Investigating Dyadic Expectations About ARF Survivorship (IDEAS)

NCT ID: NCT06401239

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

235 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-23

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Respiratory Failure Caregiving Stress Mental Health Issue

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.


* ≥18 years old
* Speaks or reads English or Spanish

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


* Pre-existing cognitive impairment (IQ-CODE \>3.6)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alison E Turnbull, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alison E Turnbull, PhD

Role: CONTACT

410-955-2190

Deanna J Rahman

Role: CONTACT

9143084938

Facility Contacts

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Alison E. Turnbull, PhD

Role: primary

410-955-2190

References

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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.

Reference Type BACKGROUND
PMID: 36682611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33052404 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31464769 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32590386 (View on PubMed)

Related Links

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Other Identifiers

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R01HL163660

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00429340

Identifier Type: -

Identifier Source: org_study_id

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