Education Program for Cardiac Patients

Study Overview
=================
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.

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

Conditions
-----------------
Percutaneous Coronary Intervention, Coronary Artery Disease

Intervention / Treatment
-----------------
* Behavioral: educational program+telephone follow up
* Behavioral: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: usual care<br> | Behavioral: Usual care<br>* 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.<br>|
| Experimental: educational program+telephone follow up<br> | Behavioral: educational program+telephone follow up<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |