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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00822965 |
Purpose
The specific aims of the patient intervention are to:
The educational interventions proposed, if proven to be effective by this pilot, will provide a low-cost, reproducible intervention to improve the clinical care and safe management of pacemakers (PM) and implantable cardioverter-defibrillators (ICD) in patients. The goal of the intervention will be to promote the safe use of implantable pulse generators.
| Condition | Intervention |
|---|---|
|
Pacemaker Implantable Cardioverter-Defibrillators |
Other: Questionnaires Other: Phone Interviews Behavioral: Educational Packet |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | Patient Knowledge of Pacemaker/Implantable Cardioverter-Defibrillator-Phase II |
| Estimated Enrollment: | 104 |
| Study Start Date: | January 2009 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patient Knowledge Assessments
Questionnaires + Phone Interview
|
Other: Questionnaires
3 sets of questionnaires at the beginning of the study, at 2-months and at 4-months.
Other Name: Survey
Other: Phone Interviews
2 follow-up phone interviews.
Behavioral: Educational Packet
Video or DVD of device information, updates, recalls, on-line resources and benefits of routine follow-up for device(s).
|
If you agree to take part in this study, you will complete 3 sets of questionnaires (at the beginning of the study, at 2-months and at 4-months) which will be sent to you and returned by you through the mail. This will not require you to travel to M.D. Anderson. In addition to the questionnaires, you will also complete 2 follow-up phone interviews.
Questionnaires:
The first set of questionnaires will be mailed to your home. The questionnaires will ask questions about your anxiety level and how much you know about pacemakers or implantable cardioverter-defibrillators. There will also be questions about your gender, age, ethnicity, and race. The questionnaires will take about 25 minutes to complete. When you are finished, you will mail the questionnaires to the study staff. An envelope with pre-paid postage will be provided.
Educational Packet:
After you have completed the questionnaires, you will receive an educational packet in the mail. The packet will have a DVD or a video (depending on whether you tell us you have a DVD player or a VHS player) with information on medical devices, device recall information (when and why certain devices have been recalled in the past), a list of on-line resources and benefits of routine follow-up.
Phone Interview:
The study staff will call your home 1 week after you receive the educational packet for a follow-up interview. A member of the study staff will review the packet with you. The phone call will last about 20 minutes.
Additional Questionnaires:
Approximately 2 months and at 4 months after you complete the first set of questionnaires, an additional set of questionnaires will be mailed to you. You will be asked to complete the same questionnaires as you did in the first set. At 4 months an additional questionnaire about the information in the educational packet and how useful it was to you will be included. The questionnaires will take about 25 minutes to complete. When you are finished, you will mail the questionnaires to the study staff. An envelope with pre-paid postage will be provided.
Length of Study:
You participation on this study is complete once you have completed the additional questionnaires.
This is an investigational study. Up to 104 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Consecutive patients presented to UTMDACC Preoperative Consultation Clinic from January 1, 2000 to November 15, 2008 with an implanted pulse generator.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Maria Suarez-Almazor, MD, PhD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00822965 History of Changes |
| Other Study ID Numbers: | 2008-0163 |
| Study First Received: | January 13, 2009 |
| Last Updated: | December 30, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Pacemakers PM Implantable cardioverter-defibrillators |
ICD Implantable pulse generators Educational Interventions |
