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Enhancing Knowledge Implantable Cardioverter-Defibrillators (ICDs)

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ClinicalTrials.gov Identifier: NCT00822965
Recruitment Status : Completed
First Posted : January 15, 2009
Last Update Posted : January 7, 2016
Sponsor:
Collaborator:
Mike Hogg Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment
Pacemaker Implantable Cardioverter-Defibrillators Other: Questionnaires Other: Phone Interviews Behavioral: Educational Packet

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Patient Knowledge of Pacemaker/Implantable Cardioverter-Defibrillator-Phase II
Study Start Date : January 2009
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).




Primary Outcome Measures :
  1. Patient knowledge about pacemakers (PM) and implantable cardioverter-defibrillators (ICDs) [ Time Frame: Total knowledge score evaluated at baseline and at 2-month and 4-month post educational intervention. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients presented to UTMDACC Preoperative Consultation Clinic from January 1, 2000 to November 15, 2008 with an implanted pulse generator.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822965


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Mike Hogg Foundation
Investigators
Principal Investigator: Maria Suarez-Almazor, MD, PhD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00822965     History of Changes
Other Study ID Numbers: 2008-0163
First Posted: January 15, 2009    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016

Keywords provided by M.D. Anderson Cancer Center:
Pacemakers
PM
Implantable cardioverter-defibrillators
ICD
Implantable pulse generators
Educational Interventions