Study of Health Behavior in Patients After Heart Valve Replacement： Longitudinal Studies

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Valve Diseases; Health Behavior; Postoperative Period

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 Type: Observational
• Enrollment (Estimated): 219

Contacts and Locations

• Study Contact: Name: Yanjuan Lin; Phone Number: +86 591 8621 8336; Email: fjxhyjl@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Yanjuan Lin, MD; Phone Number: +86 591 8621 8336; Email: fjxhyjl@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing postoperative heart valve replacement were selected for the study.

Description

Inclusion Criteria:

1. Age ≥ 18 years;
2. VHD diagnosed by echocardiography;
3. Received HVR treatment;
4. able to communicate normally.

Exclusion Criteria:

1. Those with a conscious disorder or mental illness;
2. Those with severe organic diseases or comorbidities;
3. Those with cardiac function class IV;
4. Those who could not complete the questionnaire correctly independently or under the guidance of the researcher.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health behavior	A set of behavioral activities undertaken by an individual to promote or maintain health.	At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social support	Support received by an individual from within a social relationship.	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.	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.	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.	At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital
• Investigators: Study Chair: Yanjuan Lin, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases
• Other Study ID Numbers: 2024KY048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No