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NCT Number: NCT07778004

ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their 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

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Key information

Conditions

Acute Respiratory Failure Critical Illness Disease Attributes Hypercapnia Hypoxia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Signs and Symptoms Signs and Symptoms, Respiratory Systemic Inflammatory Response Syndrome

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICU-SUCCEED

Behavioral

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 Care

Other

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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

Secondary outcomes

  1. Patients' Hospital Anxiety and Depression scores at Day 90

    Time frame: 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)

  2. Caregivers' Hospital Anxiety and Depression scores at Day 90

    Time frame: 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)

  3. Patients' Impact of Events Scale-6 scores at Day 90

    Time frame: 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

  4. Caregivers' Impact of Events Scale-6 scores at Day 90

    Time frame: 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

  5. Patients' return to work status at Day 90

    Time frame: 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

  6. Caregivers' return to work status at Day 90

    Time frame: 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

  7. Patients' EQ-5D scores at Day 90

    Time frame: 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.

  8. Caregivers' EQ-5D scores at Day 90

    Time frame: 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.

  9. Patients' Care Transition Measure scores at Day 90

    Time frame: 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.

  10. Caregivers' Care Transition Measure scores at Day 90

    Time frame: 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.

  11. Patients' Multidimensional Scale of Perceived Social Support scores at Day 90

    Time frame: 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.

  12. Caregivers' Multidimensional Scale of Perceived Social Support scores at Day 90

    Time frame: 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.

  13. Patients' Couples' Illness Communication Scale scores at Day 90

    Time frame: 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.

  14. Caregivers' Couples' Illness Communication Scale scores at Day 90

    Time frame: 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.

  15. Patients' Self-Care Self Efficacy Scale scores at Day 90

    Time frame: 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.

  16. Caregivers' Self-Care Self Efficacy Scale scores at Day 90

    Time frame: 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.

  17. Days alive and out of hospital (DAOH)

    Time frame: From enrollment to day 90 follow-up

    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.

  18. Patients' Self-Care Self Efficacy Scale scores at Baseline

    Time frame: 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.

  19. Caregivers' Self-Care Self Efficacy Scale scores at Baseline

    Time frame: 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.

  20. Patients' change in self-efficacy

    Time frame: Baseline to 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.

  21. Caregivers' change in self-efficacy

    Time frame: Baseline to Day 90

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Blair Wendlandt, MD, MSCR

CONTACT

[email protected]

(984)542-7702

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study 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

Acronym: ICU-SUCCEED

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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