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Clinical Trial Summary

The study aim is to evaluate the influence of the pre-surgical and post-surgical nursing consultation on the quality indicators (waiting times, patient satisfaction, admission times, hospital readmission, mortality, intrahospital complications and nosocomial infections) in operated patients on percutaneous valvular heart disease treatment. Design of the study is a randomized clinical trial with simple random sampling that will randomized the patients at control group ( pre-surgical consultation without follow-up ) and intervention group (pre-surgical consultation and a follow-up face-to-face consultation a month after the intervention and telephone consultation at one year), Study area will be at the Hemodynamic Unit of the Hospital de la Santa Creu i Sant Pau and the study population are chosen patients for percutaneous valvular intervention who attend the pre-surgical consultation at our center. Dependent variable will be the indicators cited in the study aim and the independent variable will be the pre-surgical and post-surgical consultation. In pre-surgical consultation will be done a patient recruitment and will collect sociodemographic and clinical data. at patient will be done an individualized interview with an Ad-Hoc questionnaire and to collect fragility level of study and level of planned connections. In the subsequent follow-up, the intervening group will attend the consultation designed and collect satisfaction and quality indicators. The control group will respond by phone to your questions about the study. Sample size has been calculated in 194 to be distributed equally in both groups.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05179278
Study type Interventional
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Status Recruiting
Phase N/A
Start date February 25, 2021
Completion date February 1, 2024

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