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Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings

NCT02554006 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2018-05-02

No results posted yet for this study

Summary

A single-center, randomized trial of admitted patients with ischemic heart disease receiving percutaneous coronary intervention and stent implantation will be conducted at University Hospital of Ferrara. Patients will be randomized to either the control (standard care) or the bundle group in which patients will receive counseling regarding dual antiplatelet therapy management, advantages and side effects, screening for depression or anxiety, standardized education. The primary endpoint will be the difference in the quality of life as assessed by EQ-5D questionnaire.

Conditions

  • Myocardial Ischemia
  • Hemorrhage
  • Quality of Life
  • Platelet Aggregation Inhibitors

Interventions

BEHAVIORAL

good clinical practice

education from physician regarding dual antiplatelet therapy as part of the routine discharge process

BEHAVIORAL

bundle group

visits and materials describing advantages and side effects of dual antiplatelet therapy and their management

Sponsors & Collaborators

  • University Hospital of Ferrara

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-03-31
Completion
2017-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02554006 on ClinicalTrials.gov