Well-Being, PsychologicalNCT06463158
The Impact of the Family Room App on Caregivers
A study testing Family Room Application in people with Well-Being, Psychological and Engagement, run by University of Nebraska at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological, Engagement, Satisfaction, Consumer
- What is being tested?
- Family Room Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not legally authorized representative (LAR) or designated caregiver to make medical decisions on their behalf
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Nebraska Medicine
Omaha, Nebraska, 68105
Breanna Hetland, PhD, 402-559-5460, breanna.hetland@unmc.edu
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Breanna Hetland, PhD, 309-231-4537, breanna.hetland@unmc.edu
Taelyr Weekly, PhD, 402-690-7706, tweekly@childrensnebraska.org
About this study
Official title: 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.
Read the 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.
- Being tested
- Family Room Application
- Medical subject headings
- Psychological Well-Being, Consumer Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Room ApplicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Family Room Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 48 hours of patient participant ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jul 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Responsible party
- Sponsor
- Investigators
- Breanna Hetland, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463158
- Sponsor's protocol ID
- 0221-24-EP
- Status last verified
- Aug 2026
- First submitted
- 4 Jun 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.
PubMed 27984278Hetland BD, McAndrew NS, Kupzyk KA, Krutsinger DC, Pozehl BJ, Heusinkvelt JM, Camenzind CE. Family Caregiver Preferences and Contributions Related to Patient Care in the ICU. West J Nurs Res. 2022 Mar;44(3):214-226. doi: 10.1177/01939459211062954. Epub 2021 Dec 14.
PubMed 34904483Olding M, McMillan SE, Reeves S, Schmitt MH, Puntillo K, Kitto S. Patient and family involvement in adult critical and intensive care settings: a scoping review. Health Expect. 2016 Dec;19(6):1183-1202. doi: 10.1111/hex.12402. Epub 2015 Sep 7.
PubMed 27878937Kleinpell R, Heyland DK, Lipman J, Sprung CL, Levy M, Mer M, Koh Y, Davidson J, Taha A, Curtis JR; Council of the World Federation of Societies of Intensive and Critical Care Medicine. Patient and family engagement in the ICU: Report from the task force of the World Federation of Societies of Intensive and Critical Care Medicine. J Crit Care. 2018 Dec;48:251-256. doi: 10.1016/j.jcrc.2018.09.006. Epub 2018 Sep 8.
PubMed 30245366Kleinpell R, Zimmerman J, Vermoch KL, Harmon LA, Vondracek H, Hamilton R, Hanson B, Hwang DY. Promoting Family Engagement in the ICU: Experience From a National Collaborative of 63 ICUs. Crit Care Med. 2019 Dec;47(12):1692-1698. doi: 10.1097/CCM.0000000000004009.
PubMed 31567354Hetland B, Hickman R, McAndrew N, Daly B. Factors Influencing Active Family Engagement in Care Among Critical Care Nurses. AACN Adv Crit Care. 2017 Summer;28(2):160-170. doi: 10.4037/aacnacc2017118.
PubMed 28592476Hetland BD, McAndrew NS, Kupzyk KA, Krutsinger DC, Turnbull AE, Pozehl BJ, Heusinkvelt JM. Relationships among Demographic, Clinical, and Psychological Factors Associated with Family Caregiver Readiness to Participate in Intensive Care Unit Care. Ann Am Thorac Soc. 2022 Nov;19(11):1881-1891. doi: 10.1513/AnnalsATS.202106-651OC.
PubMed 35649201Hetland B, McAndrew N, Perazzo J, Hickman R. A qualitative study of factors that influence active family involvement with patient care in the ICU: Survey of critical care nurses. Intensive Crit Care Nurs. 2018 Feb;44:67-75. doi: 10.1016/j.iccn.2017.08.008. Epub 2017 Nov 21.
PubMed 29169879Tracy MF, Chlan L. Nonpharmacological interventions to manage common symptoms in patients receiving mechanical ventilation. Crit Care Nurse. 2011 Jun;31(3):19-28. doi: 10.4037/ccn2011653.
PubMed 21632591Puntillo KA, Arai S, Cohen NH, Gropper MA, Neuhaus J, Paul SM, Miaskowski C. Symptoms experienced by intensive care unit patients at high risk of dying. Crit Care Med. 2010 Nov;38(11):2155-60. doi: 10.1097/CCM.0b013e3181f267ee.
PubMed 20711069Mitchell M, Chaboyer W, Burmeister E, Foster M. Positive effects of a nursing intervention on family-centered care in adult critical care. Am J Crit Care. 2009 Nov;18(6):543-52; quiz 553. doi: 10.4037/ajcc2009226.
PubMed 19880956Mitchell ML, Kean S, Rattray JE, Hull AM, Davis C, Murfield JE, Aitken LM. A family intervention to reduce delirium in hospitalised ICU patients: A feasibility randomised controlled trial. Intensive Crit Care Nurs. 2017 Jun;40:77-84. doi: 10.1016/j.iccn.2017.01.001. Epub 2017 Feb 27.
PubMed 28254205Blom H, Gustavsson C, Sundler AJ. Participation and support in intensive care as experienced by close relatives of patients: a phenomenological study. Intensive Crit Care Nurs. 2013 Feb;29(1):1-8. doi: 10.1016/j.iccn.2012.04.002. Epub 2012 Jun 28.
PubMed 22748280Puntillo K, Arai SR, Cooper BA, Stotts NA, Nelson JE. A randomized clinical trial of an intervention to relieve thirst and dry mouth in intensive care unit patients. Intensive Care Med. 2014 Sep;40(9):1295-302. doi: 10.1007/s00134-014-3339-z. Epub 2014 Jun 4.
PubMed 24894026Yen PY, Kellye M, Lopetegui M, Saha A, Loversidge J, Chipps EM, Gallagher-Ford L, Buck J. Nurses' Time Allocation and Multitasking of Nursing Activities: A Time Motion Study. AMIA Annu Symp Proc. 2018 Dec 5;2018:1137-1146. eCollection 2018.
PubMed 30815156
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06463158
- Acronym / sponsor ID
- 0221-24-EP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Family Room ApplicationDuring the last 10 months, participants will be enrolled into the intervention group where they will use the Family Room application on their personal devices. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Not legally authorized representative (LAR) or designated caregiver to make medical decisions on their behalf
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Room ApplicationThe 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. | Device | Intervention Group - Family Room Application |
Primary outcome
Caregiver Engagement - Practical Aspects: FAMily Engagement (FAME) Tool
Time frame: At study enrollment and within 48 hours of patient participant ICU discharge
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.
Daily Activity: Family Room Application
Time frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
The daily activity logged in the Family Room application at bedside is assessed (intervention group only).
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
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 Patient Symptoms: Presence of Lines, Tubes and Equipment
Time frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
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 Patient Symptoms: Glasgow Coma Scale (GCS)
Time frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
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 Patient Symptoms: Pain
Time frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
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 Patient Symptoms: Richmond Agitation-Sedation Scale (RASS)
Time frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
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 Patient Symptoms: Confusion Assessment Method for the ICU
Time frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
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.
5 secondary outcomes
Caregiver Well-being: Screening Tool for Psychological Distress (STOP-D)
Time frame: 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
Time frame: At study enrollment and within 48 hours of patient participant ICU discharge
Caregiver Engagement - Psychological Experience: Caregiving Health Engagement Scale (CHE-s)
Time frame: At study enrollment and within 48 hours of patient participant ICU discharge
Caregiver Resilience: Connor-Davidson Resilience Scale (CD-RISC2)
Time frame: At study enrollment
Caregiver Preparedness: Preparedness for Caregiving Scale
Time frame: Within 48 hours of patient participant ICU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background: PubMed 27984278Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.
- Background: PubMed 34904483Hetland BD, McAndrew NS, Kupzyk KA, Krutsinger DC, Pozehl BJ, Heusinkvelt JM, Camenzind CE. Family Caregiver Preferences and Contributions Related to Patient Care in the ICU. West J Nurs Res. 2022 Mar;44(3):214-226. doi: 10.1177/01939459211062954. Epub 2021 Dec 14.
- Background: PubMed 27878937Olding M, McMillan SE, Reeves S, Schmitt MH, Puntillo K, Kitto S. Patient and family involvement in adult critical and intensive care settings: a scoping review. Health Expect. 2016 Dec;19(6):1183-1202. doi: 10.1111/hex.12402. Epub 2015 Sep 7.
- Background: PubMed 30245366Kleinpell R, Heyland DK, Lipman J, Sprung CL, Levy M, Mer M, Koh Y, Davidson J, Taha A, Curtis JR; Council of the World Federation of Societies of Intensive and Critical Care Medicine. Patient and family engagement in the ICU: Report from the task force of the World Federation of Societies of Intensive and Critical Care Medicine. J Crit Care. 2018 Dec;48:251-256. doi: 10.1016/j.jcrc.2018.09.006. Epub 2018 Sep 8.
- Background: PubMed 31567354Kleinpell R, Zimmerman J, Vermoch KL, Harmon LA, Vondracek H, Hamilton R, Hanson B, Hwang DY. Promoting Family Engagement in the ICU: Experience From a National Collaborative of 63 ICUs. Crit Care Med. 2019 Dec;47(12):1692-1698. doi: 10.1097/CCM.0000000000004009.
- Background: PubMed 28592476Hetland B, Hickman R, McAndrew N, Daly B. Factors Influencing Active Family Engagement in Care Among Critical Care Nurses. AACN Adv Crit Care. 2017 Summer;28(2):160-170. doi: 10.4037/aacnacc2017118.
- Background: PubMed 35649201Hetland BD, McAndrew NS, Kupzyk KA, Krutsinger DC, Turnbull AE, Pozehl BJ, Heusinkvelt JM. Relationships among Demographic, Clinical, and Psychological Factors Associated with Family Caregiver Readiness to Participate in Intensive Care Unit Care. Ann Am Thorac Soc. 2022 Nov;19(11):1881-1891. doi: 10.1513/AnnalsATS.202106-651OC.
- Background: PubMed 29169879Hetland B, McAndrew N, Perazzo J, Hickman R. A qualitative study of factors that influence active family involvement with patient care in the ICU: Survey of critical care nurses. Intensive Crit Care Nurs. 2018 Feb;44:67-75. doi: 10.1016/j.iccn.2017.08.008. Epub 2017 Nov 21.
- Background: PubMed 21632591Tracy MF, Chlan L. Nonpharmacological interventions to manage common symptoms in patients receiving mechanical ventilation. Crit Care Nurse. 2011 Jun;31(3):19-28. doi: 10.4037/ccn2011653.
- Background: PubMed 20711069Puntillo KA, Arai S, Cohen NH, Gropper MA, Neuhaus J, Paul SM, Miaskowski C. Symptoms experienced by intensive care unit patients at high risk of dying. Crit Care Med. 2010 Nov;38(11):2155-60. doi: 10.1097/CCM.0b013e3181f267ee.
- Background: PubMed 19880956Mitchell M, Chaboyer W, Burmeister E, Foster M. Positive effects of a nursing intervention on family-centered care in adult critical care. Am J Crit Care. 2009 Nov;18(6):543-52; quiz 553. doi: 10.4037/ajcc2009226.
- Background: PubMed 28254205Mitchell ML, Kean S, Rattray JE, Hull AM, Davis C, Murfield JE, Aitken LM. A family intervention to reduce delirium in hospitalised ICU patients: A feasibility randomised controlled trial. Intensive Crit Care Nurs. 2017 Jun;40:77-84. doi: 10.1016/j.iccn.2017.01.001. Epub 2017 Feb 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Breanna Hetland, PhD principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Room Application in people with Well-Being, Psychological and Engagement, run by University of Nebraska at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Breanna Hetland, PhD (309-231-4537, breanna.hetland@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06463158, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.