Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT06463158
Status:
RECRUITING
Last Update Posted:
2025-04-27
First Post:
2024-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of the Family Room App on Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D003258', 'term': 'Consumer Behavior'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2024-06-04', 'studyFirstSubmitQcDate': '2024-06-11', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caregiver Engagement - Practical Aspects: FAMily Engagement (FAME) Tool', 'timeFrame': 'At study enrollment and within 48 hours of patient participant ICU discharge', 'description': '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.'}, {'measure': 'Daily Activity: Family Room Application', 'timeFrame': 'Daily from enrollment until patient participant ICU discharge, an average of 3 weeks', 'description': 'The daily activity logged in the Family Room application at bedside is assessed (intervention group only).'}, {'measure': 'Daily Patient Symptoms - Severity of Illness: Acute Physiology and Chronic Health Evaluation (Apache II)', 'timeFrame': 'Daily from enrollment until patient participant ICU discharge, an average of 3 weeks', 'description': '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.'}, {'measure': 'Daily Patient Symptoms: Presence of Lines, Tubes and Equipment', 'timeFrame': 'Daily from enrollment until patient participant ICU discharge, an average of 3 weeks', 'description': '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.'}, {'measure': 'Daily Patient Symptoms: Glasgow Coma Scale (GCS)', 'timeFrame': 'Daily from enrollment until patient participant ICU discharge, an average of 3 weeks', 'description': '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.'}, {'measure': 'Daily Patient Symptoms: Pain', 'timeFrame': 'Daily from enrollment until patient participant ICU discharge, an average of 3 weeks', 'description': '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.'}, {'measure': 'Daily Patient Symptoms: Richmond Agitation-Sedation Scale (RASS)', 'timeFrame': 'Daily from enrollment until patient participant ICU discharge, an average of 3 weeks', 'description': '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.'}, {'measure': 'Daily Patient Symptoms: Confusion Assessment Method for the ICU', 'timeFrame': 'Daily from enrollment until patient participant ICU discharge, an average of 3 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Caregiver Well-being: Screening Tool for Psychological Distress (STOP-D)', 'timeFrame': 'At study enrollment, every 48 hours while patient participant is in the ICU, and within 48 hours of patient participant ICU discharge', 'description': '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.'}, {'measure': 'Caregiver Well-being: Caregiver Self-Assessment Questionnaire', 'timeFrame': 'At study enrollment and within 48 hours of patient participant ICU discharge', 'description': '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.'}, {'measure': 'Caregiver Engagement - Psychological Experience: Caregiving Health Engagement Scale (CHE-s)', 'timeFrame': 'At study enrollment and within 48 hours of patient participant ICU discharge', 'description': "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."}, {'measure': 'Caregiver Resilience: Connor-Davidson Resilience Scale (CD-RISC2)', 'timeFrame': 'At study enrollment', 'description': '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.'}, {'measure': 'Caregiver Preparedness: Preparedness for Caregiving Scale', 'timeFrame': 'Within 48 hours of patient participant ICU discharge', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Well-Being, Psychological', 'Engagement', 'Satisfaction, Consumer']}, 'referencesModule': {'references': [{'pmid': '27984278', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34904483', 'type': 'BACKGROUND', 'citation': 'Hetland 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.'}, {'pmid': '27878937', 'type': 'BACKGROUND', 'citation': 'Olding 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.'}, {'pmid': '30245366', 'type': 'BACKGROUND', 'citation': 'Kleinpell 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.'}, {'pmid': '31567354', 'type': 'BACKGROUND', 'citation': 'Kleinpell 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.'}, {'pmid': '28592476', 'type': 'BACKGROUND', 'citation': 'Hetland 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.'}, {'pmid': '35649201', 'type': 'BACKGROUND', 'citation': 'Hetland BD, McAndrew NS, Kupzyk KA, Krutsinger DC, Turnbull AE, Pozehl BJ, Heusinkvelt JM. 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No abstract available."}, {'pmid': '36444373', 'type': 'BACKGROUND', 'citation': 'Goldfarb M, Debigare S, Foster N, Soboleva N, Desrochers F, Craigie L, Burns KEA. Development of a Family Engagement Measure for the Intensive Care Unit. CJC Open. 2022 Aug 5;4(11):1006-1011. doi: 10.1016/j.cjco.2022.07.015. eCollection 2022 Nov.'}, {'pmid': '27287964', 'type': 'BACKGROUND', 'citation': 'Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.'}, {'pmid': '33089659', 'type': 'BACKGROUND', 'citation': 'McAndrew NS, Jerofke-Owen T, Fortney CA, Costa DK, Hetland B, Guttormson J, Harding E. Systematic review of family engagement interventions in neonatal, paediatric, and adult ICUs. Nurs Crit Care. 2022 May;27(3):296-325. doi: 10.1111/nicc.12564. Epub 2020 Oct 21.'}, {'type': 'BACKGROUND', 'citation': 'Hetland BD, Pozehl B, Kupzyk K, et al. The impact of family caregiver psychophysiological characteristics on the caregiver role in the intensive care unit. Am J Respir Crit Care Med. https://doi.org/10.1164/ajrccmconference.2019.199.1_MeetingAbstracts.A4361'}, {'type': 'BACKGROUND', 'citation': 'Hetland B, Bach C, Castner JP, et al. A randomized clinical trial to test a mobile application that supports family caregiver participation in patient care in the intensive care unit. Am J Respir Crit Care Med. 2023;207:A2507.'}, {'type': 'BACKGROUND', 'citation': 'Hetland B, Bach C, Grotts E, et al. Development of a Mobile Application to Promote Family Caregiver Engagement in the Assessment and Management of Patient Symptoms During Mechanical Ventilation in the Intensive Care Unit (ICU). Am J Respir Crit Care Med. 2021;203:A1090.'}, {'type': 'BACKGROUND', 'citation': 'Wilk, C. Development and Psychometric Performance of the Family Willingness for Caregiving Scale (FWCS). [Doctoral dissertation]. Kent, OH: Kent State; 2023.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nDuring 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.\n\nData 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 19 years of age or older\n* Present at participant's bedside during the intensive care unit (ICU) admission\n* Participant's legally authorized representative (LAR) or designated caregiver to make medical decisions on their behalf\n\nExclusion Criteria:\n\n• Not legally authorized representative (LAR) or designated caregiver to make medical decisions on their behalf"}, 'identificationModule': {'nctId': 'NCT06463158', 'briefTitle': 'The Impact of the Family Room App on Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '0221-24-EP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group - No Intervention', 'description': '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.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group - Family Room Application', 'description': '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.', 'interventionNames': ['Device: Family Room Application']}], 'interventions': [{'name': 'Family Room Application', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Intervention Group - Family Room Application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Breanna Hetland, PhD', 'role': 'CONTACT', 'email': 'breanna.hetland@unmc.edu', 'phone': '402-559-5460'}], 'facility': 'Nebraska Medicine', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Breanna Hetland, PhD', 'role': 'CONTACT', 'email': 'breanna.hetland@unmc.edu', 'phone': '309-231-4537'}, {'name': 'Taelyr Weekly, PhD', 'role': 'CONTACT', 'email': 'tweekly@childrensnebraska.org', 'phone': '402-690-7706'}], 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'centralContacts': [{'name': 'Breanna Hetland, PhD', 'role': 'CONTACT', 'email': 'breanna.hetland@unmc.edu', 'phone': '309-231-4537'}], 'overallOfficials': [{'name': 'Breanna Hetland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gordon and Betty Moore Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}