Education Program for Cardiac Patients

Coronary Artery Disease Clinical Trial

Official title:

Educational Program With Telephone Follow-up for Patients After Percutaneous Coronary Intervention: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341093
• Other study ID #: 2010/19761-3
• Status: Completed
• Phase: N/A
• First received: April 15, 2011
• Last updated: May 14, 2014
• Start date: August 2011
• Est. completion date: October 2013

Study information

• Verified date: May 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to elaborate an educative program that includes telephone follow-up and assess its impact on the perceived health status of patients submitted to percutaneous coronary intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (18 years or more) of both sexes

• Being submitted to the first coronary artery bypass graft surgery between April 2011 and July 2012

• Having a properly functioning residential phone line

Exclusion Criteria:

• No cognitive condition to participate (assessed through the Mini-Mental State Examination - MMSE)

• Illiterate participants who did not reach the minimum score 13 on the MMSE

• Participants with one to seven years of education who did not reach the minimum score 18 on the MMSE

• Participants with eight or more years of education who did not reach the minimum of 26 points on the MMSE

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Behavioral:
• educational program+telephone follow up
Patients will participate in the educational program with telephone follow-up, the education program will initiate in preoperative period and will continue for six months.
• Usual care
Patients will receive orientations about the surgery and the rehabilitation by health professionals, especially in the discharge. And will have return for evaluation scheduled by health professionals.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in perceived health status at six months	The questionnaire "Medical Outcomes Survey 36 - Item Short-Form" developed by Ware and Sherboune (1992) will be used to collect the data at baseline and at six months.	baseline and six months	Yes
Secondary	change from baseline in treatment adherence at six months	The questionnaire "Medida de adesão ao tratamento (MAT)" developed by Delgado and Lima (2001) will be used to collect the data related to the pharmacological adherence at baseline and at six months.	baseline and six months	Yes
Secondary	change from baseline in self-efficacy at six months	The questionnaire "General Self-Efficacy Scale" developed by Schwarzer and Jerusalem (1995) will be used to collect the data at baseline and at six months.	baseline and six months	Yes
Secondary	change from baseline in anxiety and depression at six months	The questionnaire "Hospital Anxiety and Depression Scale (HADS)" developed by Zigmond and Snaith (1983) will be used to collect the data at baseline and at six months.	baseline and six months	Yes