Education Program for Cardiac Patients

Not Applicable

Completed

• Conditions: Percutaneous Coronary Intervention; Coronary Artery Disease
• Interventions: Behavioral: Usual care; Behavioral: educational program+telephone follow up

• Registration Number: NCT01341093
• Lead Sponsor: University of Sao Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-22
• Study First Posted: 2011-04-25
• Study Start: 2011-08
• Primary Completion: 2012-12
• Study Completion: 2013-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-14
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual care	Usual care	-
educational program+telephone follow up	educational program+telephone follow up	-

Primary Outcome Measures

Name	Time	Method
change from baseline in perceived health status at six months	baseline and 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.

Secondary Outcome Measures

Name	Time	Method
change from baseline in treatment adherence at six months	baseline and 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.
change from baseline in self-efficacy at six months	baseline and 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.
change from baseline in anxiety and depression at six months	baseline and 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.

Trial Locations

Locations (1)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo; 🇧🇷 Ribeirão Preto, São Paulo, Brazil