MDACC Study Summary 2008-0163

Study Summary
No. 2008-0163:.......Other Studies......Maria Suarez-Almazor......General Internal Medicine/Ambulatory Treatment & Emergency Care

Study Summary Title



Study Summary Number:	2008-0163

Study Title:	Patient Knowledge of Pacemaker/Implantable Cardioverter-Defibrillator-Phase II

Physician

New Patient Referral



Name:	Maria Suarez-Almazor	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	General Internal Medicine/Ambulatory Treatment & Emergency Care	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-6486 Contact us about clinical trials

General Information



Disease Group:	Other Studies	Supported By:	Mike Hogg Foundation

Phase of Study:	N/A	Return Visit:	NA. Follow-ups will be conducted by telephone interviews. No return visits to MDACC will be required.

Treatment Agents:	None	Home Care:	NA. No home care treatment required. All patients will be mailed an educational module in the form of written materials and a DVD. Follow-up will be conducted by telephone.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	NA. The educational module will be mailed to the participants and follow-up will be conducted by telephone interviews. The telephone interviews will take about 15 to 20 minutes per call.


Description/ Intervention:	The goal of this research study is to learn if certain learning tools can increase patients' knowledge about pacemakers and implantable cardioverter-defibrillators (for example, how to use these devices safely).

Study Objectives / Outcomes

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 we propose, 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 Status Information



Study Activation / Registration Date:	01/09/2009

IRB Review and Approval Date:	01/09/2009

Study Type:	Behavioral

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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

Links

Registration Number: NCT00822965
Study Information on Clinical Trials Registry (clinicaltrials.gov)