Effectiveness of an iphone application on Diabetes Self-Management

Transcription

1 Effectiveness of an iphone application on Diabetes Self-Management Ms Morwenna Kirwan, Dr. Corneel Vandelanotte, Dr. Mitch Duncan, Dr Andrew Fenning, Prof. Kerry Mummery Institute for Health and Social Science Research, CQUniversity, Australia PARTICIPANT INFORMATION SHEET Dear Participant, Thank you for your interest in participating in this research. Some information on the project and why it is being conducted is provided below. Background and Purpose of Study Managing Type 1 Diabetes is a life-long challenge, a constant balancing act to keep blood glucose levels within normal range, while juggling every-day life and the stressors that come with that, incorporating a healthy eating and being active. Research has demonstrated that good diabetes management prolongs your life, reduces your risk of developing the complications of nerve damage, kidney damage, retinopathy, heart disease, foot ulcers and other circulatory dysfunctions. Self-management is the key strategy to improve diabetes care and the better the glycemic control you can maintain the better the quality of your life. Since good diabetes management has been shown to decrease mortality and prevent long-term complications, there is a great need for healthcare systems to develop innovative ways to improve diabetes management, and provide timely care to patients. New information technology, such as the computer, internet, multimedia, and other forms of electronic communication, have great promise to influence diabetes care positively. Information technology provides an easy method to quickly and easily share and communicate information between patient and doctor. Over 90% of the Australian population reports owning or using a mobile phone and presents an ideal opportunity to engage Type 1 Diabetes patients with their doctor and diabetes educator. Yet the use of mobile phones for this purpose is not widespread. People with diabetes provide about 95% of their own 1 P a g e

2 care. The existing infrastructure and growing use of mobile phones makes them a potential avenue to support self-care behaviours diabetes patients. The newest generation of smart mobile phones; such as the Apple iphone support text-messaging, internet-browsing and special health-related apps. These features in addition to the portability and popularity of these devices make them a promising tool to help improve health behaviours. The main aim of the proposed study is to evaluate the effectiveness of an iphone application to improve self-management and glycemic control in patients with Type 1 Diabetes. Participation Procedure This research is focussing on adults (18 to 65 years) with Type 1 Diabetes. To participate in this research it is required that you: Own an iphone and currently not use an iphone application to self-monitor diabetes Have been diagnosed with Type 1 Diabetes for longer than 6 months Be willing to have REGULAR (3 monthly) follow-up visits with your General Practitioner and under the requirements of the Care Plan have your HbA1c test every 3 months Complete an online survey concerning your diabetes self-care every 3 months over 9 months. This will take approximately 30 mins on each occasion. If you agree to participate you will be randomly allocated to the iphone+education group, or to the Education group. If you are allocated to the iphone+education group you will be given access to a specially designed diabetes-related iphone application, and sent an Education booklet in the mail. If you are allocated to the Education group, you will be sent the Education booklet in the mail and given access to the specially designed diabetes-related iphone application after the study is completed. Participants in both groups will be required to visit their General Practitioner (GP) and ask to be involved in the EPC Medicare Care Plan Program for Diabetes. This Care Plan is a Medicare initiative which provides a Medicare rebate for allied health visits and follows the cycle of care over a 12-month period. This means you will need to visit your GP for a diabetes review and have a HbA1c blood test every three months. 2 P a g e

3 Below is an outline of what is required of you over the course of the study: Baseline: Sign up for Care Plan (or have an existing Care Plan ), Online Survey, HbA1c test 3 Month: Online Survey, HbA1c test 6 Month: Online Survey, HbA1c test 9 Month: Online Survey, HbA1c test Any information collected will not be stored or presented in a way that will allow for your identity to be known and the research team will link data only by a unique code. Your involvement in the study is completely voluntary. Should you decide to withdraw from the study for any reason, at any time, you may do so without penalty or prejudice. The results of this research are intended to be disseminated by presentation at both academic and non academic conferences and also published in academic papers. All data that is collected will be kept in a secure location for a minimum of five years and will only be made accessible to the research team. If you experience any difficulties during the completion of this study you may stop at any time, or if you have an enquiries or concerns about this research please contact Morwenna by telephone ( ), (m.kirwan@cqu.edu.au) or by post care of Building 81, CQUniversity, Rockhampton, Queensland, Please contact CQUniversity s Research Services Office at , should there be any concerns about the nature and/or conduct of this research project. Thank you for your valued contribution to this research project. Kind Regards, Ms Morwenna Kirwan (Principal Researcher) To register your interest, visit this website. 3 P a g e

4 PARTICIPANT Consent Form Effectiveness of an iphone Application on Diabetes Self-Management ****************************************************************************************************************** Name: Date of Birth: / / iphone phone Number: Alternative Phone Number: Date of Type 1 Diagnosis: Most recent HbA1c (if known) % Address: Mailing Address: State: Post Code: ****************************************************************************************************************** I (print your name), understand that by signing this form I agree to take part in this research project and that: I have read and understood the contents of the Participant Information Sheet I consent to my 3-monthly HbA1c blood test results to be shared with the research team via my General Practitioner or Practice Nurse I have spoken to a member of the research team and have been given the opportunity to ask questions about the research and these have been answered to my satisfaction All the information I provide is completely confidential. Any information relating to this project will be stored in locked filing cabinets and in password protected documents I can stop participating in the research at any time, for any reason without consequence. I am aware that any information given before I stop participating will still be used in the project The results of the project will be made available to me in a plain English statement of the findings if I request one I may be required to download & use an iphone self-management application SIGNATURE: I would like to receive a plain English statement of the findings: Yes No The confidentiality of the results of this research is assured. Your identity will be protected at all times and any research publications or presentations will be drawn from aggregated material rather than from any one individual, community or organisation. A follow-up report of the outcomes of this research will be made available to all participants. 4 P a g e

5 GENERAL PRACTITIONER Consent Form Effectiveness of an iphone application on Diabetes Self-Management I (print your name), understand that by signing this form I support my patient s (print patient s name) request to take part in this research. I understand that participants involved in this research are to see their GP and to have repeat HbA1c blood tests at 3-monthly intervals, in line with their annual cycle of diabetes care. I support the initiation of an EPC Medicare Care Plan Program for Diabetes and I consent to my patient s HbA1c results to be shared with the research team, via the Practice Nurse. I am satisfied that my patient has read and understood the contents of the Participant Information Sheet I am satisfied that my patient is aware they can stop participating in this research at any time, for any reason without consequence. I am aware that any information given before I stop participating will still be used in the project PRACTICE NURSE DETAILS (to be contacted 3-monthly for the HbA1c results) Name: Phone: Start Date of Care Plan: / / GENERAL PRACTITIONER SIGNATURE: I would like to receive a plain English statement of the findings: Yes No The confidentiality of the results of this research is assured. Your identity and the patient s will be protected at all times and any research publications or presentations will be drawn from aggregated material rather than from any one individual, community or organisation. A follow-up report of the outcomes of this research will be made available to all participants. ON COMPLETION PLEASE FAX BOTH PAGES (PAGES 4 & 5) TO: Morwenna Kirwan (07) OR SEND via POST TO: Morwenna Kirwan, Building 81, CQUniversity, Rockhampton QLD 4700 OR SCAN & TO: m.kirwan@cqu.edu.au 5 P a g e