Enhancing Knowledge Implantable Cardioverter-Defibrillators (ICDs)
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2009 |
| End Date: | January 2015 |
Patient Knowledge of Pacemaker/Implantable Cardioverter-Defibrillator-Phase II
The specific aims of the patient intervention are to:
1. increase patient knowledge about pacemakers (PM) and implantable
cardioverter-defibrillators (ICDs)
2. help patients to identify if their PM or ICD has been interrogated
3. improve patient's physician-patient communication skills
4. teach patients how to identify if their device has been recalled
5. train patients what to do in case of a device recall
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.
1. increase patient knowledge about pacemakers (PM) and implantable
cardioverter-defibrillators (ICDs)
2. help patients to identify if their PM or ICD has been interrogated
3. improve patient's physician-patient communication skills
4. teach patients how to identify if their device has been recalled
5. train patients what to do in case of a device recall
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.
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.
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.
Inclusion Criteria:
1. Consecutive patients (beginning with most recent date) who presented to UTMDACC
Preoperative Consultation Clinic from January 1, 2000 to November 15, 2008 with an
implanted pulse generator.
2. English-speaking (Resources to translate materials and provide interviews in Spanish
language or languages other than English are not available for this study).
3. Adult patients 18 years of age or older.
Exclusion Criteria:
1. Patients who fail to consent to participate.
2. Patients with self-report of hearing impairment, sight, or reading impairment that
would hinder ability to complete written surveys
3. Patients who have a second implant
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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