Consent Form

CONSENT BY SUBJECT FOR PARTICIPATION IN PROJECT

Title of Project : Quality Improvement Project on using a Digital Therapeutic for the treatment of Type 2 Diabetic Patients in a primary care setting.

Doctor Directing Project : Dr Dominic Davis, Homewell Practice Havant Health Centre, Civic Centre Road, Havant, Hampshire, PO9 2AQ

Section A

You are being asked to participate in a general practice quality improvement project. In order to decide whether or not you want to be a part of this project, you should understand enough about its risks and benefits to make an informed judgment. This process is known as informed consent. This consent form gives detailed information about the project, which will be discussed with you. Once you understand the project, you will be asked to sign this form if you wish to participate.

Section A

I. NATURE AND DURATION OF PROCEDURE(S):

The project involve’s a 12-month online lifestyle therapy intervention called RediCare ControlDTx for lifestyle change for those with chronic illness such as Type 2 Diabetes Mellitus, Prediabetes, High Cholesterol, High Blood Pressure, Overweight or Obese conditions. It has been developed to promote lifestyle change, including eating a low carbohydrate diet, increasing physical activity while providing education on your health condition and strategies to support sustainable lifestyle change which address the root cause of chronic conditions.

If you choose to participate, you will be asked to fill out some questionnaires relating your health conditions. A Nurse from Homewell Medical Practice will take full blood samples and other physical measurements such as Weight, Height, Waist, BMI Blood Pressure, Body Fat etc. They will give you information which describe the RediCare ControlDTx online programme, you will also be given information and assistance if required on how now to access and enrol in the programme.

While you are on the programme, you will have access to all the components of the programme as described in the information leaflet, the “RediCare ControlDTx” brochure.

c. 16 weeks after enrolment you will be asked to come back to Homewell Medical Practice where you will receive another health assessment and examination, exactly as the first visit. This will involve taking another sample of your blood and re measurement of your Weight, Height, Waist, BMI, Body Fat and Blood Pressure. You will also be asked to come back to clinic to repeat the health assessment after a 6 and 12 month period from start date.

II. POTENTIAL RISKS AND BENEFITS:

No benefits can be guaranteed, but participants may benefit by losing weight and improving their clinical indicators. There may also be increases in physical activity, improvements in diet quality and diabetic status.

There are no notable risks involved with participating other than the possible risk of hypoglycaemia (low blood sugar), which is comparable to standard diabetes treatment. In the unlikely event that you should you suffer undue negative side-effects from this lifestyle change programme, you will be removed from the project and switched to regular care by your GP.

AGREEMENT TO CONSENT

Section C

The project and the treatment procedures associated with it have been fully explained to me. All experimental procedures have been identified and no guarantee has been given about the possible results. I have had the opportunity to ask questions concerning any and all aspects of the project and any procedures involved. I am aware that participation is voluntary and that I may withdraw my consent at any time. I am aware that my decision not to participate or to withdraw will not restrict my access to health care services normally available to me. Confidentiality of records concerning my involvement in this project will be maintained in an appropriate manner. When required by law, the records of this project may be reviewed by government agencies and sponsors of the research.

I understand that my clinical data may be used for de-identified statistical analysis and reporting on the prevalence of chronic and other diseases. This statistical analysis and reporting may be used for publication purposes in medical, scientific and academic publications and presented at medical conference to further the knowledge base of treating and preventing chronic disease. Your data will always be anonymous and unidentifiable.

I have received a copy of this consent for my records. I understand that if I have any questions concerning this research, I can contact the doctor(s) listed above. After reading the entire consent form, if you have no further questions about giving consent, please sign where indicated.