Aortic StenosisNCT05625269
The Effect of Education and Follow-up Program in Patients Undergoing TAVI
A study testing Education in people with Aortic Stenosis and Nursing Caries, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Stenosis, Nursing Caries
- What is being tested?
- Education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2022to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education and Follow-up Program in Patients Undergoing Transcatheter Aortic Valve Implantation
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.
Read more
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
- Being tested
- Education
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Education and follow-up group | Experimental | 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. Receives: Other: Education |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D (European QOL) Health Related Quality of Life Questionnaire
The EQ-5D scale was developed by the European Quality of Life (EuroQol) Working Group in 1990 for use in evaluative studies such as drug studies and policy research, and was revised in 1993. The EQ-5D defines health in terms of five sub-dimensions (mobility, self-care, general activities, pain/discomfort, and anxiety/depression) in a three-level structure as "no problem, moderately problematic, and severely problematic". An index score ranging from -0.59 to 1 is calculated from the 5 dimensions of the scale. In the score function, a value of 0 indicates death, a value of 1 indicates perfect health, while negative values indicate unconsciousness, being confined to a bed, etc. shows the situations.
Measured: 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.
European Heart Failure Self-Care Behaviors Scale
This scale was developed by Jaarsma et al. in 2003. The scale applied to measure the self-care behaviors of patients with heart failure has been determined as a scale that can be applied by the patients themselves, which does not require separate training and results in a short time. The scale consists of 12 items that include diagnosing symptoms related to heart failure such as edema, dyspnea, and self-care practices such as salt restriction or continuation of drug therapy. In the scoring of the scale, the participants are asked to choose one of the options for each item: I completely agree (1), agree (2), undecided (3), disagree (4), and completely disagree (5). The total score that can be obtained from the scale varies between 12-60. A high total score indicates low self-care, and a low score indicates high self-care.
Measured: 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.
Medication Adherence Report Scale
The Medication Adherence Report Scale developed by Horne and Hankins (2001) to assess drug compliance, is a generic scale and can be customized according to the type of disease. Adaptations of the scale of many illnesses such as hypertension, diabetes, rheumatoid arthritis, asthma, chronic obstructive pulmonary disease, bipolar mood disorder, inflammatory bowel disease, hyperlipidemia and chronic pain are available in the literature. Participants are asked to indicate the frequency of occurrence of each of the five expressions. The scale is evaluated on a 5-point Likert-type scale with 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = very often. The total test score is obtained by summing the scores obtained from the items. Scores from the scale range from 5 to 25
Measured: 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.
Questionnaire
Hospital Readmission
Measured: Hospitalization of TAVI patients due to cardiac causes within the first month after discharge will be considered as readmission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start18 Dec 2022
- Primary completion1 Oct 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu AKBABA, Dokuz Eylul University
- Investigators
- Hatice MERT, Prof. Dr., Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625269
- Sponsor's protocol ID
- 2021/26-11
- Status last verified
- Mar 2024
- First submitted
- 7 Nov 2022
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education and Follow-up Program in Patients Undergoing Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT05625269
- Acronym / sponsor ID
- 2021/26-11
- Conditions
- Aortic Stenosis, Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 18 Dec 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 22 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Education and follow-up group | Experimental | Other: EducationPatients 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationThe 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. | Other | Education and follow-up group |
Primary outcome
EQ-5D (European QOL) Health Related Quality of Life Questionnaire
Time frame: 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.
The EQ-5D scale was developed by the European Quality of Life (EuroQol) Working Group in 1990 for use in evaluative studies such as drug studies and policy research, and was revised in 1993. The EQ-5D defines health in terms of five sub-dimensions (mobility, self-care, general activities, pain/discomfort, and anxiety/depression) in a three-level structure as "no problem, moderately problematic, and severely problematic". An index score ranging from -0.59 to 1 is calculated from the 5 dimensions of the scale. In the score function, a value of 0 indicates death, a value of 1 indicates perfect health, while negative values indicate unconsciousness, being confined to a bed, etc. shows the situations.
European Heart Failure Self-Care Behaviors Scale
Time frame: 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.
This scale was developed by Jaarsma et al. in 2003. The scale applied to measure the self-care behaviors of patients with heart failure has been determined as a scale that can be applied by the patients themselves, which does not require separate training and results in a short time. The scale consists of 12 items that include diagnosing symptoms related to heart failure such as edema, dyspnea, and self-care practices such as salt restriction or continuation of drug therapy. In the scoring of the scale, the participants are asked to choose one of the options for each item: I completely agree (1), agree (2), undecided (3), disagree (4), and completely disagree (5). The total score that can be obtained from the scale varies between 12-60. A high total score indicates low self-care, and a low score indicates high self-care.
Medication Adherence Report Scale
Time frame: 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.
The Medication Adherence Report Scale developed by Horne and Hankins (2001) to assess drug compliance, is a generic scale and can be customized according to the type of disease. Adaptations of the scale of many illnesses such as hypertension, diabetes, rheumatoid arthritis, asthma, chronic obstructive pulmonary disease, bipolar mood disorder, inflammatory bowel disease, hyperlipidemia and chronic pain are available in the literature. Participants are asked to indicate the frequency of occurrence of each of the five expressions. The scale is evaluated on a 5-point Likert-type scale with 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = very often. The total test score is obtained by summing the scores obtained from the items. Scores from the scale range from 5 to 25
Questionnaire
Time frame: Hospitalization of TAVI patients due to cardiac causes within the first month after discharge will be considered as readmission.
Hospital Readmission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatice MERT, Prof. Dr. study director
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Aortic Stenosis and Nursing Caries, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ-5D (European QOL) Health Related Quality of Life Questionnaire (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.