Investigating Dyadic Expectations About ARF Survivorship (IDEAS)

NCT06401239 | Recruiting

• 2 other identifiers: IRB00429340R01HL163660
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Symptoms of Post Traumatic Stress as Measured by the Impact of Events Scale-Revised (IES-R)

  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)

  3 and 6 months after ARF survivor's hospital discharge

• Social Isolation as Measured by Social Isolation Score

  3 and 6 months after ARF survivor's hospital discharge

• Financial Toxicity as Assessed by Qualitative Questions

  3 and 6 months after ARF survivor's hospital discharge

Study Arms (1)

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; Other: Self-efficacy; Other: Concordant expectations/shared appraisal of ARF survivor's health 6 months after hospital discharge

Interventions

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

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.

ARF Survivor-Care Partner Dyads

Self-efficacy OTHER

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.

ARF Survivor-Care Partner Dyads

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

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.

ARF Survivor-Care Partner Dyads

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥18 years old
• Meets study definition of ARF:
• The study defines ARF as meeting 1 of the following 3:
• Mechanical ventilation via an endotracheal tube ≥24 consecutive hours OR
• Non-invasive ventilation (CPAP, BiPAP) ≥24 consecutive hours that is not for obstructive sleep apnea or other stable use OR
• 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.

You may not qualify if:

• 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
• ≥18 years old
• Speaks or reads English or Spanish
• Pre-existing cognitive impairment (IQ-CODE \>3.6)

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 36682611 BACKGROUND

• 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.

  PMID: 33052404 BACKGROUND

• 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.

  PMID: 31464769 BACKGROUND

• 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.

  PMID: 32590386 BACKGROUND

Related Links

• Study description at NIH RePORTER

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Ann M Parker, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann M Parker, MD, PhD

CONTACT

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

Omar R Valentin

CONTACT

410-502-2140; ovalent1@jh.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 6, 2024
• Study Start: July 23, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: At or prior to publication dates.
• 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.

Locations

US (1)