Recruiting

Observational Study

Sponsor:

University of Nebraska

Code:

NCT06463158

Conditions

Well-Being, Psychological

Engagement

Satisfaction, Consumer

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Interventions

Family Room Application

Study Details

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

Study ID

NCT06463158

Start date

Jul 1, 2024

Status verified date

Aug, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Caregiver Engagement - Practical Aspects: FAMily Engagement (FAME) Tool [ Time Frame: At study enrollment and within 48 hours of patient participant ICU discharge ]
  • Daily Activity: Family Room Application [ Time Frame: 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) [ Time Frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks ]
  • Daily Patient Symptoms: Presence of Lines, Tubes and Equipment [ Time Frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks ]
  • Daily Patient Symptoms: Glasgow Coma Scale (GCS) [ Time Frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks ]
  • Daily Patient Symptoms: Pain [ Time Frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks ]
  • Daily Patient Symptoms: Richmond Agitation-Sedation Scale (RASS) [ Time Frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks ]
  • Daily Patient Symptoms: Confusion Assessment Method for the ICU [ Time Frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks ]

Central Contacts and Locations

Central contacts

Breanna Hetland, PhD

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

Locations

Nebraska Medicine

Recruiting

Omaha, Nebraska, United States, 68105

Contacts

Breanna Hetland, PhD

402-559-5460breanna.hetland@unmc.edu

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Breanna Hetland, PhD

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

Taelyr Weekly, PhD

402-690-7706tweekly@childrensnebraska.org

More Information

Sponsor

University of Nebraska

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-08-28.