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

NCT ID: NCT05625269

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-18
• Study Completion Date: 2023-12-15

Brief Summary

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.

Conditions

Aortic Stenosis; Nursing Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Education and follow-up group

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.

Group Type: EXPERIMENTAL

Education

Intervention Type: OTHER

The first session of the individual training will be held for the patients in the intervention group on the first day of the service hospitalization, covering the issues related to the procedure and the hospital process. Afterwards, the second session of individual education will be held the day before discharge on issues related to the patient's home care, such as treatment site care, nutrition, exercise, medication and symptom management. In addition to the patients, their families will also participate in the training sessions. The training will be given face-to-face in a quiet environment to increase intelligibility in patients' rooms. The patients will be given a booklet and magnet prepared by the researcher in addition to the oral explanation.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education

The first session of the individual training will be held for the patients in the intervention group on the first day of the service hospitalization, covering the issues related to the procedure and the hospital process. Afterwards, the second session of individual education will be held the day before discharge on issues related to the patient's home care, such as treatment site care, nutrition, exercise, medication and symptom management. In addition to the patients, their families will also participate in the training sessions. The training will be given face-to-face in a quiet environment to increase intelligibility in patients' rooms. The patients will be given a booklet and magnet prepared by the researcher in addition to the oral explanation.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Arzu AKBABA

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hatice MERT, Prof. Dr.

Role: STUDY_DIRECTOR

Dokuz Eylul University

Locations

Hospital of Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021/26-11

Identifier Type: -

Identifier Source: org_study_id