Adjustable Gastric Band Survey Study (AGB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01041534|
Recruitment Status : Unknown
Verified July 2012 by David Flum, University of Washington.
Recruitment status was: Active, not recruiting
First Posted : December 31, 2009
Last Update Posted : July 6, 2012
|Condition or disease||Intervention/treatment|
|Morbid Obesity||Other: Survey|
While there has been considerable energy focused on the costs and effectiveness of bariatric surgery, there has been little systematically-gathered evidence on the non-surgical care and healthcare expenditures for similarly burdened patients. The economic burden and clinical impact of both need to be more carefully defined to help guide DOD decision making regarding obesity care. Understanding the cost effectiveness of obesity treatments is also critical given the cost of treatment procedures, their potential for saving future costs related to co-morbid health conditions and worker productivity and the growing population of operative candidates.
This study will provide a comprehensive assessment of the burden and costs of operative and non-operative obesity care across all regions in the U.S. where the Department of Defense (DOD) authorizes care. The development of economic assessment tools will allow health policy experts, purchasers and payers of healthcare, clinicians and patients to determine the utility and cost-effectiveness of available treatment strategies. These economic considerations are relevant to the competing crises of spiraling health care costs and the loss of productivity related to obesity.
The specific purpose of this study is to provide a comprehensive assessment of the burden and costs of operative and non-operative obesity care to develop a set of economic assessment tools that will allow health policy experts, purchasers and payers of healthcare, clinicians and patients to determine the utility and cost-effectiveness of available treatment strategies for managing obesity. Utility refers to qualitative components affected by clinical conditions such as individual's perceptions of quality of life, ability to take care of one-self, or ability to work/be productive. We anticipate that utility changes greatly for people who are able to achieve weight loss, but the differences or degree to which operative and non-operative weight loss treatments affects utility is not well known.
In particular, less is known about the effect of Adjustable Gastric Band (AGB) surgery on utility because it has only emerged as a predominant form of surgical treatment in the United States approximately within the last five years - for example, the first AGB surgery at UWMC was only performed in April 2007. In addition, assessment of cost-effectiveness of treatments requires understanding healthcare use after treatment (i.e. how many follow-up visits do you have with a doctor because of your surgical treatment) and AGB requires frequent follow-up visits in the first three years to make the surgical treatment effective. There is little information or research reporting the actual frequency of which patients are receiving follow-up care after AGB surgery, the cost for that care (is it a patient cost or insurance covered), or whether frequency of follow-up care affects long-term weight loss or health outcomes.
While the original procedures of our related study (IRB #35310, Committee E/A) only included secondary analysis of existing datasets, we have found very little information about qualitative utility or use/frequency of follow-up care for AGB patients and feel these are important aspects for modeling treatment choices for patients considering AGB. By adding a survey component, we will capture these data elements that are otherwise not found in literature or administrative datasets.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Data Investigation of Bariatric Surgery and Economic Savings: Adjustable Gastric Band (AGB) Survey Study|
|Study Start Date :||July 2009|
|Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||September 2012|
Adjustable Gastric Band (AGB) surgery
Patients who have undergone adjustable gastric band (AGB) surgery at the UWMC or other sites that have agreed to cooperate with our site (letter of cooperation and HIPAA waiver approved by our IRB) between April 1, 2007 and July 1, 2008.
Two surveys are sent to patients: Adjustable gastric band (AGB) Health Survey and a quality of life survey (EQ5D)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01041534
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98119|
|Principal Investigator:||David R Flum, MD, MPH||University of Washington|