Monitoring Disparities in Chronic Conditions - Phase 1

General Information

Phase 1 of the MDCC Study includes an initial survey and follow-up survey about participants’ general health and well-being.
 
Below, you will find answers to questions you may have about this phase of the study, including the purpose of the research, what we would ask study participants to do, the possible risks and benefits, and your rights as a volunteer. Please let us know if you have any other questions or if there is anything about the research that is unclear. We will answer any questions you may have to help you decide if you want to be in the study.
 

Purpose of Phase 1

This survey is part of a larger study that is being conducted by the Institute for Health Metrics and Evaluation at the University of Washington in partnership with Public Health – Seattle & King County, the county health department. We are investigating the health of King County residents in general, and specifically, heart, lung, and kidney diseases. We want to learn how common these conditions are and to identify risk factors for these conditions in the community. Our goal is to develop a population-based health monitoring system that combines multiple data sources to track chronic diseases at the local level.
 

Study Procedures

The first phase will begin with a telephone or web screening, which will include demographic questions (such as age, sex, and race) about you. This screening will take approximately 15 minutes. We will attempt to contact you for this screening a maximum of seven times over a two-week period.
 
If you are determined to be eligible for the study following the screening, you will be asked to participate in the study. If you agree to participate, you will complete an initial survey that asks questions about general health (including questions about alcohol/tobacco use), diet, physical activity and exercise habits, well-being (including emotional health), and demographic information (such as education, employment, marital status, household items, and income). If you have a chronic health condition such as diabetes or heart disease, you will be asked additional questions about the condition, prescription medications being taken, other treatments for the condition, insurance status, and information about hospital and/or physician visits. Some of these questions may be sensitive in nature. Although complete information is important to the study, you may skip any question you do not wish to answer, and you can end your participation at any time without penalty or repercussions. This initial survey can be completed by telephone, mail, Internet, or during an in-home visit by a trained interviewer. Some participants may be asked to complete this survey online. The survey should take 45 minutes or less to complete, although in some cases, it may take longer.
 
You will also be asked to complete a follow-up survey that asks questions about dietary history and medications (including prescription and over-the-counter medications and dietary supplements). The follow-up survey may be completed by mail or Internet. Participants who complete the initial survey during an in-home visit have the option to complete the follow-up survey during this visit, return a paper survey by mail, or complete the survey on the Internet. Participants who complete the initial survey online will be asked to complete the follow-up survey online as well. This follow-up survey should take 30 minutes or less to complete, although some people may take longer. 
 
If you have not completed the survey within two weeks, we will remind you via a reminder card in the mail, a reminder email, or up to three attempts to reach you by phone. We will make one more attempt to remind you via email or phone two weeks later. 
 
If you are unable to or decide not to complete the initial survey, we will ask you to participate in a shorter version of the survey, which includes demographic questions (such as age, sex, and race). This will take approximately 15 minutes to complete. You may decline to participate in this short survey at any time.
 
We will also ask for your Social Security number because data from this project will be linked with publicly available data supplied by the National Center for Health Statistics (NCHS). Social Security numbers will be kept confidential according to the Privacy Act of 1974 and will be used only for research purposes. Providing a Social Security number is voluntary, and you can choose not to provide this information. If you are asked to participate in a later phases of the study, we will ask for your consent at that time to use the Social Security number to identify your medical record.  
 
Participating in Phase 1 of the study does not obligate you to participate in Phase 2 of the study. If you are asked to participate in this later phase, we will first ask for your consent to participate. You may choose not to participate in this later phase at any time.
 

Risks, Stress, or Discomfort

The risks involved in participating in this study might include invasion of privacy and breach of confidentiality. We have addressed concerns about privacy in the "Other Information" section below. Study participants are free to decline to answer any questions.
 

Benefits of the Study

There is no direct benefit to study participants from participating in the first phase of the study.  However, the results of this study will help researchers and public health officials better understand and improve the health of residents of King County.
 

Alternatives to Being in this Study

Being in this study is voluntary. You do not have to be in this study if you don't want to be. Whether you choose to participate in this study will not affect health care available to you through the University of Washington or other King County health care providers.
 

Other Information

All of the information you provide will be confidential. Personal identifiers such as names and Social Security numbers will be stored separately from survey answers and other participant data and linked through a unique study ID. Researchers working with the data will not have access to your personal identifiers. A Data Manager will manage the links between identifiers and the data. We will keep the link between participant names and study identification numbers in a secured location until Dec. 31, 2014, after which we will destroy any information that could link participant names to the coded information. Anonymous study data will be kept indefinitely. If we publish the results of this study, we will not use any names or identifying information. 
 
Study participants will not receive monetary compensation for participating in this study.
 
If you have any questions regarding rights as a research participant, please call a representative of the Human Subjects Committee at the University of Washington at +1-206-543-0098. For other questions about this study, you may contact the study researchers through the MDCC Study center at +1-800-225-8890 or via email at MDCCstudy@battelle.org.
Institute for Health Metrics and Evaluation
2301 Fifth Ave., Suite 600, Seattle, WA 98121, USA
Tel: +1.206.897.2800 Fax: +1.206.897.2899
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