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Completed

NCT Number: NCT01341093

Education Program for Cardiac Patients

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.

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Key information

Conditions

Percutaneous Coronary Intervention Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Ribeirão Preto, São Paulo, 14048900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

educational program+telephone follow up

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Apr 25, 2011
Registry last updated
May 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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