Understanding recovery expectations in acute respiratory failure survivors and their caregivers
Investigating Dyadic Expectations About ARF Survivorship (IDEAS)
Johns Hopkins University · NCT06401239
This study looks at how adults who survive acute respiratory failure and their caregivers feel about recovery in the first six months after leaving the hospital to see if shared expectations can help improve their mental health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 235 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06401239 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how adults who survive acute respiratory failure (ARF) and their caregivers perceive the recovery process during the first six months post-discharge. Participants will complete three surveys that assess their expectations, feelings, and mental health symptoms. The study aims to explore the relationship between shared expectations within survivor-care partner dyads and their coping strategies. By analyzing these dynamics, the research seeks to identify factors that may improve mental health outcomes for both survivors and their caregivers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have survived acute respiratory failure and can identify a primary caregiver.
Not a fit: Patients with pre-existing cognitive impairments or those residing in medical institutions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the mental health and coping strategies of ARF survivors and their caregivers.
How similar studies have performed: Other studies have shown success in exploring dyadic coping and mental health outcomes in similar patient populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Patient Inclusion Criteria:
* ≥18 years old
* Meets study definition of ARF:
* The study defines ARF as meeting 1 of the following 3:
1. Mechanical ventilation via an endotracheal tube ≥24 consecutive hours OR
2. Non-invasive ventilation (CPAP, BiPAP) ≥24 consecutive hours that is not for obstructive sleep apnea or other stable use OR
3. High flow nasal cannula with fraction of inspired oxygen (FIO2)≥.5 and flow rate ≥ litres per minute (LPM) for ≥24 consecutive hours.
* Occasional rest periods of ≤1 hour are not deducted from the calculation of consecutive hours. Patients who are intubated for mental status or airway obstruction are not eligible unless they have simultaneous ARF.
* Survival to hospital discharge to home
* Speaks or reads English or Spanish
* Identifies an adult who is expected to act as a primary care partner for at least the next 6 months.
Patient Exclusion Criteria:
* Pre-existing cognitive impairment (IQ-CODE \>3.6)
* Residing in a medical institution at hospital discharge
* Receiving hospice care or life expectancy \<6 months
* Homelessness or recent history of psychosis
Care Partner Inclusion Criteria:
* ≥18 years old
* Speaks or reads English or Spanish
Care Partner Exclusion Criteria:
* Pre-existing cognitive impairment (IQ-CODE \>3.6)
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Ann M Parker, MD, PhD — Johns Hopkins University
- Study coordinator: Ann M Parker, MD, PhD
- Email: ann.parker@jhmi.edu
- Phone: 410-955-2190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Respiratory Failure, Caregiving Stress, Mental Health Issue, ARF survivor, Caregiver, ICU recovery, Dyadic coping, Dyadic self-efficacy