Acute Respiratory FailureIDEASNCT06401239
Investigating Dyadic Expectations About ARF Survivorship (IDEAS)
An observational study of Acute Respiratory Failure and Caregiving Stress, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Caregiving Stress, Mental Health Issue
- What is being tested?
- Dyadic expectations about the ARF survivor's perceived health 6 months after hospital discharge, Self-efficacy and Concordant expectations/shared appraisal of ARF survivor's health 6 months after hospital discharge
- How many people
- 235 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Ann M Parker, MD, PhD, 410-955-2190, ann.parker@jhmi.edu
Omar R Valentin, ovalent1@jh.edu
About this study
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.
Read the 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.
- Being tested
- Dyadic expectations about the ARF survivor's perceived health 6 months after hospital discharge, Self-efficacy, Concordant expectations/shared appraisal of ARF survivor's health 6 months after hospital discharge
- Keywords
- ARF survivor, Caregiver, ICU recovery, Dyadic coping, Dyadic self-efficacy
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic expectations about the ARF survivor's perceived health 6 months after hospital dischargeOther
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-efficacyOther
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 dischargeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 and 6 months after ARF survivor's hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start23 Jul 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ann M Parker, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401239
- Sponsor's protocol ID
- IRB00429340
- Other IDs
- R01HL163660
- Acronym
- IDEAS
- Status last verified
- Feb 2026
- First submitted
- 2 May 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified datasets and supporting information underlying publications will be shared at or prior to initial publication date.
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.
PubMed 36682611Vranceanu 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.
PubMed 33052404Geense 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.
PubMed 31464769Zante 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.
PubMed 32590386
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Dyadic Expectations About ARF Survivorship (IDEAS)
- ClinicalTrials.gov ID
- NCT06401239
- Acronym / sponsor ID
- IDEAS / IRB00429340
- Keywords
- ARF survivor, Caregiver, ICU recovery, Dyadic coping, Dyadic self-efficacy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARF Survivor-Care Partner Dyads | – | 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 dischargeThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic expectations about the ARF survivor's perceived health 6 months after hospital dischargeDyad 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 | ARF Survivor-Care Partner Dyads |
| Self-efficacySelf-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 | ARF Survivor-Care Partner Dyads |
| Concordant expectations/shared appraisal of ARF survivor's health 6 months after hospital dischargeDyad 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 | ARF Survivor-Care Partner Dyads |
Primary outcome
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.
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.
4 secondary outcomes
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
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
Social Isolation as Measured by Social Isolation Score
Time frame: 3 and 6 months after ARF survivor's hospital discharge
Financial Toxicity as Assessed by Qualitative Questions
Time frame: 3 and 6 months after ARF survivor's hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 36682611Turnbull 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.
- Background: PubMed 33052404Vranceanu 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.
- Background: PubMed 31464769Geense 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.
- Background: PubMed 32590386Zante 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.
- Study description at NIH RePORTERLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified datasets and supporting information underlying publications will be shared at or prior to initial publication date.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann M Parker, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Caregiving Stress, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann M Parker, MD, PhD (410-955-2190, ann.parker@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06401239, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.