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Consent Form

Maine Medical Center
Authorization to Participate in a Research Project


STUDY TITLE: Web-based Program for Symptom Management in Fibromyalgia

CONSENT VERSION DATE: February 18, 2009

INSTITUTIONAL REVIEW BOARD (IRB) PROVIDING OVERSIGHT FOR PROTECTION OF HUMAN SUBJECTS: Maine Medical Center

INSTITUTION CONDUCTING THE STUDY: Collinge and Associates

STUDY SPONSOR: National Institute for Arthritis, Musculoskeletal and Skin Diseases, National Institutes of Health

INVESTIGATOR: William Collinge, Ph.D., M.P.H.


You are being asked to volunteer for a research study. Research studies include only patients who choose to take part. In order to decide whether you should agree to be part of this research study, you should understand enough about its risks and benefits to make an informed judgment. This process is known as informed consent. Please take your time to make your decision.

You are being asked to take part in this study because you have fibromyalgia (FM).

WHY IS THIS STUDY BEING DONE?
The symptoms of FM can be made better or worse by various daily life events, lifestyle habits and behaviors. We want to find out if a simple computer program that keeps track of these influences can help people find the ways that work best for them to reduce their symptoms and improve their well-being.

HOW MANY PEOPLE WILL TAKE PART IN THE CLINICAL TRIAL?
2200.

WHAT IS INVOLVED IN THE STUDY?
If you take part in this study, you will have the following tasks and activities:

  • Complete an Application Form which contains demographic information (your age, marital status, race/ethnicity, health conditions you have or have had, etc.) and an email address for communication regarding your participation in the project. NOTE: An email address will be used only for communication about this project. It will not be shared by Collinge and Associates with any other entity. To preserve your privacy we recommend you create an email address that does not contain any parts of your real name. You can create an anonymous email address for free at Yahoo.com, Hotmail.com, or other websites that give free email services.   
       
  • Complete a questionnaire online once each month while you are participating in the study. This should take less than 30 minutes each time. The questionnaire will consist of the following:
       
       1: Fibromyalgia Impact Questionnaire – ten questions asking you to rate the impact of FM on your daily life.
       
       2: SF-12 – twelve questions rating the quality of your life in terms of pain, functioning and well-being.
       
       3: Health-Related Self-Efficacy Scale – six questions rating how confident you are that you can influence your health.
       
       4: Health Locus of Control Scale – 18 questions rating how much you feel you can control aspects of your health.
       
       5: Health Services Utilization – a simple count of your number of visits to health care service providers within the past month.
       
  • Use the project website program called “SMART Log” (SMART=Self-Monitoring and Review Tool). The SMART Log is a brief questionnaire to help you keep track of behaviors, life events and health management strategies over a 24 hour period that might influence your symptoms. Your SMART Log will include factors found in research and clinical practice to influence symptoms of FM. You will also be able to “personalize” your SMART Log by adding things unique to your life that you believe might be relevant to your health (e.g., medicines, supplements you might want to try, family stresses, etc.).
       
  • You will have your own user name and password to access the website to complete your SMART Log regularly, see your SMART Profiles, and use the other features of the site.
       
  • For at least three months, and a maximum of nine months (depending on the stage of the project), we will ask you to visit the web site several times each week to fill in your SMART Log for what occurred over the past 24 hours. This should take about five to ten minutes each time, and also will include a brief rating of your symptom levels.
       
  • The website will also provide you an optional “journal” feature. This will be a place where you can record personal notes, comments, observations and reflections on your health and on the SMART Log experience whenever you wish. Using the journal is not required. However, it may be a helpful way for you to gain new insights into your health over time. Dr. Collinge will have access to the journal comments of all participants to use in evaluating the program and in planning future research studies. However, any use or publication of journal comments would not include any way of identifying you.
       
  • After your first month of using SMART Log, you will be able to see your SMART Profile. Your SMART Profile will be produced by a statistical analysis program on the web site. This program will analyze all the information you have entered into your SMART Log over time, including your symptom levels. It will attempt to find relationships between the items in your SMART Log and your symptom levels over time. Your SMART Profile may confirm things you already suspect, and it may also show you things you may not have been aware of. For example, someone’s SMART Profile might tell them that if they have an average bed time of 9:45 for a week, their pain levels significantly decrease. Someone else may discover that having two or more cups of coffee in the morning makes their symptoms worse, but one cup is okay. The purpose of your SMART Profile will be to give you personalized, useful feedback about what behaviors and lifestyle factors in your life may help you reduce your symptoms and improve your well being.
       
  • Procedures that are considered experimental and are being tested in this trial: the SMART Log and SMART Profile are experimental procedures to determine their usefulness for people with FM in managing their symptoms and improving well-being.
     

HOW LONG WILL I BE IN THE STUDY?
You are encouraged to participate for at least three months and will be able to for a maximum of nine months depending on the stage of the project. You are free to cease participation at any time.

However, if you decide to stop participating in the study, we encourage you to email the researcher about your reasons and your thoughts about the project.

WHAT ARE THE RISKS OF THE STUDY?
Psychological discomfort is possible as a result of completing questionnaires which ask you to think about your emotional well-being, quality of life, symptoms and health beliefs. Psychological distress is also possible if you judge yourself to be inadequate or ineffective in your use of the SMART Log program, or if you feel discouraged about feedback you may get or not get from your SMART Profile. We will attempt to prevent these possibilities by providing realistic and accurate instructions about the usefulness and limitations of the program.

ARE THERE BENEFITS TO TAKING PART IN THE CLINICAL TRIAL?
You may gain new insights into how your behavior, lifestyle and daily life events affect your symptom levels and well being. This may allow you to make new choices that improve your health over time.

You will also be contributing to knowledge that may help other FM sufferers in the future.

WHAT OTHER OPTIONS ARE THERE?
The alternative is to not participate.

WHAT ABOUT CONFIDENTIALITY?
We will not collect any personally identifying information about you. There is no place in the program for you to enter your name or contact information, other than an email address which can be an anonymous email address that does not use your real name. We ask all participants to create an email address at one of the free web-based email sites such as Yahoo.com or Hotmail.com for use for project-related communication.

For access to the website and to use the program you will create a username and password. Again, however, we will have no way of linking these to your true identity.

Questionnaires and forms: There will be no paper materials collected or used during the study. All data will be collected online via the project website.

Web site data: You will enter your SMART Log and optional journal information into the project web site from your home computer. You will have a username and password to access the site and enter this data. This data will be collected in a database on the project’s secure server. Access to the database will be restricted through the use of public-key cryptography to access only by machines authorized by Dr. Collinge and the host system will be secured according to industry best-practices.

WHAT ARE THE COSTS?
There are no costs to you for participating.

You are responsible for all health-related outcomes that occur to you during participation in this project.

WHAT ARE MY RIGHTS AS A PARTICIPANT?
Taking part in this study is your choice. You may choose not to take part or may leave the study at any time. Leaving the study will not result in any penalty or loss of benefits to which you are entitled.

We will tell you about new information that may affect your willingness to stay in this study.
  


PERMISSION TO USE IDENTIFIABLE HEALTH INFORMATION FOR RESEARCH PURPOSES



DEFINITION OF “IDENTIFIABLE”:
For participation we will not collect information about your personal identity. The only potentially identifiable information would be the username and password you choose and the email address you provide to receive communication about the project. An email address is technically considered a form of potentially identifiable information. Therefore we ask that you create an anonymous email address at one of the free email hosts such as Yahoo or Hotmail, to help preserve your anonymity. However, there is no guarantee that an email address will remain anonymous.

WHY AM I BEING ASKED TO PROVIDE THIS INFORMATION?
As part of this clinical trial, you are being asked to provide Dr. Collinge with health information about yourself. This information will be collected, entered onto a database with the health information from others taking part in this clinical trial, and studied in order to determine the usability and possible benefits of the SMART Log program for managing symptoms of FM.

WHAT AM I BEING ASKED TO PROVIDE?
You are asked to provide the following information:
   
   1: Basic information about your age, race/ethnicity, religion, education, employment and marital status.
   
   2: Basic information about your diagnosis.
   
   3: Questionnaire responses about your symptoms, the quality of your life, and attitudes and beliefs about your health.
   
   4: Brief information about daily symptom levels and life events and behaviors related to your health.

WHO WILL SEE THIS INFORMATION?
This information will be seen by the Investigator (Dr. William Collinge), a computer programmer (Robert Soltysik), and a statistician (Dr. Paul Yarnold) who will analyze the data.

Personnel or members of the Maine Medical Center Institutional Review Board, the National Institute for Arthritis, Musculoskeletal and Skin diseases, or the federal Office of Human Research Protections may also see parts of the information you provide for this study to assure that subjects’ rights and safety are protected and, therefore, may see your username, password and the email address you choose to use for communication with the project. The information collected is the property of Collinge and Associates, and you will not be able to get it back.

WILL THE INFORMATION COLLECTED AS PART OF THIS STUDY BE DESTROYED WHEN IT IS NO LONGER NEEDED?
In the event of any publication regarding this study, the email address you use for the study will not be disclosed. It is difficult for Dr. Collinge to know how long your information will be kept -- at least until the end of the clinical trial, but most likely it will be kept on a database at Dr. Collinge’s office for an indefinite length of time. We do not know when your information will no longer be used, and there is no expiration date after which it will be discarded.

CAN I STOP MY INFORMATION FROM BEING USED?
You can cease participation at any time you wish. If you leave the study, and do not wish to have any of your personal data used, you may notify the investigator by email, and all information you have previously provided will be deleted from the study’s database.

WHAT IF I DO NOT WISH TO PROVIDE MY HEALTH INFORMATION?
Then you will not be able to participate in the study.

WHO DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study contact Dr. William Collinge at (207)439-8049 or collinge@fmwellness.org.

For questions about your rights as a research participant, contact the Maine Medical Center Institutional Review Board (which is a group of people who review the research to protect your rights) at (207) 885-8195. Dr. Kenneth Ault is the chairperson of the Maine Medical Center Institutional Review Board.
 


CONFIRMATION OF CONSENT


I have read the above information and agree to participate in this study. I also authorize the investigator to use my personal health information for the purpose of this research. I have been offered ample opportunity to ask questions and have received answers that fully satisfy those questions.

Click here to print out a copy of this form. You may also review this form any time you wish by going to the Project Info Page on the website.

By clicking on the box below, I confirm that I am over age 18 and that I agree to participate in this study.


 

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