Heart Valve DiseasesNCT06490952
Study of Health Behavior in Patients After Heart Valve Replacement： Longitudinal Studies
An observational study of Heart Valve Diseases and Health Behavior, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
To investigates the influencing factors and the pathways of health behavior in patients after heart valve replacement. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Valve Diseases, Health Behavior, Postoperative Period
- How many people
- 219 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Dec 2024
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing postoperative heart valve replacement were selected for the study.
Who may be able to join
- Age ≥ 18 years;
- VHD diagnosed by echocardiography;
- Received HVR treatment;
- able to communicate normally.
Who cannot join
- Those with a conscious disorder or mental illness;
- Those with severe organic diseases or comorbidities;
- Those with cardiac function class IV;
- Those who could not complete the questionnaire correctly independently or under the guidance of the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Yanjuan Lin, MD, +86 591 8621 8336, fjxhyjl@163.com
About this study
Official title: Study on the Influencing Factors and the Pathways of Health Behavior in Patients After Heart Valve Replacement
To investigates the influencing factors and the pathways of health behavior in patients after heart valve replacement.
Read the detailed description
Currently, the prevalence of heart valve disease is 2.0% to 13.2%, and heart valve replacement is the most important treatment to address heart valve disease. Heart valve replacement surgery is highly traumatic and risky, and the recovery of physiological, psychological, and social functions of postoperative patients is challenging, affecting the recovery process of patients. Healthy behavior is a lifestyle that can effectively reduce risk factors for adverse events and complications at the physiological, psychological, and social levels to slow disease progression, which can help promote patient recovery and improve prognosis. Therefore, this study investigates and analyzes the health behaviors of postoperative patients in different periods, explores their influencing factors and analyzes their pathways of action.
- Conditions
- Heart Valve Diseases, Health Behavior, Postoperative Period
- Medical subject headings
- Heart Valve Diseases, Health Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Health behavior
A set of behavioral activities undertaken by an individual to promote or maintain health.
Measured: At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.
Secondary outcomes (4)
Social support
Support received by an individual from within a social relationship.
Measured: At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.
Anxiety and depression
Measuring the psychological situation.
Measured: At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.
Self-efficacy
Measure the level of self-confidence.
Measured: At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.
Medication Literacy
Measuring medication-taking skills.
Measured: At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Jan 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanjuan Lin, Study chair, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490952
- Sponsor's protocol ID
- 2024KY048
- Status last verified
- Apr 2024
- First submitted
- 1 Jul 2024
- Last updated
- 8 Jul 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Influencing Factors and the Pathways of Health Behavior in Patients After Heart Valve Replacement
- ClinicalTrials.gov ID
- NCT06490952
- Acronym / sponsor ID
- 2024KY048
- Conditions
- Heart Valve Diseases, Health Behavior, Postoperative Period
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 8 Jul 2024 (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.
To investigates the influencing factors and the pathways of health behavior in patients after heart valve replacement.
Detailed description
Currently, the prevalence of heart valve disease is 2.0% to 13.2%, and heart valve replacement is the most important treatment to address heart valve disease. Heart valve replacement surgery is highly traumatic and risky, and the recovery of physiological, psychological, and social functions of postoperative patients is challenging, affecting the recovery process of patients. Healthy behavior is a lifestyle that can effectively reduce risk factors for adverse events and complications at the physiological, psychological, and social levels to slow disease progression, which can help promote patient recovery and improve prognosis. Therefore, this study investigates and analyzes the health behaviors of postoperative patients in different periods, explores their influencing factors and analyzes their pathways of action.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing postoperative heart valve replacement were selected for the study.
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- VHD diagnosed by echocardiography;
- Received HVR treatment;
- able to communicate normally.
Key exclusion criteria (4 listed)
- Those with a conscious disorder or mental illness;
- Those with severe organic diseases or comorbidities;
- Those with cardiac function class IV;
- Those who could not complete the questionnaire correctly independently or under the guidance of the researcher.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health behavior
Time frame: At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.
A set of behavioral activities undertaken by an individual to promote or maintain health.
4 secondary outcomes
Social support
Time frame: At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.
Anxiety and depression
Time frame: At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.
Self-efficacy
Time frame: At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.
Medication Literacy
Time frame: At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 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.
Yanjuan Lin study chair
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Diseases and Health Behavior, run by Fujian Medical University Union Hospital at 1 site in China.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Jul 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanjuan Lin (+86 591 8621 8336, fjxhyjl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health behavior (time frame: At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.). 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 8 Jul 2024.