Acute Respiratory FailureICU-SUCCEEDNCT07778004
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
A study testing ICU-SUCCEED in people with Acute Respiratory Failure and Critical Illness, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Respiratory Failure, Critical Illness, Sepsis
- What is being tested?
- ICU-SUCCEED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2026to 1 Sep 2030
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Patient Inclusion Criteria
- Admitted to the medical ICU at UNC with acute respiratory failure (functional lung impairment resulting in hypoxia, hypercapnia, or both) and/or sepsis with significant end organ dysfunction.
- At least 18 years old
- Survives to hospital discharge
- Is expected to be discharged home or to an acute inpatient rehabilitation center with a clear plan to be subsequently discharged home
- Capable of providing written informed consent
- Has English language proficiency
Caregiver Inclusion Criteria
- Provides emotional, physical, and/or financial support to the patient in a non-professional, unpaid capacity
- Must be related to the patient in one of the following ways: a spouse or domestic partner, an adult child, a parent, or a sibling
- At least 18 years of age
- Has English language proficiency
- Must be the caregiver of a patient that meets the patient eligibility criteria listed above
Patient Exclusion Criteria:
- No available family caregiver
- Lacks decision-making capacity
- Under 18 years of age
- Living at a location other than home prior to admission
- Unhoused prior to admission
- Receives extracorporeal membrane oxygenation (ECMO) during hospital stay
- Expected to discharge to any location other than home or an acute inpatient rehabilitation center
- Does not have English language proficiency
Caregiver Exclusion Criteria
- Does not provide emotional, physical, and/or financial support to the patient in a non-profession, unpaid capacity
- Is not related to the patient in one of the following ways: a spouse or domestic partner, an adult child, a parent, or a sibling
- Cannot complete surveys or engage in other study activities due to physical or cognitive limitations
- Unhoused prior to admission
- Is under 18 years of age
- Does not have English language proficiency
- Is not the caregiver of a patient that meets the patient eligibility criteria listed above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UNC Hospitals
Chapel Hill, North Carolina, 27599
Blair Wendlandt, MD, MSCR, 984-542-7702, succeed_icu@med.unc.edu
About this study
Official title: A Pilot Randomized Trial of the Self-Management Using Couples' Coping EnhancEment in Diseases Intervention for Survivors of Acute Respiratory Failure and Their Family Caregivers
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
Read the detailed description
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.
- Conditions
- Acute Respiratory Failure, Critical Illness, Sepsis, Hypoxia, Hypercapnia
- Being tested
- ICU-SUCCEED, Augmented Usual Care
- Keywords
- Acute Respiratory Failure, Family-Centered Intervention, Critical illness, Sepsis, Septic shock
- Medical subject headings
- Critical Illness, Sepsis, Hypoxia, Hypercapnia, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU-SUCCEEDBehavioural
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
Augmented Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ICU-SUCCEED | Experimental | This arm will receive ICU-SUCCEED intervention. Receives: Behavioral: ICU-SUCCEED |
| Augmented Usual Care | Placebo comparator | This arm will receive standard care routinely available plus written handouts prior to hospital discharge. Receives: Other: Augmented Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Day 90
Secondary outcomes (21)
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start15 Nov 2026 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Blair Wendlandt, MD, MSCR, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778004
- Sponsor's protocol ID
- 24-3010
- Other IDs
- 1K23HL171951-01A1
- Acronym
- ICU-SUCCEED
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial of the Self-Management Using Couples' Coping EnhancEment in Diseases Intervention for Survivors of Acute Respiratory Failure and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT07778004
- Acronym / sponsor ID
- ICU-SUCCEED / 24-3010
- Conditions
- Acute Respiratory Failure, Critical Illness, Sepsis, Hypoxia, Hypercapnia
- Keywords
- Acute Respiratory Failure, Family-Centered Intervention, Critical illness, Sepsis, Septic shock
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 21 Aug 2026 (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.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU-SUCCEED | Experimental | Behavioral: ICU-SUCCEEDThis arm will receive ICU-SUCCEED intervention. |
| Augmented Usual Care | Placebo comparator | Other: Augmented Usual CareThis arm will receive standard care routinely available plus written handouts prior to hospital discharge. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ICU-SUCCEEDIncludes 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 | Behavioural | ICU-SUCCEED |
| Augmented Usual CareUsual 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. | Other | Augmented Usual Care |
Primary outcome
Feasibility of participant eligibility
Time frame: From the start to the end of recruitment
Defined as the number of patients who met the inclusion criteria relative to the number of patients screened. Expressed as a percentage.
Feasibility of recruitment
Time frame: From the start to the end 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
Feasibility of enrollment
Time frame: From the start to end of recruitment
The number of enrolled dyads who provide consent relative to the number of dyads that are approached. Expressed as a percentage
Feasibility of ICU-SUCCEED inpatient session
Time frame: From recruitment start to inpatient session completion
The number of dyads who complete inpatient session relative to the number of participants randomized to the intervention arm. Expressed as a percentage.
Feasibility of intervention completion
Time frame: From enrollment through intervention completion, average of 8 weeks
The number of dyads that complete all five sessions relative to the number of dyads randomized. Expressed as a percentage.
Feasibility of retention
Time frame: From enrollment to day 90 follow-up
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.
Intervention acceptability
Time frame: Day 90
Defined as the mean score on three Likert-scale items assessed at 90 days post index discharge for participants in the intervention group
21 secondary outcomes
Patients' Hospital Anxiety and Depression scores at Day 90
Time frame: Day 90
Caregivers' Hospital Anxiety and Depression scores at Day 90
Time frame: Day 90
Patients' Impact of Events Scale-6 scores at Day 90
Time frame: Day 90
Caregivers' Impact of Events Scale-6 scores at Day 90
Time frame: Day 90
Patients' return to work status at Day 90
Time frame: Day 90
Caregivers' return to work status at Day 90
Time frame: Day 90
Patients' EQ-5D scores at Day 90
Time frame: Day 90
Caregivers' EQ-5D scores at Day 90
Time frame: Day 90
Patients' Care Transition Measure scores at Day 90
Time frame: Day 90
Caregivers' Care Transition Measure scores at Day 90
Time frame: Day 90
Patients' Multidimensional Scale of Perceived Social Support scores at Day 90
Time frame: Day 90
Caregivers' Multidimensional Scale of Perceived Social Support scores at Day 90
Time frame: Day 90
Patients' Couples' Illness Communication Scale scores at Day 90
Time frame: Day 90
Caregivers' Couples' Illness Communication Scale scores at Day 90
Time frame: Day 90
Patients' Self-Care Self Efficacy Scale scores at Day 90
Time frame: Day 90
Caregivers' Self-Care Self Efficacy Scale scores at Day 90
Time frame: Day 90
Days alive and out of hospital (DAOH)
Time frame: From enrollment to day 90 follow-up
Patients' Self-Care Self Efficacy Scale scores at Baseline
Time frame: Baseline
Caregivers' Self-Care Self Efficacy Scale scores at Baseline
Time frame: Baseline
Patients' change in self-efficacy
Time frame: Baseline to Day 90
Caregivers' change in self-efficacy
Time frame: Baseline to Day 90
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 5 Nov 2026.
- Individual participant dataSharing planned: 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.
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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.
Blair Wendlandt, MD, MSCR principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICU-SUCCEED in people with Acute Respiratory Failure and Critical Illness, run by University of North Carolina, Chapel Hill at 1 site 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?
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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 Blair Wendlandt, MD, MSCR ((984)542-7702, succeed_icu@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of participant eligibility (time frame: From the start to the end of recruitment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.