INVESTIGATOR:   Alex Mroszczyk-McDonald, M.D. & Robert E. Sallis, M.D.
9961 Sierra Ave
Fontana, CA, 92335

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You are being asked to be in a research study regarding exercise and it’s impact on Quality of life in patients with spinal cord injuries which is being supported by Kaiser Permanente (KP) and The Perfect Step (TPS). You are being asked to take part in this research because you are an adult over age 18 with a spinal cord injury and enrolled in the TPS  program. This study plans to determine how regular exercise impacts quality of life in patients with spinal cord injuries. This information will help us understand how important exercise is for patients with spinal cord injuries.

Your decision to be in this study is completely voluntary. You do not have to participate in any research project offered by Kaiser Permanente.

PURPOSE
The purpose of this study is to demonstrate the effect of regular exercise on quality of life, complication rate and number and strength of any medication, in patients who had sustained spinal cord injuries.

DURATION
If you decide to participate, we will be asking you to answer series of questions about your quality of life that will take about 10-12 minutes to complete. We will also ask some basic information about you, like how long you have been enrolled at the TPS, how many medications you take and dose, any complications you may experience as well as if you have experienced a reduction in symptoms since being enrolled in TPS.  Please feel free to have friends and family help you with information that you may not recall or need another perspective.

VOLUNTARY PARTICIPATION  
You do not have to answer any questions that you do not want to answer and this will in no way affect the care provided by TPS. The questions you answer as part of this research project are done for research purposes only. You can decide to share the results with your physician if you choose to do so.

STUDY PROCEDURE
As part of the research study we will ask you to answer a series of questions that help us determine how you rate your quality of life, before during and after enrollment at TPS. These questions will take about 10-12 minutes to answer. If you do score low on these measures, we will give you a list of resources in your community.  We will also recommend that you follow-up with your doctor.

RISKS
There are minimal risks to participants in this study.  The research team members from Southern California Kaiser Permanente will review your clinic information and medical record including medications prescribed and the pharmacy medical data regarding pickup and refill of prescriptions.  Some of the questions in this study may be considered sensitive, may be difficult to answer or may cause uncomfortable feelings. You can refuse to answer or skip any questions.  The main risk is a loss of confidentiality.

BENEFITS
There is no guarantee that you will benefit from participating in this study.

ALTERNATIVES
You do not have to participate in this study and the medical care you receive will not be affected.

CONFIDENTIALITY
To maintain your confidentiality, we will only use random code numbers to identify you in our computer database. We will keep the list that matches this number to your name separate from all research study papers in a locked office of the Kaiser Permanente Fontana Medical Office. Your name, address, phone number, and email will not be entered into a computer as part of this research study. Any research staff who records your health information will be extensively trained in how to keep this kind of information private.  Our results will never be presented so that you can be identified.

COMPENSATION

You will not be paid for participating in this study.

COSTS
There are no costs to you for participating in this research study.

CONTACT INFORMATION
If you have any questions about this research study, please call Dr. Mroszczyk-McDonald  at (909) 427-4000.
If you have any questions regarding your rights as a study subject you may contact:

Armida Ayala, PhD, Director, Human Research Subjects Protection Office at
(626) 405-3665 or Armida.Ayala@kp.org 


 NO, I DO NOT WANT TO BE IN THE STUDY (If so, do not move beyond this point)

 YES, I WANT TO BE IN THE STUDY (If so, please provide your email address below and get started)

Please note: Your identity and responses will remain nameless, as we will only be using your email address to track that you have completed the survey.