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NCT Number: NCT06401239

Investigating Dyadic Expectations About ARF Survivorship (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.

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Key information

Conditions

Acute Respiratory Failure Behavior Behavioral Symptoms Caregiver Burden Caregiving Stress Mental Health Issue Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Patient Inclusion Criteria:

  • ≥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.

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)

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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

    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.

  2. Dyadic Coping as Assessed by the Dyadic Coping Inventory (DCI)

    Time frame: 3 and 6 months after ARF survivor's ICU discharge

    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.

Secondary outcomes

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

    Time frame: 3 and 6 months after ARF survivor's hospital discharge

    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.

  2. Health-related Quality of Life as Measured by the European Quality of Life 5-Domain 5-level Questionnaire (EQ-5D-5L)

    Time frame: 3 and 6 months after ARF survivor's hospital discharge

    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. Social Isolation as Measured by Social Isolation Score

    Time frame: 3 and 6 months after ARF survivor's hospital discharge

    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.

  4. Financial Toxicity as Assessed by Qualitative Questions

    Time frame: 3 and 6 months after ARF survivor's hospital discharge

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ann M Parker, MD, PhD

CONTACT

[email protected]

410-955-2190

Omar R Valentin

CONTACT

[email protected]

410-502-2140

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: IDEAS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 6, 2024
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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