Enhancing Knowledge Implantable Cardioverter-Defibrillators (ICDs)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Mike Hogg Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00822965
First received: January 13, 2009
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: January 2009
Estimated Primary Completion Date: December 2015 (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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822965

Locations
United States, Texas
UT 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 UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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: January 27, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014