Education Program for Cardiac Patients

May 14, 2014 updated by: Rejane Kiyomi Furuya, University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14048900
        • Hospital Das Clinicas Da Faculdade De Medicina De Ribeirao Preto da Universidade de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: usual care
Behavioral: 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.
Experimental: educational program+telephone follow up
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in perceived health status at six months
Time Frame: 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.
baseline and six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in treatment adherence at six months
Time Frame: 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.
baseline and six months
change from baseline in self-efficacy at six months
Time Frame: 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.
baseline and six months
change from baseline in anxiety and depression at six months
Time Frame: 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.
baseline and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Rejane K. Furuya, PhDCandidate, University of São Paulo at Ribeirão Preto College of Nursing
  • Study Chair: Lidia A. Rossi, PhD, University of São Paulo at Ribeirão Preto College of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

April 15, 2011

First Submitted That Met QC Criteria

April 22, 2011

First Posted (Estimate)

April 25, 2011

Study Record Updates

Last Update Posted (Estimate)

May 15, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/19761-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Usual care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe