UWI Mobile DSMS Project Guidelines
Thinking about being a Research Participant?
Here is some information that might help you decide if you want to be a participant in this study:
Why is this research being done?
A research study is a scientific investigation in which people can help researchers find ways to solve problems in the real world. These studies are a vital part of the process by which new treatments are approved for use. Before applications, devices or new approaches can be used by the general public, they should be tested in smaller groups of people to make sure they meet the needs of the target group and are effective. This study examines the use of mobile phones for the delivery of diabetes self-management support (DSMS). The objective of the research is to demonstrate how the mobile phone can improve the accessibility and availability of DSMS through a ‘mobile support group’ thereby improving the self-management practices of the participants.
How long is the study?
This study will last 12 weeks.
What will happen to me?
First, the study will be thoroughly explained to you and you will have an opportunity to ask all of your questions. When you have a good understanding of the study and are interested in taking part, you will be asked to sign a consent form. By signing the consent form, you are not releasing any of your rights as a research participant. The participant will be asked to fill out some questionnaires to obtain information on their current self-management practices as well as mobile phone usage. They will then use the mobile application developed by the researchers at the University for the duration of the study. At the end of the study the participants will be asked to provide some feedback on their usage of the application and complete some final tests.
Can anything bad happen to me?
This research study has been preapproved by the University of the West Indies Ethics Committee before participants can be enrolled. The committee is an independent group made up of both medical experts and other persons from the organization. It is the committee’s job to make sure the study is as safe as possible and worth the risks involved.
What is in it for me?
Participating in this research study gives you a chance to play an active part in your own healthcare and help others, too. It might help you directly by giving you access to an investigational and new procedure you would not otherwise be able to receive at that time. Or, you may agree to participate just so you can contribute to scientific research, even though you may not receive any direct benefit from the research.
Will I get paid?
Participation in this study is strictly on a voluntary basis. There will be no monetary remuneration but at the end of the trial you will have a chance to win a blood pressure monitoring device.
Will it cost anything to be in the study?
In this study the costs associated with the use of the mobile application and pre and post study instruments are considered part of the study will be covered by the study.
What if I end the study early?
You may withdraw from the study at any time and for any reason. If you decide to withdraw, inform the study coordinator of your decision. You may need to undergo an exit interview.
What other treatments could I take?
This study does not in any way prevent you from your regular treatment routine. If however, you are on a treatment or are going to start a treatment that my hinder your participation in this study, you should inform the study coordinator.
What are my rights?
The patient has full access to all data collected on him/her during the study period. If any of the data collected is going to be used for any purpose other than that of this study, the patient’s authorization must be obtained.
What are my responsibilities if I join?
- To use the mobile application on a regular basis
- To ensure all equipment supplied (if any) are kept in working condition
- To ensure all equipment supplied (if any) are kept in a safe and secure environment
- To report any abnormal events that may arise through the use of the system to the study coordinator
- To undergo periodic feedback interviews and questionnaires
What about confidentiality?
All data collected on each patient will be kept private. The necessary security measures will be taken to secure data that are stored electronically.
What if I get hurt in the study?
The mobile application is not designed to cause the patient harm. If the patient experiences any harm through the use of the system, he/she should contact the study coordinator immediately. Please note that when using the system, the patient should also use his/her previous health care knowledge. Therefore if something does not seem ‘normal’, the patient should contact the study coordinator for assistance.
What is in it for the University of the West Indies and the study doctors?
This project aims at providing an alternative platform for the delivery of diabetes self-management support (DSMS) using mobile phones. This study is one of many initiatives at the University that addresses the challenges associated with the management and costs related to chronic non-communicable diseases such as diabetes. The learning and feedback from this pilot study will be fed into the future systems of this kind and contribute to the fields of Mobile Health and DSMS.
For more information or if you have any questions about your rights as a research participant contact:
Mrs. Salys Lackan
Study Coordinator, Mobile DSMS Project
Phone: 868-308-0506
Email: salys.lackan@sta.uwi.edu
