What this study is
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
What's being tested
- ICU-SUCCEED
Intervention · 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
Intervention · 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.
Study details
- 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
- Sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Acute Respiratory Failure · Critical Illness · Sepsis · Hypoxia · Hypercapnia
- Enrolling
- 144 people
- Starts
- 2026-11-15
- Est. completion
- 2030-09-01
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 99 YearsSex ALLHealthy volunteers Not acceptedPatient
You may qualify if
- 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
You can't join if
- 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
You may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUNC Hospitals
Chapel Hill, North Carolina, United States
- Blair Wendlandt, MD, MSCR · Contact984-542-7702succeed_icu@med.unc.edu
Study team
Sponsor
University of North Carolina, Chapel Hill
Study ID 24-3010
Principal investigator
Blair Wendlandt, MD, MSCR
University of North Carolina, Chapel Hill
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.