The Effect of Education and Follow-up Program in Patients Undergoing TAVI

Dokuz Eylül University (DEU)

Status: Completed

Conditions: Aortic Stenosis; Nursing Caries

Treatments: Other: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT05625269

2021/26-11

Details and patient eligibility

About

Aortic stenosis is a progressive disease that affects approximately 3% of adults aged 75 and over. If left untreated, the mortality rate of aortic stenosis, which becomes symptomatic in a short time, is 50% in the first year, while this rate rises to 90% within 5 years.

Surgical treatment of aortic stenosis has been proven to reduce symptoms and increase survival. Although surgical treatment is considered the gold standard, 30% of elderly patients cannot undergo surgery due to left ventricular dysfunction and comorbidities. The search for new methods with a low-risk rate and a more comfortable post-procedure process has begun. For this purpose, Cribier et al. Transcatheter aortic valve implantation (TAVI) was developed in 2002 as an important alternative to surgical aortic valve placement. The TAVI method; is the procedure of inserting a bioprosthetic aortic valve into the heart using the catheter method without open heart surgery.

Although transcatheter aortic valve implantation is more tolerable than surgery, it has certain complications. According to the Valve Academic Research Consortium (VARC-3), common post-procedural complications are; stroke, myocardial infarction, bleeding, major vascular complications, and acute kidney injury. Nursing-specific care problems are stated as bleeding, infection, pain, decrease in cardiac output, and sleep problems. Many factors, such as the high risk of patients undergoing TAVI, the complexity of the procedure, and the complications that may develop after the procedure, require that the nursing care to be applied be specific and individualized to the TAVI procedure. It is very important to understand the experiences of the patients to effectively carry out this special care to be applied before and after TAVI. It is known that being aware of the experiences and needs will contribute positively to the care and treatment of future patients. Instens et al. stated that experiences can be reached by examining perspectives in depth rather than clinical studies or records. In this regard, Baumbusch et al. in their qualitative design study; It has been revealed that TAVI patients cannot manage their care after the procedure because of their age and comorbidities, there is a difference between their expectations and reality, and they need support in terms of information. In another study, the post-TAVI process was defined as a balance between the struggle for life and hope, and the importance of the support of health professionals during the process was emphasized. For these reasons, TAVI patients need nursing care support and information in terms of post-procedure disease management. The most important component of successful disease management is to increase the participation of the individual in his health. In this direction, nurse-led training and counseling programs are the leading methods that will increase the participation of patients in their health management, and research on this subject has been increasing in recent years. Jiang et al. In their study on patients with myocardial infarction, it was found that a nurse-led training and counseling program increased the quality of life and risk factor control. Boyne et al. In their study of heart failure patients, it was revealed that the knowledge, self-care, and self-efficacy of the patients increased after the intervention.

Despite growing evidence for the benefits of nurse-led education and counseling programs, no studies have been found with TAVI patients who might need this intervention the most. The aim of this study; is to examine the effect of education and follow-up program on quality of life, self-care, treatment compliance and hospital readmission in patients who underwent TAVI.

Enrollment: 60 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Transcatheter aortic valve implantation will be performed
• New York Health Association class II or III
• Mini-Mental Assessment test score ≥ 24
• Reachable by phone
• Volunteer to participate in the research
• Patients who can understand and speak Turkish

Exclusion criteria

• Stroke before and after the procedure
• Patients with kidney failure (to a level that requires dialysis treatment)
• Cancer (chemotherapy, radiotherapy)
• Chronic obstructive pulmonary disease (at a level that will require ventilation support)
• Severe hearing impairment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Education and follow-up group

Experimental group

Description:

Patients in the intervention group will be given training on the procedure and home care process on the first day of hospitalization and the day before discharge. Afterwards, patients will be followed up by phone at intervals of two weeks. The purpose of telephone monitoring is to question adherence to treatment, to identify and change barriers, to apply counseling and to control symptoms.

Treatment:

Other: Education

Control group

No Intervention group

Description:

The control group will be given the standard care applied in the clinic, and the patients of this group will be given training after the research is completed.