APPENDIX B
INSTITUTIONAL REVIEW BOARD
Mail: P.O. Box 3999 In Person: Dahlberg Hall
Atlanta, Georgia 30302-3999 30 Courtland St, Suite 217
Phone: 404/413- 3500 Fax:
4 04/413-3504
October 06, 2014
Principal Investigator: Patricia Clark
Key Personnel: Clark, Patricia; Davis, Nicole
Study Department: GSU - B.F. Lewis School of Nursing
Study Title: Using Telehealth to Support Informal Caregivers of Elders with Urinary Incontinence - 2
Funding Agency: John A. Hartford Foundation, John A. Hartford Foundation Review Type: Expedited 7
IRB Number: H15144 Reference Number: 329829
Approval Date: 10/06/2014 Expiration Date: 10/05/2015
The Georgia State University Institutional Review Board (IRB) reviewed and approved the above referenced study in accordance with 45 CFR 46.111. The IRB has reviewed and approved the study and any informed consent forms, recruitment materials, and other research materials that are marked as approved in the application. The approval period is listed above. Research that has been approved by the IRB may be subject to further appropriate review and approval or disapproval by officials of the Institution.
Federal regulations require researchers to follow specific procedures in a timely manner. For the protection of all concerned, the IRB calls your attention to the following obligations that you have as Principal Investigator of this study.
1. For any changes to the study (except to protect the safety of participants), an Amendment Application must be submitted to the IRB. The Amendment Application must be reviewed and approved before any changes can take place
2. Any unanticipated/adverse events or problems occurring as a result of participation in this study must be reported immediately to the IRB using the Unanticipated/Adverse Event Form.
3. Principal investigators are responsible for ensuring that informed consent is properly documented in accordance with 45 CFR 46.116.
The Informed Consent Form (ICF) used must be the one reviewed and approved by the IRB with the approval dates stamped on each page.
4. For any research that is conducted beyond the approval period, a Renewal Application must be submitted at least 30 days prior to the expiration date. The Renewal Application must be approved by the IRB before the expiration date else automatic termination of this study will occur. If the study expires, all research activities associated with the study must cease and a new application must be approved before any work can continue.
5. When the study is completed, a Study Closure Report must be submitted to the IRB.
All of the above referenced forms are available online at http://protocol.gsu.edu. Please do not hesitate to contact the Office of Research Integrity (404-413-3500) if you have any questions or concerns.
Sincerely,
Ann Kruger, IRB Chair
APPENDIX C
APPENDIX D Telephone Visit Protocol
Using Telehealth to Support Informal Caregivers of Elders with UI Telephone Visit Protocol
Materials:
1. Blue or black ink pen 2. Telephone visit Log
General Approach:
1. CGs will be called by the Student PI on a weekly basis during the 6-week study period. 2. At the beginning of each call, the Student PI will introduce herself and remind the CG of the
purpose of the telephone call. (see Telephone Script)
3. The Student PI will explain the content that will be discussed and time required, at the outset of the telephone call.
4. The Student PI will be sensitive to CG time and the need to reschedule the call for a more convenient time, as indicated by the CG.
5. The Student PI will maintain a log of the duration of the call and content discussed. 6. The telephone log will also indicate the outcome of the call (e.g., call completed, no
answer/message left, no answer/no message, wrong number, asked to call back later, refused) and number of previous attempts to contact the CG.
7. At the conclusion of the telephone call, CGs will be asked to schedule the date and time of the next weekly telephone visit.
Telephone Script
Hello Mr/s. ________________________________, this is Nicole Davis from the Tele-Prompt research study. I am calling to complete your weekly telephone visit. How have you and your _(care-recipient)______been? (Pause for response). I realize you must be very busy, so this should only take about 20 minutes of your time. Is now an ok time for our visit?
Yes: Wonderful, let’s go ahead and get started. Today we will be discussing________(topics listed below)
No: Ok, no problem. When would be a better time to call you (later today or another time this week)? Thank you and I look forward to talking with you later.
Discussion Topics
1. Tele-Prompt Group Topics (order to be followed for each CG during every weekly
telephone visit)
a) Modules viewed during this week
b) Answer any question CG may have regarding information covered in the modules
c) Discuss and troubleshoot challenges in viewing modules d) Discuss progress with prompted-voiding
e) Discuss and troubleshoot challenges with prompted-voiding
f) Answer questions CG may have about the prompted-voiding technique g) Discuss technical issues with Tablet-PC
Tele-Prompt Group Script: 1) Have you viewed any modules this week?, 2) Do you have any
questions about any of the information that was given to you?; 3) Were the modules helpful to you?;4) Was there anything that prevented you from watching all or some of the modules?; 5) How are things going with the Prompted voiding?; 6) Do you have any
questions about the technique or is there anything you’d like for me to review?; 7) Have you had any problems with the Tablet-PC?
2. Control Group – Topics (Special care will be taken by the PI to not answer any CG
questions regarding UI or anything that could impact UI (e.g., fluid intake, incontinence products, if they arise)
a) Week 1 – Durable Power of Attorney b) Week 2 – Living Trusts
c) Week 3 – How to organize your important papers
d) Week 4 – Communicating Effectively with your Healthcare Provider I e) Week 5 – Communicating Effectively with your Healthcare Provider II f) Week 6 – Preparing for Emergencies or Natural Disasters
APPENDIX E 3-day Bladder Diary