Evaluating Health Outcomes and QOL After ALI Among Participants of the ALTA, OMEGA, EDEN, and SAILS ARDS Network Trials (ALTOS)

• ClinicalTrials.gov Identifier: NCT00719446
• Recruitment Status: Completed
• First Posted: July 21, 2008
• Last Update Posted: September 1, 2015
• Sponsor: Johns Hopkins University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Dale Needham, Johns Hopkins University

Study Description

Brief Summary:

Acute lung injury (ALI) is a severe lung condition that causes respiratory failure. The ARDS Network (ARDSNet) is a National Heart, Lung, and Blood Institute-sponsored network that is focused on improving treatments for people with ALI and a similar condition called acute respiratory distress syndrome (ARDS). This study will evaluate participants who were enrolled in one of three ARDSNet studies to examine how the treatments carried out in the prior studies affect participants' long-term health outcomes and quality of life.

Condition or disease
Respiratory Distress Syndrome, Adult

Detailed Description:

ALI, a life-threatening condition that involves inflammation of the lungs and fluid accumulation in the air sacs, typically leads to low blood oxygen levels and respiratory failure. Common causes of ALI include pneumonia, sepsis, and lung trauma. Symptoms, including breathing difficulty, low blood pressure, and organ failure, usually develop within 24 to 48 hours of the original injury or illness. Most patients require immediate care in an intensive care unit (ICU), and the main form of treatment is mechanical ventilation, which delivers oxygen and a continuous level of pressure to the damaged lungs. The ARDS Network (ARDSNet) is a group of hospitals and medical centers that conduct research to improve treatment options for people with ARDS and ALI. This study will enroll people who participated in the ARDSNet's ALTA, OMEGA, EDEN, or SAILS study; these studies are investigating new treatments to improve survival and reduce the amount of time people remain on mechanical ventilation in the ICU after ALI. It is not known whether the ARDSNet's treatments have any prolonged benefit for patients after they leave the hospital. The purpose of this study is to evaluate participants' quality of life and long-term health outcomes after they receive the ALTA, OMEGA, EDEN, or SAILS study treatments.

This study will enroll participants who were in the ALTA, OMEGA, EDEN, or SAILS study. ARDS Network trial participants from sites that approved this follow-up study will be contacted by phone at 6 and 12 months to complete a collection of surveys. These surveys assess quality of life, mental health, memory and cognition, physical functioning, fatigue, employment and health insurance status, and health care utilization. At the end of each follow-up, participants will be asked for feedback regarding their experience during the follow-up.

For participants from a sub-set of ARDS Network study sites participating in this study, researchers will review participants' medical records and information collected during the ARDSNet studies. Six and 12 months after ALI, participants will attend study visits at which time walking ability, lung function, and muscle strength will be measured. Weight, dietary changes, and changes in muscle and fat composition will also be assessed. Participants will take part in interviews to evaluate memory and cognition. If participants cannot attend the study visits, research staff will either visit participants' homes to complete the evaluations or conduct some of the evaluations over the phone.

Study Design

• Study Type: Observational
• Actual Enrollment: 922 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Patient Outcomes 6 and 12 Months After ALTA, OMEGA, EDEN and SAILS ARDS Network Trials
• Study Start Date: October 2007
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: October 2014

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Individual Physical Function and Mental Health domains from SF-36 (for participants who complete the phone surveys); 6-minute walk distance and memory evaluation (for participants who attend the study visits) [ Time Frame: Measured at Months 6 and 12 ]

Secondary Outcome Measures :

1. Quality of life, mental health, memory and cognition, physical functioning, fatigue, walking ability, lung function, muscle strength, weight, dietary changes, and changes in muscle and fat composition [ Time Frame: Measured at Months 6 and 12 ]
   Short Form-36 domains, EQ-5D, Hospital Anxiety and Depression Scale, Impact of Event Scale-Revised, Mini-Mental State Examination, FACIT-Fatigue, Functional Performance Inventory, Wechsler Memory Scale - Logical Memory 1/2, Wechsler Adult Intelligence Scale - Digit Span and Similarities, Controlled Oral Word Association Test, Hayling Sentence Completion, Cognistat - Orientation and Judgment, Timed 4 Meter Walk, Hand grip, Manual Muscle Test, Maximal Inspiratory Pressure, Anthropometrics, DEXA

Other Outcome Measures:

1. Health Care Utilization, Employment Status, Health Insurance Status [ Time Frame: Measured at Months 6 and 12 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Participants who were enrolled in the ALTA, EDEN, OMEGA, or SAILS study.

Criteria

Inclusion Criteria:

• Participated in the ALTA, EDEN, OMEGA, or SAILS study
• Survived until hospital discharge

Exclusion Criteria:

• Does not understand or speak English
• Has no fixed address
• Pre-existing cognitive impairment that prevents completion of the study assessments

Contacts and Locations

Locations

United States, Maryland

University of Maryland Medical Center

Baltimore, Maryland, United States, 21201

Johns Hopkins University

Baltimore, Maryland, United States, 21205

United States, North Carolina

Wake Forest University

Winston Salem, North Carolina, United States, 27157

United States, Tennessee

Vanderbilt University

Nashville, Tennessee, United States, 37232

United States, Utah

Intermountain Medical Center

Murray, Utah, United States, 84107

United States, Washington

University of Washington/Harborview Medical Center

Seattle, Washington, United States, 98104

Sponsors and Collaborators

Johns Hopkins University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Dale M. Needham, MD, PhD; Johns Hopkins University
• Principal Investigator: Ramona O Hopkins, PhD; Intermountain Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Brown SM, Wilson E, Presson AP, Zhang C, Dinglas VD, Greene T, Hopkins RO, Needham DM; with the National Institutes of Health NHLBI ARDS Network. Predictors of 6-month health utility outcomes in survivors of acute respiratory distress syndrome. Thorax. 2017 Apr;72(4):311-317. doi: 10.1136/thoraxjnl-2016-208560. Epub 2016 Jul 20.

Dinglas VD, Hopkins RO, Wozniak AW, Hough CL, Morris PE, Jackson JC, Mendez-Tellez PA, Bienvenu OJ, Ely EW, Colantuoni E, Needham DM. One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome: prospective follow-up of SAILS randomised trial. Thorax. 2016 May;71(5):401-10. doi: 10.1136/thoraxjnl-2015-208017. Epub 2016 Mar 2.

Needham DM, Colantuoni E, Dinglas VD, Hough CL, Wozniak AW, Jackson JC, Morris PE, Mendez-Tellez PA, Ely EW, Hopkins RO. Rosuvastatin versus placebo for delirium in intensive care and subsequent cognitive impairment in patients with sepsis-associated acute respiratory distress syndrome: an ancillary study to a randomised controlled trial. Lancet Respir Med. 2016 Mar;4(3):203-12. doi: 10.1016/S2213-2600(16)00005-9. Epub 2016 Jan 29.

Dinglas VD, Huang M, Sepulveda KA, Pinedo M, Hopkins RO, Colantuoni E, Needham DM; NIH NHLBI ARDS Network. Personalized contact strategies and predictors of time to survey completion: analysis of two sequential randomized trials. BMC Med Res Methodol. 2015 Jan 9;15:5. doi: 10.1186/1471-2288-15-5.

Needham DM, Dinglas VD, Bienvenu OJ, Colantuoni E, Wozniak AW, Rice TW, Hopkins RO; NIH NHLBI ARDS Network. One year outcomes in patients with acute lung injury randomised to initial trophic or full enteral feeding: prospective follow-up of EDEN randomised trial. BMJ. 2013 Mar 19;346:f1532. doi: 10.1136/bmj.f1532.

• Responsible Party: Dale Needham, Associate Professor, Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00719446
• Other Study ID Numbers: 589; R01HL091760 ( U.S. NIH Grant/Contract )
• First Posted: July 21, 2008
• Last Update Posted: September 1, 2015
• Last Verified: August 2015

Keywords provided by Dale Needham, Johns Hopkins University:

Acute Lung Injury

Additional relevant MeSH terms:

Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury