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

August 31, 2015 updated by: Dale Needham, Johns Hopkins University

Patient Outcomes 6 and 12 Months After ALTA, OMEGA, EDEN and SAILS ARDS Network Trials

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

922

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157
        • Wake Forest University
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington/Harborview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measured at Months 6 and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured at Months 6 and 12

Other Outcome Measures

Outcome Measure
Time Frame
Health Care Utilization, Employment Status, Health Insurance Status
Time Frame: Measured at Months 6 and 12
Measured at Months 6 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 18, 2008

First Submitted That Met QC Criteria

July 18, 2008

First Posted (Estimate)

July 21, 2008

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 589
  • R01HL091760 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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