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

This study is currently recruiting participants.
Verified January 2013 by National Heart, Lung, and Blood Institute (NHLBI)
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00719446
First received: July 18, 2008
Last updated: May 8, 2013
Last verified: January 2013
  Purpose

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
Respiratory Distress Syndrome, Adult

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Outcomes 6 and 12 Months After ALTA, OMEGA, EDEN and SAILS ARDS Network Trials

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Health Care Utilization, Employment Status, Health Insurance Status [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: October 2007
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719446

Contacts
Contact: Dale M. Needham, MD, PhD 410-955-3467 dale.needham@jhmi.edu
Contact: Victor D. Dinglas, MPH 410-955-3467 victor.dinglas@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Dale M. Needham, MD, PhD    410-955-3467    dale.needham@jhmi.edu   
Principal Investigator: Dale M. Needham, MD, PhD         
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Carl Shanholtz, MD       cshanhol@medicine.umaryland.edu   
Principal Investigator: Carl Shanholtz, MD         
United States, North Carolina
Wake Forest University Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Peter Morris, MD    336-716-4649    pemorris@wfubmc.edu   
Principal Investigator: Peter Morris, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: James C. Jackson, PsyD    615-936-2822    james.c.jackson@Vanderbilt.Edu   
Principal Investigator: Wes Ely, MD, MPH         
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Ramona A. Hopkins, PhD    801-507-4569    Ramona.Hopkins@imail.org   
Principal Investigator: Ramona A. Hopkins, PhD         
United States, Washington
University of Washington/Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Catherine L. Hough, MD, MSc       cterrlee@u.washington.edu   
Principal Investigator: Catherine L Hough, MD, MSc         
Sponsors and Collaborators
Investigators
Principal Investigator: Dale M. Needham, MD, PhD Johns Hopkins University
Principal Investigator: Ramona O Hopkins, PhD Intermountain Medical Center
  More Information

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00719446     History of Changes
Other Study ID Numbers: 589, R01HL091760
Study First Received: July 18, 2008
Last Updated: May 8, 2013
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Acute Lung Injury

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on April 17, 2014