Enhancing Knowledge Implantable Cardioverter-Defibrillators (ICDs)

Pacemaker Clinical Trial

Official title:

Patient Knowledge of Pacemaker/Implantable Cardioverter-Defibrillator-Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822965
• Other study ID #: 2008-0163
• Status: Completed
• Phase: N/A
• First received: January 13, 2009
• Last updated: January 5, 2016
• Start date: January 2009
• Est. completion date: January 2015

Study information

• Verified date: January 2016
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Implantable Cardioverter-Defibrillators
• Pacemaker

Intervention

Other:
• Questionnaires
3 sets of questionnaires at the beginning of the study, at 2-months and at 4-months.
• 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).

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Mike Hogg Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient knowledge about pacemakers (PM) and implantable cardioverter-defibrillators (ICDs)		Total knowledge score evaluated at baseline and at 2-month and 4-month post educational intervention.	No

External Links

•   University of Texas MD Anderson Cancer Center Website