NCT06401239 Investigating Dyadic Expectations About ARF Survivorship (IDEAS)
| NCT ID | NCT06401239 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Acute Respiratory Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 235 participants |
| Start Date | 2024-07-23 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 235 participants in total. It began in 2024-07-23 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this observational study is to understand how adults who survive acute respiratory failure (ARF) and the people (usually family) who support ARF survivors after returning home think about the first 6 months of recovery. The study aims to find out if expectations about the recovery process after ARF are associated with mental health symptoms in both survivors and the survivor's care partners. Study participants will complete 3 surveys over 6 months. These surveys ask questions about participants' future expectations, feelings, and mood. Surveys can be completed online, over the phone, or on paper.
Eligibility 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)
Contact & Investigator
Ann M Parker, MD, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06401239 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06401239 currently recruiting?
Yes, NCT06401239 is actively recruiting participants. Contact the research team at ann.parker@jhmi.edu for enrollment information.
Where is the NCT06401239 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06401239 clinical trial?
NCT06401239 is sponsored by Johns Hopkins University. The principal investigator is Ann M Parker, MD, PhD at Johns Hopkins University. The trial plans to enroll 235 participants.