NCT06490952

Brief Summary

To investigates the influencing factors and the pathways of health behavior in patients after heart valve replacement.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 8, 2024

Status Verified

April 1, 2024

Enrollment Period

10 months

First QC Date

July 1, 2024

Last Update Submit

July 1, 2024

Conditions

Heart Valve DiseasesHealth BehaviorPostoperative Period

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Social support

    At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.

  • Anxiety and depression

    At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.

  • Self-efficacy

    At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.

  • Medication Literacy

    At 1-2 days before discharge, at 1 month after discharge, at 3 month after discharge, at 6 month after discharge.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age ≥ 18 years;
  • VHD diagnosed by echocardiography;
  • Received HVR treatment;
  • able to communicate normally.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

MeSH Terms

Conditions

Heart Valve DiseasesHealth Behavior

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Yanjuan Lin

    Fujian Medical University Union Hospital

    STUDY CHAIR

Central Study Contacts

Yanjuan Lin

CONTACT

+86 591 8621 8336fjxhyjl@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 8, 2024

Study Start

January 1, 2024

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

July 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)