The Impact of the Family Room App on Caregivers

A Phase I Clinical Trial Evaluating the Impact of the Family Room App on Caregiver Well-being, Satisfaction, and Engagement in the Intensive Care Unit

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.

Study Overview

• Status: Recruiting
• Conditions: Satisfaction, Consumer; Engagement; Well-Being, Psychological
• Intervention / Treatment: Device: Family Room Application

Detailed Description

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.

The investigators will recruit participants from 5 different intensive care units (ICU) to dampen any effects experienced within a single unit. During the first 8 months of recruitment, a convenience sample of up to 50 participants (25 paired caregiver - patient dyads) will be enrolled into the control group which consists of routine care and informational practices of the ICU team. The adult family caregiver participant must be at the patient participant's bedside during ICU admission.

During the last 10 months of recruitment, up to 50 participants (25 paired caregiver - patient dyads) participants will be enrolled into the intervention group where they will use the Family Room application on their personal devices. The Family Room is a point of care tool that guides families on how to contribute to patient care by providing real time education, a sense of connection, emotional support, and resources that enable meaningful caregiving. Caregiver participants will 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.

Data will be collected at 2 timepoints: study enrollment and within 48 hours of patient participant ICU discharge. Caregiver well-being will be measured every 48 hours while the patient participant is admitted to the ICU. Caregiver participant data will be collected through structured interviews using pre-designed questionnaires which will include items related to demographic variables, caregiver participant psychological distress, engagement, and satisfaction. Trained research assistants will conduct either face to face, virtual (via Zoom), or phone interviews depending on the caregiver participant's preference and availability. Patient participant specific data will be extracted from the medical record.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Breanna Hetland, PhD; Phone Number: 309-231-4537; Email: breanna.hetland@unmc.edu

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: Breanna Hetland, PhD; Phone Number: 309-231-4537; Email: breanna.hetland@unmc.edu
      • Contact: Taelyr Weekly, PhD; Phone Number: 402-690-7706; Email: tweekly@childrensnebraska.org
    • Omaha, Nebraska, United States, 68105
      • Recruiting
      • Nebraska Medicine
      • Contact: Breanna Hetland, PhD; Phone Number: 402-559-5460; Email: breanna.hetland@unmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 19 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group - 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.
Experimental: Intervention Group - Family Room Application; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Well-being: Screening Tool for Psychological Distress (STOP-D)	This is a self-rated 5 item instrument which provides severity scores for each of the common psychosocial problem areas: depression, anxiety, stress, anger, and low social support. Scoring is "0" (not at all) to "9" (severely). The higher the score the greater the psychological distress.	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	This is a self-rated 18-item instrument devised by the American Medical Association for physicians to assess the stress-levels of family caregivers. Caregivers are asked to respond either "Yes" or "No" to a series of statements, simple scoring system allows family caregiver themselves to score their results and to determine whether or not they are highly stressed. Points are added for each 'yes' answer for 16 questions plus a 1 to 10 score for a question of current stress levels and for a question on comparing perceived current health compared to a year ago. A higher number means more stress.	At study enrollment and within 48 hours of patient participant ICU discharge
Caregiver Engagement - Psychological Experience: Caregiving Health Engagement Scale (CHE-s)	This is a self-rated 7 item multidimensional instrument to evaluate the impact of burden on different aspects of a caregiver's life. Caregivers respond to a series of statements, indicating their level of agreement or disagreement. The CHE is scored based on a Likert-type scale. The total score reflects the caregiver's overall engagement in healthcare. Higher scores indicate greater engagement.	At study enrollment and within 48 hours of patient participant ICU discharge
Caregiver Resilience: Connor-Davidson Resilience Scale (CD-RISC2)	This is a self-rated 2 item instrument that measures resilience as it relates to ability to thrive in the face of adversity. Answers are on a 5-point scale, not true at all=0, rarely true=1, sometimes true=2, often true=3, and true nearly all of the time=4. Higher scores indicating greater perceived resilience.	At study enrollment
Caregiver Preparedness: Preparedness for Caregiving Scale	The Preparedness for Caregiving Scale is a self-rated 10 item instrument that asks caregivers how well prepared they believe they are for multiple domains of care giving. Preparedness is defined as perceived readiness for multiple domains of the care giving role such as providing physical care, providing emotional support, setting up in-home support services, and dealing with the stress of care giving. Responses are rated on a 5-point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score the more prepared the caregiver feels for caregiving; the lower the score the less prepared the caregiver feels.	Within 48 hours of patient participant ICU discharge

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: Gordon and Betty Moore Foundation
• Investigators: Principal Investigator: Breanna Hetland, PhD, University of Nebraska

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being; Consumer Behavior
• Other Study ID Numbers: 0221-24-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: Yes
• product manufactured in and exported from the U.S.: No