Investigating Dyadic Expectations About ARF Survivorship (IDEAS) (IDEAS)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Failure; Mental Health Issue; Caregiving Stress
• Intervention / Treatment: Other: Dyadic expectations about the ARF survivor's perceived health 6 months after hospital discharge; Other: Self-efficacy; Other: Concordant expectations/shared appraisal of ARF survivor's health 6 months after hospital discharge

Detailed Description

The overarching objectives of the Investigating Dyadic Expectations about ARF Survivorship (IDEAS) cohort study are to learn how expectations about ARF survivorship are related to dyadic mental health symptoms and dyadic coping. Specifically, the study aims are:

• Aim 1: To determine whether health expectations and self-efficacy after acute respiratory failure (ARF) are associated with mental health outcomes in survivor-care partner dyads.
• Aim 2: To assess whether concordant expectations within survivor-care partner dyads are associated with better dyadic coping (primary outcome) and exploratory secondary outcomes.

The term dyadic coping refers to the ways two people interact as the pair manage illness-related stressors. Concordant expectations within dyads, also called shared appraisal, refers to both members of a dyad being "on the same page", and is hypothesized to lead to better dyadic coping behaviors.

• Study Type: Observational
• Enrollment (Estimated): 235

Contacts and Locations

• Study Contact: Name: Ann M Parker, MD, PhD; Phone Number: 410-955-2190; Email: ann.parker@jhmi.edu
• Study Contact Backup: Name: Omar R Valentin; Phone Number: 410-502-2140; Email: ovalent1@jh.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: Ann M Parker, MD, PhD; Phone Number: 410-955-2190; Email: ann.parker@jhmi.edu
      • Contact: Omar R Valentin; Email: ovalent1@jh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study team will enroll adults who were treated for ARF in ICUs at Johns Hopkins Hospital and Bayview Medical Center in Baltimore, Maryland.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: 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.; Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)	Symptoms of anxiety and depression in both members of enrolled dyads will be assessed at 3- and 6-month follow-up assessments using the HADS. The HADS has 14 items. Scores for the anxiety and depression subscales range from 0 - 21 with scores ≥8 reflective of clinically significant symptoms.	3 and 6 months after ARF survivor's ICU discharge
Dyadic Coping as Assessed by the Dyadic Coping Inventory (DCI)	Dyadic coping will be assessed at 3- and 6-month assessments using the Dyadic Coping Inventory (DCI).The DCI contains 37 items that will be answered by both dyad members. Items are rated on a 5-point scale ranging from 1 ("Very rarely") to 5 ("Very often") and the total DCI score is the sum of items 1 through 35 after reverse coding negatively keyed items. There are established cut-off scores to evaluate dyadic coping as follows: DCI total score < 111 reflects below average dyadic coping, DCI between 111-145 reflects normal dyadic coping, and DCI total score > 145 reflects above average dyadic coping.	3 and 6 months after ARF survivor's ICU discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of Post Traumatic Stress as Measured by the Impact of Events Scale-Revised (IES-R)	Symptoms of Post Traumatic Stress in both members of enrolled dyads will be measured by the IES-R. The IES-R has 22-items, a total raw score range of 0-88, and subscales for Intrusion, Avoidance, and Hyperarousal. Higher scores indicate more symptoms of post-traumatic stress.	3 and 6 months after ARF survivor's hospital discharge
Social Isolation as Measured by Social Isolation Score	Social isolation experienced by both members of the enrolled dyad will be measured by a social isolation score developed by Pohl and colleagues for the National Health and Aging Trends Study (NHATS). The score is derived from responses to 5 questions and ranges from 0 to 6 with high scores indicating greater isolation.	3 and 6 months after ARF survivor's hospital discharge
Health-related Quality of Life as Measured by the European Quality of Life 5-Domain 5-level Questionnaire (EQ-5D-5L)	The Health-related Quality of Life of the ARF survivor will be measured by the EQ-5D-5L. The EQ-5D-5L is made up of 6 items addressing mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and self-rated health. Index values will be calculated for the first 5 dimentions and converted to a US-based index value with negative values indicating states worse than death and 1.0 indicating perfect health. Self-rated health is assessed on a 0 - 100 scale with higher values indicating better perceived health. Population norms are available.	3 and 6 months after ARF survivor's hospital discharge
Financial Toxicity as Assessed by Qualitative Questions	Financial Toxicity will be assessed by asking both members of the dyad whether the dyad have experienced 12 indicators of financial hardship since the index hospitalization. This list of indicators has previously been used in two peer-reviewed prospective cohort studies of people who survived hospitalization for COVID-19.	3 and 6 months after ARF survivor's hospital discharge

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Ann M Parker, MD, PhD, Johns Hopkins University

Publications and helpful links

General Publications

• Turnbull AE, Lee EM, Dinglas VD, Beesley S, Bose S, Banner-Goodspeed V, Hopkins RO, Jackson JC, Mir-Kasimov M, Sevin CM, Brown SM, Needham DM; Addressing Post-Intensive Care Syndrome-01 (APICS-01) Study Team. Health Expectations and Quality of Life After Acute Respiratory Failure: A Multicenter Prospective Cohort Study. Chest. 2023 Jul;164(1):114-123. doi: 10.1016/j.chest.2023.01.016. Epub 2023 Jan 19.
• Vranceanu AM, Bannon S, Mace R, Lester E, Meyers E, Gates M, Popok P, Lin A, Salgueiro D, Tehan T, Macklin E, Rosand J. Feasibility and Efficacy of a Resiliency Intervention for the Prevention of Chronic Emotional Distress Among Survivor-Caregiver Dyads Admitted to the Neuroscience Intensive Care Unit: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020807. doi: 10.1001/jamanetworkopen.2020.20807.
• Geense WW, van den Boogaard M, van der Hoeven JG, Vermeulen H, Hannink G, Zegers M. Nonpharmacologic Interventions to Prevent or Mitigate Adverse Long-Term Outcomes Among ICU Survivors: A Systematic Review and Meta-Analysis. Crit Care Med. 2019 Nov;47(11):1607-1618. doi: 10.1097/CCM.0000000000003974.
• Zante B, Camenisch SA, Schefold JC. Interventions in Post-Intensive Care Syndrome-Family: A Systematic Literature Review. Crit Care Med. 2020 Sep;48(9):e835-e840. doi: 10.1097/CCM.0000000000004450.

Helpful Links

• Study description at NIH RePORTER

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Caregiver; ICU recovery; ARF survivor; Dyadic coping; Dyadic self-efficacy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Behavior; Caregiver Burden
• Other Study ID Numbers: IRB00429340; R01HL163660 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified datasets and supporting information underlying publications will be shared at or prior to initial publication date.
• IPD Sharing Time Frame: At or prior to publication dates.
• IPD Sharing Access Criteria: Datasets and associated metadata and documentation maintained by JHRDR is findable and identifiable through a digital object identifier (DOI) created by Johns Hopkins Data Services (JHRDR). Study data reposited in JHRDR will be available to the research community in perpetuity.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No