Enhancing Knowledge Implantable Cardioverter-Defibrillators (ICDs)

January 5, 2016 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Total knowledge score evaluated at baseline and at 2-month and 4-month post educational intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Mike Hogg Foundation

Investigators

  • Principal Investigator: Maria Suarez-Almazor, MD, PhD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 15, 2009

Study Record Updates

Last Update Posted (Estimate)

January 7, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2008-0163

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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