Evaluation of Effectiveness of Diabetes Education Programs

PRINCIPAL EVALUATORS: Dr. Martha Archuleta, Extension Food and Nutrition Specialist, New Mexico State University and Dr. Richard Jackson, Medical Director, Joslin Diabetes Center, Harvard Medical School.

DESCRIPTION: We are interested in how your participation in educational programs on diabetes management helps people with Type 2 diabetes manage their disease. We are also interested in how these programs affect your medical test results and your exercise level. During today’s class, you will be given some medical tests and surveys. After that you will attend one more educational session where you will be given the same medical tests and surveys.

The medical tests include:

  • Blood pressure
  • Blood glucose
  • A1-C
  • Cholesterol

The two surveys include one on physical activity before the classes begin and the second at the follow up class approximately one month after the first class. Completing the surveys and the medical tests will take approximately 30 minutes.

VOLUNTARY PARTICIPATION: Your participation in receiving the medical tests and filling out the surveys is entirely voluntary. You may quit at any time. If you do not wish to receive the tests or fill out the surveys, you can still participate in the educational programs.

CONFIDENTIALITY: Your test results and survey answers will be kept private. You will never be identified by name in reports. Only information about the whole group will be discussed.

BENEFITS: Participating in the educational programs will assist you in managing your diabetes. The results of the study will be used to determine effective ways to educate people with diabetes about diabetes management and exercise.

EXCLUSION CRITERIA: If any of the following conditions apply to you, you are not allowed to participate in this study. Regular use of a cane or walker; inability to walk due to musculoskeletal problems; chest pain the previous week; a heart attack, angioplasty, or heart surgery in the previous 3 months; resting heart rate less than 50 beats per minute; resting heart rate greater than 100 beats per minute; or your doctor has told you not to exercise. Do any of these conditions apply to you? Yes No (please initial)

I have my physician’s approval for exercise? YesNo (please initial)

RISKS: All necessary safety precautions will be taken when the tests are done. There is a slight risk of bruising, bleeding and infection from taking the finger stick blood sample. There may also be some pressure and/or discomfort from the blood pressure cuff. There are no risks from filling out the surveys. This exercise program consists of moderate exercise similar to everyday walking and is designed to enhance diabetes management. You can quit at any time during the course of this study.

CONTACT PEOPLE: If you have any questions, please contact Dr. Martha Archuleta at (505) 646-3516. If you have any questions about your rights, please contact the Office of the Vice Provost for Research at (505) 646-2481.

RESULTS: You can obtain the results of this study by submitting a written request to Dr. Martha Archuleta, Box 30003 MSC 3AE, Las Cruces, NM88003.

SIGNATURE: Your signature indicates that you understand what is being asked of you, and that you agree to participate.

Signature ______Date ______

Witness signature (if participant is unable to provide signature) ______