Acute Respiratory FailureOSEARNCT03797313
Observational Study of Expected ARF Recovery
An observational study of Acute Respiratory Failure and Post Intensive Care Syndrome, run by Johns Hopkins University at 4 sites in United States.
Trial summary
This is an observational cohort study of the association between patient expectations for functional recovery and quality of life among acute respiratory failure survivors 6 months after hospital discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Post Intensive Care Syndrome
- How many people
- 180 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Jan 2019to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: survivors of acute respiratory failure (ARF) who are expected to be discharged home alive.
Who may be able to join
- Age ≥ 18 years
- Respiratory failure managed in the ICU, where respiratory failure is defined as ≥1 of the following:
- Mechanical ventilation via an endotracheal tube ≥ 24 hours OR
- Non-invasive ventilation (CPAP, BiPAP) ≥ 24 consecutive hours* provided for acute respiratory failure (not for Obstructive Sleep Apnea or other stable use) OR
- High flow nasal cannula with FIO2 ≥ 0.5 and flow rate ≥ 30 LPM for ≥ 24 consecutive hours*
- Occasional rest periods of ≤ 1 hour each are not deducted from the calculation of consecutive hours.
- Expected by the clinical team to be discharged home alive
Who cannot join
- Patient in ICU < 24 hours
- Mechanical ventilation at baseline or mechanical ventilation solely for airway protection or obstruction
- Residing in a medical institution at the time of hospital admission
- Homeless / Prisoner / Primary residence not in the USA / Unable to communicate by telephone in English
- More than mild dementia (either known diagnosis of moderate or worse dementia or IQ-CODE > 3.6; screening performed on patients > 50 years old or with family reports of possible memory decline)
- Patient on hospice at or before time of enrollment
Show all 9Show fewer
- Patients who, based solely on pre-existing medical problems (such as poorly controlled neoplasm or other end stage disease, including Stage IV heart failure or severe burns), would not be expected to survive 6 months in the absence of the acute respiratory failure.
- Patients with neurological injury either receiving treatment for intracranial hypertension or who are not expected to return to consciousness.
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Intermountain Medical Center
Murray, Utah, 84107
Vanderbilt University
Nashville, Tennessee, 37235
About this study
Official title: Observational Study of Expected Acute Respiratory Failure (ARF) Recovery
This is an observational cohort study of the association between patient expectations for functional recovery and quality of life among acute respiratory failure survivors 6 months after hospital discharge.
Read the detailed description
This study will enroll adults who are diagnosed with acute respiratory failure during an ICU admission and discharged from the ICU alive. All participants will receive usual clinical care. Participant expectations for functional recovery will be assessed before hospital discharge via a standardized questionnaire containing a visual analogue scale and questions about expected ability and importance of being able to perform activities of daily living and instrumental activities of daily living in 6 months. At 6 months, participants will be re-contacted by phone. Study staff will administer questionnaires to assess whether patient expectations have been met. Quality of life will be assessed using the WHOQOL-BREF and the EQ-5D-VAS.
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient's expectations met at Hospital discharge | ARF survivors whose expectations for recovery at hospital discharge are fully met 6 months later. | |
| Patient's with unmet expectations at Hospital Discharge | ARF survivors whose expectations for recovery at hospital discharge are not fully met 6 months later. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measured using the World Health Organization Quality of Life-BREF instrument (WHOQOL-BREF) after hospital discharge
WHOQOL-BREF is a measure of overall quality of life that evaluates satisfaction with important aspects of life rather than of health. The instrument contains 26 items across 4 domains, and requires approximately 5 minutes to administer over the phone. The 26 items in the WHOQOL-BREF are scored in four domains: physical, psychological, social relations, and environment, with between 3 and 8 items in each domain and two "benchmark" items addressing overall QoL. Transforming the raw scores results in a domain score between 0 - 100, enabling comparisons between domains with different numbers of items. Higher scores indicate greater participant satisfaction with their quality of life and lower scores indicate worse satisfaction with quality of life.
Measured: 6 months after hospital discharge
Secondary outcomes (1)
Patient expectation error measure using EQ-5D VAS
A secondary analysis will estimate patient expectation error, defined as the difference between the health-related quality of life score expected at hospital discharge and the actual health related quality of life score assessed using the EQ-5D VAS 6 months after hospital discharge. The EQ-5D VAS ranges from 0 to 100 with 0 representing the worst imaginable health state and 100 representing the best imaginable health state.
Measured: 6 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start22 Jan 2019
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)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
- 180 participants (actual)
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
- Alison Turnbull, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797313
- Sponsor's protocol ID
- IRB00197235
- Other IDs
- 00181895, K01HL141637-01
- Acronym
- OSEAR
- Status last verified
- Feb 2021
- First submitted
- 7 Jan 2019
- Last updated
- 15 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rubenfeld GD, Caldwell E, Peabody E, Weaver J, Martin DP, Neff M, Stern EJ, Hudson LD. Incidence and outcomes of acute lung injury. N Engl J Med. 2005 Oct 20;353(16):1685-93. doi: 10.1056/NEJMoa050333.
PubMed 16236739Cox CE, Docherty SL, Brandon DH, Whaley C, Attix DK, Clay AS, Dore DV, Hough CL, White DB, Tulsky JA. Surviving critical illness: acute respiratory distress syndrome as experienced by patients and their caregivers. Crit Care Med. 2009 Oct;37(10):2702-8. doi: 10.1097/CCM.0b013e3181b6f64a.
PubMed 19865004Spragg RG, Bernard GR, Checkley W, Curtis JR, Gajic O, Guyatt G, Hall J, Israel E, Jain M, Needham DM, Randolph AG, Rubenfeld GD, Schoenfeld D, Thompson BT, Ware LB, Young D, Harabin AL. Beyond mortality: future clinical research in acute lung injury. Am J Respir Crit Care Med. 2010 May 15;181(10):1121-7. doi: 10.1164/rccm.201001-0024WS. Epub 2010 Mar 11.
PubMed 20224063Zambon M, Vincent JL. Mortality rates for patients with acute lung injury/ARDS have decreased over time. Chest. 2008 May;133(5):1120-7. doi: 10.1378/chest.07-2134. Epub 2008 Feb 8.
PubMed 18263687Phua J, Badia JR, Adhikari NK, Friedrich JO, Fowler RA, Singh JM, Scales DC, Stather DR, Li A, Jones A, Gattas DJ, Hallett D, Tomlinson G, Stewart TE, Ferguson ND. Has mortality from acute respiratory distress syndrome decreased over time?: A systematic review. Am J Respir Crit Care Med. 2009 Feb 1;179(3):220-7. doi: 10.1164/rccm.200805-722OC. Epub 2008 Nov 14.
PubMed 19011152Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
PubMed 21946660Hopkins RO, Suchyta MR, Kamdar BB, Darowski E, Jackson JC, Needham DM. Instrumental Activities of Daily Living after Critical Illness: A Systematic Review. Ann Am Thorac Soc. 2017 Aug;14(8):1332-1343. doi: 10.1513/AnnalsATS.201701-059SR.
PubMed 28463657Kamdar BB, Huang M, Dinglas VD, Colantuoni E, von Wachter TM, Hopkins RO, Needham DM; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome Network. Joblessness and Lost Earnings after Acute Respiratory Distress Syndrome in a 1-Year National Multicenter Study. Am J Respir Crit Care Med. 2017 Oct 15;196(8):1012-1020. doi: 10.1164/rccm.201611-2327OC.
PubMed 28448162Lieu TA, Au D, Krishnan JA, Moss M, Selker H, Harabin A, Taggart V, Connors A; Comparative Effectiveness Research in Lung Diseases Workshop Panel. Comparative effectiveness research in lung diseases and sleep disorders: recommendations from the National Heart, Lung, and Blood Institute workshop. Am J Respir Crit Care Med. 2011 Oct 1;184(7):848-56. doi: 10.1164/rccm.201104-0634WS.
PubMed 21965016Carson SS, Goss CH, Patel SR, Anzueto A, Au DH, Elborn S, Gerald JK, Gerald LB, Kahn JM, Malhotra A, Mularski RA, Riekert KA, Rubenfeld GD, Weaver TE, Krishnan JA; American Thoracic Society Comparative Effectiveness Research Working Group. An official American Thoracic Society research statement: comparative effectiveness research in pulmonary, critical care, and sleep medicine. Am J Respir Crit Care Med. 2013 Nov 15;188(10):1253-61. doi: 10.1164/rccm.201310-1790ST.
PubMed 24160906Cox CE, Martinu T, Sathy SJ, Clay AS, Chia J, Gray AL, Olsen MK, Govert JA, Carson SS, Tulsky JA. Expectations and outcomes of prolonged mechanical ventilation. Crit Care Med. 2009 Nov;37(11):2888-94; quiz 2904. doi: 10.1097/CCM.0b013e3181ab86ed.
PubMed 19770733Lamas DJ, Owens RL, Nace RN, Massaro AF, Pertsch NJ, Gass J, Bernacki RE, Block SD. Opening the Door: The Experience of Chronic Critical Illness in a Long-Term Acute Care Hospital. Crit Care Med. 2017 Apr;45(4):e357-e362. doi: 10.1097/CCM.0000000000002094.
PubMed 27632675Turnbull AE, Davis WE, Needham DM, White DB, Eakin MN. Intensivist-reported Facilitators and Barriers to Discussing Post-Discharge Outcomes with Intensive Care Unit Surrogates. A Qualitative Study. Ann Am Thorac Soc. 2016 Sep;13(9):1546-52. doi: 10.1513/AnnalsATS.201603-212OC.
PubMed 27294981Thompson AG, Sunol R. Expectations as determinants of patient satisfaction: concepts, theory and evidence. Int J Qual Health Care. 1995 Jun;7(2):127-41. doi: 10.1093/intqhc/7.2.127.
PubMed 7655809Gonzalez Saenz de Tejada M, Escobar A, Herrera C, Garcia L, Aizpuru F, Sarasqueta C. Patient expectations and health-related quality of life outcomes following total joint replacement. Value Health. 2010 Jun-Jul;13(4):447-54. doi: 10.1111/j.1524-4733.2009.00685.x. Epub 2010 Jan 15.
PubMed 20088892
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Expected Acute Respiratory Failure (ARF) Recovery
- ClinicalTrials.gov ID
- NCT03797313
- Acronym / sponsor ID
- OSEAR / IRB00197235
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 9 Jan 2019 (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.
This is an observational cohort study of the association between patient expectations for functional recovery and quality of life among acute respiratory failure survivors 6 months after hospital discharge.
Detailed description
This study will enroll adults who are diagnosed with acute respiratory failure during an ICU admission and discharged from the ICU alive. All participants will receive usual clinical care. Participant expectations for functional recovery will be assessed before hospital discharge via a standardized questionnaire containing a visual analogue scale and questions about expected ability and importance of being able to perform activities of daily living and instrumental activities of daily living in 6 months. At 6 months, participants will be re-contacted by phone. Study staff will administer questionnaires to assess whether patient expectations have been met. Quality of life will be assessed using the WHOQOL-BREF and the EQ-5D-VAS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient's expectations met at Hospital discharge | – | –ARF survivors whose expectations for recovery at hospital discharge are fully met 6 months later. |
| Patient's with unmet expectations at Hospital Discharge | – | –ARF survivors whose expectations for recovery at hospital discharge are not fully met 6 months later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- survivors of acute respiratory failure (ARF) who are expected to be discharged home alive.
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Respiratory failure managed in the ICU, where respiratory failure is defined as ≥1 of the following:
- Mechanical ventilation via an endotracheal tube ≥ 24 hours OR
- Non-invasive ventilation (CPAP, BiPAP) ≥ 24 consecutive hours* provided for acute respiratory failure (not for Obstructive Sleep Apnea or other stable use) OR
- High flow nasal cannula with FIO2 ≥ 0.5 and flow rate ≥ 30 LPM for ≥ 24 consecutive hours*
Key exclusion criteria (9 listed)
- Patient in ICU < 24 hours
- Mechanical ventilation at baseline or mechanical ventilation solely for airway protection or obstruction
- Residing in a medical institution at the time of hospital admission
- Homeless / Prisoner / Primary residence not in the USA / Unable to communicate by telephone in English
- More than mild dementia (either known diagnosis of moderate or worse dementia or IQ-CODE > 3.6; screening performed on patients > 50 years old or with family reports of possible memory decline)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life measured using the World Health Organization Quality of Life-BREF instrument (WHOQOL-BREF) after hospital discharge
Time frame: 6 months after hospital discharge
WHOQOL-BREF is a measure of overall quality of life that evaluates satisfaction with important aspects of life rather than of health. The instrument contains 26 items across 4 domains, and requires approximately 5 minutes to administer over the phone. The 26 items in the WHOQOL-BREF are scored in four domains: physical, psychological, social relations, and environment, with between 3 and 8 items in each domain and two "benchmark" items addressing overall QoL. Transforming the raw scores results in a domain score between 0 - 100, enabling comparisons between domains with different numbers of items. Higher scores indicate greater participant satisfaction with their quality of life and lower scores indicate worse satisfaction with quality of life.
1 secondary outcome
Patient expectation error measure using EQ-5D VAS
Time frame: 6 months after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Background: PubMed 16236739Rubenfeld GD, Caldwell E, Peabody E, Weaver J, Martin DP, Neff M, Stern EJ, Hudson LD. Incidence and outcomes of acute lung injury. N Engl J Med. 2005 Oct 20;353(16):1685-93. doi: 10.1056/NEJMoa050333.
- Background: PubMed 19865004Cox CE, Docherty SL, Brandon DH, Whaley C, Attix DK, Clay AS, Dore DV, Hough CL, White DB, Tulsky JA. Surviving critical illness: acute respiratory distress syndrome as experienced by patients and their caregivers. Crit Care Med. 2009 Oct;37(10):2702-8. doi: 10.1097/CCM.0b013e3181b6f64a.
- Background: PubMed 20224063Spragg RG, Bernard GR, Checkley W, Curtis JR, Gajic O, Guyatt G, Hall J, Israel E, Jain M, Needham DM, Randolph AG, Rubenfeld GD, Schoenfeld D, Thompson BT, Ware LB, Young D, Harabin AL. Beyond mortality: future clinical research in acute lung injury. Am J Respir Crit Care Med. 2010 May 15;181(10):1121-7. doi: 10.1164/rccm.201001-0024WS. Epub 2010 Mar 11.
- Background: PubMed 18263687Zambon M, Vincent JL. Mortality rates for patients with acute lung injury/ARDS have decreased over time. Chest. 2008 May;133(5):1120-7. doi: 10.1378/chest.07-2134. Epub 2008 Feb 8.
- Background: PubMed 19011152Phua J, Badia JR, Adhikari NK, Friedrich JO, Fowler RA, Singh JM, Scales DC, Stather DR, Li A, Jones A, Gattas DJ, Hallett D, Tomlinson G, Stewart TE, Ferguson ND. Has mortality from acute respiratory distress syndrome decreased over time?: A systematic review. Am J Respir Crit Care Med. 2009 Feb 1;179(3):220-7. doi: 10.1164/rccm.200805-722OC. Epub 2008 Nov 14.
- Background: PubMed 21946660Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
- Background: PubMed 28463657Hopkins RO, Suchyta MR, Kamdar BB, Darowski E, Jackson JC, Needham DM. Instrumental Activities of Daily Living after Critical Illness: A Systematic Review. Ann Am Thorac Soc. 2017 Aug;14(8):1332-1343. doi: 10.1513/AnnalsATS.201701-059SR.
- Background: PubMed 28448162Kamdar BB, Huang M, Dinglas VD, Colantuoni E, von Wachter TM, Hopkins RO, Needham DM; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome Network. Joblessness and Lost Earnings after Acute Respiratory Distress Syndrome in a 1-Year National Multicenter Study. Am J Respir Crit Care Med. 2017 Oct 15;196(8):1012-1020. doi: 10.1164/rccm.201611-2327OC.
- Background: PubMed 21965016Lieu TA, Au D, Krishnan JA, Moss M, Selker H, Harabin A, Taggart V, Connors A; Comparative Effectiveness Research in Lung Diseases Workshop Panel. Comparative effectiveness research in lung diseases and sleep disorders: recommendations from the National Heart, Lung, and Blood Institute workshop. Am J Respir Crit Care Med. 2011 Oct 1;184(7):848-56. doi: 10.1164/rccm.201104-0634WS.
- Background: PubMed 24160906Carson SS, Goss CH, Patel SR, Anzueto A, Au DH, Elborn S, Gerald JK, Gerald LB, Kahn JM, Malhotra A, Mularski RA, Riekert KA, Rubenfeld GD, Weaver TE, Krishnan JA; American Thoracic Society Comparative Effectiveness Research Working Group. An official American Thoracic Society research statement: comparative effectiveness research in pulmonary, critical care, and sleep medicine. Am J Respir Crit Care Med. 2013 Nov 15;188(10):1253-61. doi: 10.1164/rccm.201310-1790ST.
- Background: PubMed 19770733Cox CE, Martinu T, Sathy SJ, Clay AS, Chia J, Gray AL, Olsen MK, Govert JA, Carson SS, Tulsky JA. Expectations and outcomes of prolonged mechanical ventilation. Crit Care Med. 2009 Nov;37(11):2888-94; quiz 2904. doi: 10.1097/CCM.0b013e3181ab86ed.
- Background: PubMed 27632675Lamas DJ, Owens RL, Nace RN, Massaro AF, Pertsch NJ, Gass J, Bernacki RE, Block SD. Opening the Door: The Experience of Chronic Critical Illness in a Long-Term Acute Care Hospital. Crit Care Med. 2017 Apr;45(4):e357-e362. doi: 10.1097/CCM.0000000000002094.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Respiratory Failure
Not yet recruitingObservational study
Diaphragm Response in Elderly for Acute Monitoring
Acute Dyspnea, Acute Respiratory Failure
Not yet recruiting
Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure
Acute Respiratory Failure (ARF), Nitric Oxide
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
RecruitingPhase 2
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome, Infections
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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. This study is not recruiting at the moment.
Alison Turnbull principal investigator
Johns Hopkins University
4 sites 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 Post Intensive Care Syndrome, run by Johns Hopkins University at 4 sites 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?
The sponsor lists 7 inclusion and 9 exclusion criteria. 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: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life measured using the World Health Organization Quality of Life-BREF instrument (WHOQOL-BREF) after hospital discharge (time frame: 6 months after hospital discharge). 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 NCT03797313, which also lists 30 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 15 Dec 2021.