Educational program with telephone follow-up for patients undergoing percutaneous coronary intervention: evaluation of impact on perceived health status and adherence to treatment 12 months after the intervention

Abstract

The aims of this project are to assess the long-term results of an Educational Program with Telephone Follow-up for patients submitted to percutaneous coronary intervention (PCI) with the objective of improving self-care; and to compare the results of the Educational Program with the information routinely delivered by the institution. The Educational Program participants (intervention group - IG) will be compared with participants that received usual care (control group - CG), 12 months after PCI. The primary outcome will be the perceived health status, and the secondary outcomes will be: self-efficacy, medication adherence, anxiety, depression, and hospitalizations in 12 months after PCI procedure. Methods: this project aims to continue the follow-up of 60 subjects that participated in a randomized controlled clinical trial, and groups (IG and CG) were compared, considering the primary and secondary outcomes, six months after PCI. The sample will be composed of patients who underwent their first PCI, and who were randomized to participate in an Educational Program, with individual instruction and based on Albert Bandura`s Social Cognitive Theory. Thirty participants were randomized to each group (IG and CG). The IG participants received three booklets during hospitalization, when they underwent PCI, and they also received telephone follow-up after hospital discharge. The telephone calls were made, focusing on clarifying doubts, and reinforcing the orientations received during hospitalization. The telephone follow-up had the objective of motivating self-care, and lifestyle changes, during rehabilitation. The CG participants received usual instructions given by health care providers at the hospital. The group's comparison at six months indicated that the intervention was promising to improve perceived health status, and to reduce patients' anxiety, six months after PCI. However, it is necessary to assess the participants at 12 months. This assessment may confirm the long-term effectiveness of the Educational Program, especially considering the clinical instability of patients with coronary heart disease. The outcomes will be assessed by the following instruments: SF-36 (perceived health status); General Self-Efficacy Scale (self-efficacy), Treatment Adherence Measure (medication adherence), and Hospital Anxiety and Depression Scale -HADS (anxiety and depression). The hospitalizations in 12 months after PCI procedure will be verified by analysis of medical records. Data will be entered and analyzed using Statistical Package for the Social Sciences software (IBM SPSS version 21.0). To assess change in the primary outcome of perceived health status, we will perform a repeated measures analysis of variance, using time (baseline, six months, and 12 months), group (IG and CG), and an interaction of time by group. Similarly, the secondary outcomes of self-efficacy, anxiety, and depression will be analyzed using repeated measures analysis of variance. The outcome medication adherence will be analyzed using Chi-scare test, and the number of hospitalizations in 12 months after PCI procedure will be analyzed using Student t test for independent samples. Significance level will be set at 0.05.