Enhancing Knowledge Implantable Cardioverter-Defibrillators (ICDs)

NCT00822965 | Completed

• 1 other identifier: 2008-0163
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aims of the patient intervention are to:

1. 1.increase patient knowledge about pacemakers (PM) and implantable cardioverter-defibrillators (ICDs)
2. 2.help patients to identify if their PM or ICD has been interrogated
3. 3.improve patient's physician-patient communication skills
4. 4.teach patients how to identify if their device has been recalled
5. 5.train patients what to do in case of a device recall

Conditions

Pacemaker; Implantable Cardioverter-Defibrillators

Keywords

Pacemakers; PM; Implantable cardioverter-defibrillators; ICD; Implantable pulse generators; Educational Interventions

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Patient Knowledge Assessments

Questionnaires + Phone Interview

Other: Questionnaires; Other: Phone Interviews; Behavioral: Educational Packet

Interventions

Questionnaires OTHER

3 sets of questionnaires at the beginning of the study, at 2-months and at 4-months.

Also known as: Survey

Patient Knowledge Assessments

Phone Interviews OTHER

2 follow-up phone interviews.

Patient Knowledge Assessments

Educational Packet BEHAVIORAL

Video or DVD of device information, updates, recalls, on-line resources and benefits of routine follow-up for device(s).

Patient Knowledge Assessments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• English-speaking (Resources to translate materials and provide interviews in Spanish language or languages other than English are not available for this study).
• Adult patients 18 years of age or older.

You may not qualify if:

• Patients who fail to consent to participate.
• Patients with self-report of hearing impairment, sight, or reading impairment that would hinder ability to complete written surveys
• Patients who have a second implant

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Mike Hogg Foundation: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Maria Suarez-Almazor, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 15, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 7, 2016

Record last verified: 2016-01

Locations

US (1)