Investigating Dyadic Expectations About ARF Survivorship (IDEAS)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

≥18 years old

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

235 Participants
are divided into 1 treatment group
Group A: ARF Survivor-Care Partner Dyads3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
3 and 6 months after ARF survivor's ICU discharge
2

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.

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

Secondary outcomes

1

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.

Time frame
3 and 6 months after ARF survivor's hospital discharge
2

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.

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

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.

Time frame
3 and 6 months after ARF survivor's hospital discharge
4

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.

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

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator