An interventional study of ICU-SUCCEED and Augmented Usual Care in Acute Respiratory Failure, Critical Illness and Sepsis, sponsored by University of North Carolina, Chapel Hill. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Supportive care
This study will investigate whether a family-centered intervention that has been adapted for patients with critical illness and their caregivers is possible, acceptable, and helpful
Participants will be randomized to receive written handouts or to the ICU-SUCCEED intervention. The intervention includes one inpatient (in-person) and 4 outpatient (Zoom or telephone) sessions that take 30-45 minutes. Dyads will complete questionnaires at baseline and at a Day 90 Follow-Up.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 144 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Compared within Sepsis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patient Inclusion Criteria
Caregiver Inclusion Criteria
Patient Exclusion Criteria:
Caregiver Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm will receive ICU-SUCCEED intervention.
Behavioral: ICU-SUCCEED
This arm will receive standard care routinely available plus written handouts prior to hospital discharge.
Other: Augmented Usual Care
Includes one inpatient (in-person) session followed by four outpatient (Zoom or telephone) sessions. Dyads will receive one session every 1-2 weeks. Each session will have a different focus, which may incorporate one of the following: communication, self-management, emotion management, stress management, lifestyle and hobbies, and interpersonal relationship building. This intervention has been adapted to meet the needs of patients with acute respiratory failure and their caregivers
Usual care will continue unchanged and will include any services, counseling, monitoring, or referrals that are coordinated by the clinical team prior to discharge. Handouts include a hospital discharge preparation checklist and information about the long-term complications of and recovery from critical illness.
Feasibility of participant eligibility
Defined as the number of patients who met the inclusion criteria relative to the number of patients screened. Expressed as a percentage.
Time frame: From the start to the end of recruitment
Feasibility of recruitment
The number of eligible patient-caregiver dyads that are approached by the study team relative to the number of dyads that are eligible for the study. Expressed as a percentage
Time frame: From the start to the end of recruitment
Feasibility of enrollment
The number of enrolled dyads who provide consent relative to the number of dyads that are approached. Expressed as a percentage
Time frame: From the start to end of recruitment
Feasibility of ICU-SUCCEED inpatient session
The number of dyads who complete inpatient session relative to the number of participants randomized to the intervention arm. Expressed as a percentage.
Time frame: From recruitment start to inpatient session completion
Feasibility of intervention completion
The number of dyads that complete all five sessions relative to the number of dyads randomized. Expressed as a percentage.
Time frame: From enrollment through intervention completion, average of 8 weeks
Feasibility of retention
The number of dyads who remained in the study through the Day 90 Follow-up relative to the number of dyads that are consented. Expressed as a percentage.
Time frame: From enrollment to day 90 follow-up
Intervention acceptability
Defined as the mean score on three Likert-scale items assessed at 90 days post index discharge for participants in the intervention group
Time frame: Day 90
Patients' Hospital Anxiety and Depression scores at Day 90
Defined as the difference between the intervention and control arms on the Hospital Anxiety and Depression scale, which is designed to measure severity of anxiety and depression over the past week. Scores range from 0 to 21 where higher scores indicate greater anxiety and depression)
Time frame: Day 90
Caregivers' Hospital Anxiety and Depression scores at Day 90
Defined as the difference between the intervention and control arms on the Hospital Anxiety and Depression scale which is designed to measure severity of anxiety and depression over the past week. Scores range from 0 to 21 where higher scores indicate greater anxiety and depression)
Time frame: Day 90
Patients' Impact of Events Scale-6 scores at Day 90
The difference in scores between the intervention and control arms on the Impact of Events Scale-6, which is designed to measure symptoms of post-traumatic stress disorder. Scores range from 0 to 24 where higher scores indicate greater impairment
Time frame: Day 90
Caregivers' Impact of Events Scale-6 scores at Day 90
The difference in scores between the intervention and control arms on the Impact of Events Scale-6 which is designed to measure symptoms of post-traumatic stress disorder. Scores range from 0 to 24 where higher scores indicate greater impairment
Time frame: Day 90
Patients' return to work status at Day 90
The difference between arms in the proportion of patients who have returned to work as defined by a Y/N item on a revised Employment Questionnaire
Time frame: Day 90
Caregivers' return to work status at Day 90
The difference between arms in the proportion of caregivers who have returned to work as defined by a Y/N item on a revised Employment Questionnaire
Time frame: Day 90
Patients' EQ-5D scores at Day 90
The difference in scores between the intervention and control arms on the EQ-5D, which measures health-related quality of life. Scores range from 5 to 25 where higher scores indicate worse health status.
Time frame: Day 90
Caregivers' EQ-5D scores at Day 90
The difference in scores between the intervention and control arms on the EQ-5D which measures health-related quality of life. Scores range from 5 to 25 where higher scores indicate worse health status.
Time frame: Day 90
Patients' Care Transition Measure scores at Day 90
The difference in scores between the intervention and control arms on the Care Transition Measure, which measures an individual's preparation for hospital discharge. Scores range from 3 to 13 where higher scores indicate greater preparation for hospital discharge.
Time frame: Day 90
Caregivers' Care Transition Measure scores at Day 90
The difference in scores between the intervention and control arms on the Care Transition Measure which measures an individual's preparation for hospital discharge. Scores range from 3 to 13 where higher scores indicate greater preparation for hospital discharge.
Time frame: Day 90
Patients' Multidimensional Scale of Perceived Social Support scores at Day 90
The difference in scores between the intervention and control arms on the Multidimensional Scale of Perceived Social Support, which measures perceived social support. Scores range from 12 to 84 where higher scores indicate greater perceived support.
Time frame: Day 90
Caregivers' Multidimensional Scale of Perceived Social Support scores at Day 90
The difference in scores between the intervention and control arms on the Multidimensional Scale of Perceived Social Support which measures perceived social support. Scores range from 12 to 84 where higher scores indicate greater perceived support.
Time frame: Day 90
Patients' Couples' Illness Communication Scale scores at Day 90
The difference in scores between the intervention and control arms on the Couples' Illness Communication Scale, which measures a couple's illness-related communication. Scores range from 4 to 20 where higher scores indicate greater communication.
Time frame: Day 90
Caregivers' Couples' Illness Communication Scale scores at Day 90
The difference in scores between the intervention and control arms on the Couples' Illness Communication Scale which measures a couple's illness-related communication. Scores range from 4 to 20 where higher scores indicate greater communication.
Time frame: Day 90
Patients' Self-Care Self Efficacy Scale scores at Day 90
The difference in scores between the intervention and control arms on the Self-Care Self Efficacy Scale, which measures a patient's confidence in completing activities related to their self-care. Scores range from 10 to 50 where higher scores indicate greater self-efficacy.
Time frame: Day 90
Caregivers' Self-Care Self Efficacy Scale scores at Day 90
The difference in scores between the intervention and control arms on the Caregiver Self-Efficacy in Contribution to Self-Care Scale, which measures a caregiver's confidence in supporting a patient in completing activities related to the patient's self-care. Scores range from 10 to 50 where higher scores indicate greater self-efficacy.
Time frame: Day 90
Days alive and out of hospital (DAOH)
Defined as the number of days spent alive and outside of an acute care hospital (including acute care at home), long-term acute care hospital (LTACH), or emergency department (ED) over the 90 days following index hospital discharge.
Time frame: From enrollment to day 90 follow-up
Patients' Self-Care Self Efficacy Scale scores at Baseline
The difference in scores between the intervention and control arms on the Self-Care Self Efficacy Scale, which measures a patient's confidence in completing activities related to their self-care. Scores range from 10 to 50 where higher scores indicate greater self-efficacy.
Time frame: Baseline
Caregivers' Self-Care Self Efficacy Scale scores at Baseline
The difference in scores between the intervention and control arms on the Self-Care Self Efficacy Scale which measures a caregiver's confidence in supporting a patient in completing activities related to the patient's self-care. Scores range from 10 to 50 where higher scores indicate greater self-efficacy.
Time frame: Baseline
Patients' change in self-efficacy
The difference in scores between the intervention and control arms on the Self-Care Self Efficacy Scale, which measures a patient's confidence in completing activities related to their self-care. Scores range from 10 to 50 where higher scores indicate greater self-efficacy.
Time frame: Baseline to Day 90
Caregivers' change in self-efficacy
The difference in scores between the intervention and control arms on the Self-Care Self Efficacy Scale which measures a caregiver's confidence in supporting a patient in completing activities related to the patient's self-care. Scores range from 10 to 50 where higher scores indicate greater self-efficacy.
Time frame: Baseline to Day 90
Plan to share: Yes — Deidentified individual data that supports the results may be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting information: Study protocol
Time frame: beginning 9 and continuing for 36 months following publication
Access criteria: The investigator who proposes to use the data must have an approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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