onset or fluctuating course, inattention, disorganized thinking, and altered level of consciousness. A patient participant is considered to be confused if they have feature 1 plus 2 and either 3 or 4 present. The CAM-ICU score ranges from 0 to 4, with 4 being the most severe. Information is taken from the electronic health record.

  Daily from enrollment until patient participant ICU discharge, an average of 3 weeks

Secondary Outcomes (5)

• Caregiver Well-being: Screening Tool for Psychological Distress (STOP-D)

  At study enrollment, every 48 hours while patient participant is in the ICU, and within 48 hours of patient participant ICU discharge

• Caregiver Well-being: Caregiver Self-Assessment Questionnaire

  At study enrollment and within 48 hours of patient participant ICU discharge

• Caregiver Engagement - Psychological Experience: Caregiving Health Engagement Scale (CHE-s)

  At study enrollment and within 48 hours of patient participant ICU discharge

• Caregiver Resilience: Connor-Davidson Resilience Scale (CD-RISC2)

  At study enrollment

• Caregiver Preparedness: Preparedness for Caregiving Scale

  Within 48 hours of patient participant ICU discharge

Study Arms (2)

Control Group - No Intervention

NO INTERVENTION

During the first eight months, participants will be enrolled into the control group which consists of routine care and informational practices by the intensive care unit (ICU) team.

Intervention Group - Family Room Application

EXPERIMENTAL

During the last 10 months, participants will be enrolled into the intervention group where they will use the Family Room application on their personal devices.

Device: Family Room Application

Interventions

Family Room Application DEVICE

The Family Room application is a point of care tool that guides families on contributing to patient participant care by providing real time education, a sense of connection, emotional support, and resources that enable meaningful care giving. Importantly, family caregiver participants receive virtual training on comfort-focused care activities that can be done at the bedside, as well as a mechanism within the electronic health record (EHR) to measure and record the effectiveness of the care they provide.

Intervention Group - Family Room Application

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Present at participant's bedside during the intensive care unit (ICU) admission
• Participant's legally authorized representative (LAR) or designated caregiver to make medical decisions on their behalf

You may not qualify if:

• Not legally authorized representative (LAR) or designated caregiver to make medical decisions on their behalf

Sponsors & Collaborators

• University of Nebraska: lead
• Gordon and Betty Moore Foundation: collaborator

Study Sites (2)

Nebraska Medicine

Omaha, Nebraska, 68105, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

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MeSH Terms

Conditions

Psychological Well-Being; Consumer Behavior

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Breanna Hetland, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Breanna Hetland, PhD

CONTACT

309-231-4537; breanna.hetland@unmc.edu

Study Design

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

Model Details: A clinical trial using a 2-stage sequential cohort design to test the impact of the Family Room on family caregiver well-being, engagement, and satisfaction.

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 17, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)