Educational Program with Telephone Follow-up for patients submitted to percutaneous coronary intervention: randomized controlled clinical trial

Author(s)

Rejane Kiyomi Furuya

• Document type: Doctoral Thesis
• Press: São Paulo.
• Institution: Universidade de São Paulo (USP). Escola de Enfermagem (EE/SBD)
• Defense date: 2013-08-22

Examining board members

Lidia Aparecida Rossi; Márcia Aparecida Ciol; Rosana Aparecida Spadoti Dantas; Jeanne Marie Hoffman; Roberta Cunha Matheus Rodrigues

• Advisor: Lidia Aparecida Rossi

Abstract

Introduction. Percutaneous coronary intervention (PCI) is one of the treatments available for coronary artery disease (CAD) patients. This intervention should be accompanied by other therapeutic interventions with the aim of reducing disabilities and the risk of new coronary events, controlling the progression of the disease, and improving the quality of life. These interventions comprise the secondary prevention of CAD and are mainly related to lifestyle changes, aiming to manage risk factors for CAD. Health professionals have used telephone follow-up to monitor patients and families in the delivery of care to different chronic conditions, including CAD. Objective. To develop, to implement and to assess an educational program with telephone follow-up, during four months after hospital discharge, for patients submitted to PCI, with the aim of improving the perceived health status, self-efficacy, medication adherence and emotional status of these patients, as well as to compare outcomes of the Educational Program with routine hospital services. Method. Randomized controlled clinical trial, developed at the Ribeirão Preto Medical School Hospital das Clínicas, Brazil. The study sample included patients who had been submitted to their first PCI between August 2011 and June 2012. The participants were randomly assigned to the Educational Program with Telephone Follow-up (intervention group [IG]: 30 participants) and routine care (control group [CG]: 30 participants). The theoretical framework that supported the Educational Program applied in this study was the self-efficacy construct in Albert Bandura\'s Social Cognitive Theory. The main outcome was the perceived health status, assessed using the Medical Outcomes Survey 36- Item Short Form (SF-36); and the secondary outcomes were self-efficacy, assessed using the Perceived General Self-Efficacy Scale; medication adherence, assessed using the Medida de Adesão ao Tratamento (MAT); and the emotional status (anxiety and depression), assessed using the Hospital Anxiety and Depression Scale (HADS). The outcomes were evaluated before the procedure (T0) and six months after the PCI (T1). Descriptive analysis was applied, as well as variance analysis for repeated measures, the chi-square test and relative risk, with the confidence interval set at 95%. Significance was set at 0.05. This clinical trial was registered under number NCT01341093. Results. In the assessment of the perceived health status, with significance set at 0.05, no interaction (time and group) or group was statistically significant, but interaction between time and group was verified, with significance levels ranging between 0.05 and 0.10 in the Mental Component Summary (p=0.08) and in the Emotional Aspects domain (p=0.07); as well as improvement in the Social Aspects domain for the IG (p=0.10). In the assessment of self-efficacy, no differences were found between the groups or times. Many participants indicated medication adherence at T0 and T1 in the two groups (more than 90% initially and during the follow-up). In the assessment of anxiety levels six months after the PCI, the number of non-cases of anxiety increased in IG and dropped in CG, with a statistically significant association between the variables (p=0.04). At the end of the monitoring, the relative risk of being a non-case of anxiety in IG corresponded to 1.6 (95% confidence interval [CI]=1.0 - 2.4) when compared to CG. As regards depression, no evidence was found of differences in the percentage of patients non-case of depression between the groups (IG and CG), neither during hospitalization nor during follow-up. At the end of the follow-up, the relative risk of IG being a non-case of depression corresponded to 0.8 (95% confidence interval [CI]= 0.6 - 1.1) when compared to CG. Conclusion. The Educational Program with Telephone Follow-up is a promising intervention to improve the perceived health status and reduce the anxiety of patients submitted to PCI. The intervention may need further development to influence self-efficacy and depression. Self-efficacy and medication adherence instruments need improvements (AU)

• FAPESP's process: 10/19761-3 - Education program for patients after coronary artery bypass grafting: impact on perceived health status and treatment adherence
• Grantee: Rejane Kiyomi Furuya
• Support Opportunities: Scholarships in Brazil - Doctorate (Direct)