Clinical trial NCT05625269: The Effect of Education and Follow-up Program in Patients Undergoing TAVI
Official title: The Effect of Education and Follow-up Program in Patients Undergoing Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Nursing Caries
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: EQ-5D (European QOL) Health Related Quality of Life Questionnaire
timeFrame: The scale will be applied on the first day of hospitalization, in the 1st and 3rd months to show the change in the patient's quality of life over the months.
measure: European Heart Failure Self-Care Behaviors Scale
timeFrame: The scale will be applied on the first day of hospitalization, in the 1st and 3rd months to show the change in the patient's self care over the months.
measure: Medication Adherence Report Scale
timeFrame: The scale will be applied on the first day of hospitalization, in the 1st and 3rd months to show the change in the patient's medication adherence over the months.
measure: Questionnaire
timeFrame: Hospitalization of TAVI patients due to cardiac causes within the first month after discharge will be considered as readmission.
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Hospital of Dokuz Eylul University
Study officials:
affiliation: Dokuz Eylul University
name: Hatice MERT, Prof. Dr.
role: STUDY_DIRECTOR
References: