You can also use this link to submit questions to the Research Team
Adrenal Insufficiency Study RECRUITMENT (MyAI) |
We are recruiting adult and pediatric subjects for a large study of adrenal insufficiency (AI) – with a focus on symptoms, diagnosis, quality of life, and outcomes of treatment.
WHAT:
This research project will study AI, with the goals of understanding the disease(s) better, improve treatments and look for ways to predict or prevent it.
The project is designed to enroll subjects on-line, with baseline information collected. We will also continue to monitor subjects with a focus on how they may change. We will track events that occur such as adrenal crises. This type of study is called a longitudinal observational cohort study or research registry.
As you may know, AI is a somewhat rare disease that is associated with the risk of developing adrenal crises in individuals who are stressed and cannot respond with increased cortisol. Studies from Europe show that even well-educated and presumably careful people are vulnerable to adrenal crises and at increased risk of dying. A difficult disease to manage for many people, it is not uncommon for patients to struggle with persistent symptoms of AI. Patients must take corticosteroids every day, yet taking too much or too little of this drug can result in problematic side effects.
The United States has lagged behind many of the European countries in studying AI. Therefore, we lack good data on how common the disease is here. We do not have information on how well patients are doing under the current treatment recommendations. Studies from Europe have identified increases in mortality and other issues within their populations of AI patients. This raises the question of what is happening here. The United States is much more diverse than the European countries which have conducted studies. The U.S. also has a very different health care system. This registry will collect information about who has the disease, how they are being treated and how well they are faring.
Although the primary focus of this study is the United States, the registry is open to anyone who meets the inclusion criteria – even outside the U.S. A second priority would be North America; Canadians and Central Americans could then be an additional focus.
WHO:
A previous registry through the National Adrenal Diseases Foundation enrolled approximately 1400 people, however they were almost all white individuals. We want everyone possible who has adrenal insufficiency to enroll. We would very much like to get participation from Hispanics, African Americans, Asians and other diverse populations. There is a real risk that people who have historically had difficulty being “heard” by the medical profession are not getting diagnosed with this disease. Unfortunately, when people are not diagnosed, they are more likely to die.
We also want to include people who are “at-risk” of developing AI such as individuals with a family history of AI, those who have other autoimmune diseases (thyroid disease, rheumatoid arthritis, type 1 diabetes, celiac disease etc.) and possibly people with symptoms suggestive of AI who have had negative test results. People who have been taking oral glucocorticoids (steroids, like prednisone) for other diseases also have the possibility of secondary adrenal insufficiency and we want to include them.
We also would like to have control or “normal” people for comparison. These people could-- and should--be coming from the same geographic region as the AI and at risk people. This is a great opportunity to recruit your friends or family!
Please pass on the word about this study. We would like to sign up thousands of people. There are probably 50,000-100,000 people in the U.S. with some form of adrenal insufficiency. If you are a member of a minority population, please tell people in your community about the study and encourage them to join.
WHY:
There is a great deal of work to be done to make life better for people with AI. We need better drug treatments and blood tests that can reflect how well treatments are working. With better drugs and understanding of how to treat the disease, more people will hopefully be able to return to good health and improve their quality of life. We also need to understand the mechanisms of the disease, as well as the genetic and environmental risks factors. Once we have a greater understanding of these issues, the goal needs to be prevention or reversal of the disease.
SPECIFICS:
AI patients who are participating in other research studies are welcome to be part of this registry. Please make sure to let us know when completing the data collection about the other studies or registries you are in.
Enrollment will take about 30 minutes initially, and you will need to have a working email address. If you are an AI patient, we will eventually ask you for some medical records to verify your diagnosis. These are requested from you later by email.
There is detailed information about the study included in the research consent form. You are welcome to sign up to be in the first round only. If you do only this, we will at least be able to count you. Preferably, you can continue to be part of the study for the long haul and we will contact you by email every six months for an update on your health. You also have the option to be contacted about future research studies as we try to look at genetic factors or identify better blood tests.
Please direct questions about the study to [email protected]
The study is centered at National Jewish Health in Denver and has been reviewed by the National Jewish Institutional Review Board to ensure compliance with human subjects’ research regulations. Data is being managed in compliance with HIPAA regulations.
The principal investigator is Elizabeth Regan MD, PhD
Co-Investigator:
Michael McDermott MD, University of Colorado Denver
WHAT:
This research project will study AI, with the goals of understanding the disease(s) better, improve treatments and look for ways to predict or prevent it.
The project is designed to enroll subjects on-line, with baseline information collected. We will also continue to monitor subjects with a focus on how they may change. We will track events that occur such as adrenal crises. This type of study is called a longitudinal observational cohort study or research registry.
As you may know, AI is a somewhat rare disease that is associated with the risk of developing adrenal crises in individuals who are stressed and cannot respond with increased cortisol. Studies from Europe show that even well-educated and presumably careful people are vulnerable to adrenal crises and at increased risk of dying. A difficult disease to manage for many people, it is not uncommon for patients to struggle with persistent symptoms of AI. Patients must take corticosteroids every day, yet taking too much or too little of this drug can result in problematic side effects.
The United States has lagged behind many of the European countries in studying AI. Therefore, we lack good data on how common the disease is here. We do not have information on how well patients are doing under the current treatment recommendations. Studies from Europe have identified increases in mortality and other issues within their populations of AI patients. This raises the question of what is happening here. The United States is much more diverse than the European countries which have conducted studies. The U.S. also has a very different health care system. This registry will collect information about who has the disease, how they are being treated and how well they are faring.
Although the primary focus of this study is the United States, the registry is open to anyone who meets the inclusion criteria – even outside the U.S. A second priority would be North America; Canadians and Central Americans could then be an additional focus.
WHO:
A previous registry through the National Adrenal Diseases Foundation enrolled approximately 1400 people, however they were almost all white individuals. We want everyone possible who has adrenal insufficiency to enroll. We would very much like to get participation from Hispanics, African Americans, Asians and other diverse populations. There is a real risk that people who have historically had difficulty being “heard” by the medical profession are not getting diagnosed with this disease. Unfortunately, when people are not diagnosed, they are more likely to die.
We also want to include people who are “at-risk” of developing AI such as individuals with a family history of AI, those who have other autoimmune diseases (thyroid disease, rheumatoid arthritis, type 1 diabetes, celiac disease etc.) and possibly people with symptoms suggestive of AI who have had negative test results. People who have been taking oral glucocorticoids (steroids, like prednisone) for other diseases also have the possibility of secondary adrenal insufficiency and we want to include them.
We also would like to have control or “normal” people for comparison. These people could-- and should--be coming from the same geographic region as the AI and at risk people. This is a great opportunity to recruit your friends or family!
Please pass on the word about this study. We would like to sign up thousands of people. There are probably 50,000-100,000 people in the U.S. with some form of adrenal insufficiency. If you are a member of a minority population, please tell people in your community about the study and encourage them to join.
WHY:
There is a great deal of work to be done to make life better for people with AI. We need better drug treatments and blood tests that can reflect how well treatments are working. With better drugs and understanding of how to treat the disease, more people will hopefully be able to return to good health and improve their quality of life. We also need to understand the mechanisms of the disease, as well as the genetic and environmental risks factors. Once we have a greater understanding of these issues, the goal needs to be prevention or reversal of the disease.
SPECIFICS:
AI patients who are participating in other research studies are welcome to be part of this registry. Please make sure to let us know when completing the data collection about the other studies or registries you are in.
Enrollment will take about 30 minutes initially, and you will need to have a working email address. If you are an AI patient, we will eventually ask you for some medical records to verify your diagnosis. These are requested from you later by email.
There is detailed information about the study included in the research consent form. You are welcome to sign up to be in the first round only. If you do only this, we will at least be able to count you. Preferably, you can continue to be part of the study for the long haul and we will contact you by email every six months for an update on your health. You also have the option to be contacted about future research studies as we try to look at genetic factors or identify better blood tests.
Please direct questions about the study to [email protected]
The study is centered at National Jewish Health in Denver and has been reviewed by the National Jewish Institutional Review Board to ensure compliance with human subjects’ research regulations. Data is being managed in compliance with HIPAA regulations.
The principal investigator is Elizabeth Regan MD, PhD
Co-Investigator:
Michael McDermott MD, University of Colorado Denver
