Health TrialsbyHealthPanel

ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers

ConditionsAcute Respiratory FailureCritical IllnessSepsisHypoxiaHypercapnia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

No available family caregiver

Lacks decision-making capacity

Under 18 years of age

Living at a location other than home prior to admission

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: ICU-SUCCEEDExperimental treatment 1 intervention
Group B: Augmented Usual CarePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: