Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT06401239

Conditions

Acute Respiratory Failure

Caregiving Stress

Mental Health Issue

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dyadic expectations about the ARF survivor's perceived health 6 months after hospital discharge

Self-efficacy

Concordant expectations/shared appraisal of ARF survivor's health 6 months after hospital discharge

Study Details

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.

Conditions

Acute Respiratory Failure

Caregiving Stress

Mental Health Issue

Study ID

NCT06401239

Start date

Jul 23, 2024

Status verified date

Feb, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

235 participants

Anticipated

Interventions and Outcome Measures

Arms

ARF Survivor-Care Partner Dyads

The study will recruit 235 dyads of adult ARF survivors and care partners. The term "care partner" refers to an individual (e.g. family member or friend) that supports the survivor at home.

Interventions

Dyadic expectations about the ARF survivor's perceived health 6 months after hospital discharge

Dyad members' expectations will be collected at baseline and at 3- month follow-up assessments using a visual analogue scale (VAS) ranging from 0 - 100, similar to the EQ-5D-VAS.

Self-efficacy

Self-efficacy in both dyad members will be assessed at 3- and 6-month follow-up assessments using the Generalized Self-Efficacy Scale (GSE). The GSE has 10 items scored on a 4-point scale. U.S. adult population norms are available.

Concordant expectations/shared appraisal of ARF survivor's health 6 months after hospital discharge

Dyad members' expectations will be collected at baseline and at 3- month follow-up assessments using a visual analogue scale (VAS) ranging from 0 - 100, similar to the EQ-5D-VAS.

Primary outcome measure

  • Symptoms of Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3 and 6 months after ARF survivor's ICU discharge ]
  • Dyadic Coping as Assessed by the Dyadic Coping Inventory (DCI) [ Time Frame: 3 and 6 months after ARF survivor's ICU discharge ]

Central Contacts and Locations

Central contacts

Ann M Parker, MD, PhD

410-955-2190ann.parker@jhmi.edu

Omar R Valentin

410-502-2140ovalent1@jh.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Ann M Parker, MD, PhD

410-955-2190ann.parker@jhmi.edu

Omar R Valentin

ovalent1@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • ARF survivor
  • Caregiver
  • ICU recovery
  • Dyadic coping
  • Dyadic self-efficacy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-02-05.