Secondary PRevention in Cardiovascular Disease by a Nursing Guided Program (SPRING)

Not Applicable

Completed

• Conditions: Nutrition; Acute Coronary Syndrome; Secondary Prevention; Physical Activity
• Interventions: Behavioral: INTERVENTION GROUP

• Registration Number: NCT03234023
• Lead Sponsor: University Hospital A Coruña

Brief Summary

DESIGN: Controlled clinical trial with single randomization, unmasked, open and multicentric.

CENTERS: University Hospital of A Coruña and University Hospital of Ferrol CONDITION TO STUDY: Acute Coronary Syndrome (ACS). INTERVENTION:monitored outhospital not inhospital supervised. MAIN OBJECTIVE: To determine the incidence of major adverse events (total mortality, new ACS, coronary revascularization, all-cause hospitalization) during the one-year period after hospitalization for ACS.

Detailed Description

The SPRING study aims to learn whether a remote, nurse-guided secondary prevention program reduces adverse events in patients who suffer an infarction during the subsequent one-year period. The SPRING study focuses not only on adverse events but also on the patients' state of life in terms of diet, physical exercise, emotional state, tobacco use, and adherence to medical treatment. Nursing is a profession in charge of preserving the health of patients, which is why the remote secondary cardiovascular prevention program of this study is coordinated by a nurse.

Study Timeline

• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-07-31
• Study Start: 2017-10-01
• Primary Completion: 2023-02-05
• Study Completion: 2023-02-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 484

Inclusion Criteria

• All patients who have suffered an ACS in the health area of A Coruña or Ferrol from the beginning of the study inclusion period until reaching the fixed sample size.
• Ages between 18 and 75 years.
• Patients with ability to read and understand the participation sheet in the study.
• Patients signing informed consent to participate in the study.
• Patients living in the health care area of HUAC or HUF.

Exclusion Criteria

• Patients who are dependent for the Basic Activities of Daily Living (BADL) or who suffer from severe cognitive impairment (which makes reliable anamnesis impossible).
• Patients with a Left Ventricular Ejection Fraction (LVEF) less than or equal to 35%.
• Patients with a NYHA III / IV score and / or the Canadian Cardiovascular Association (CCS) scale of IV.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INTERVENTION GROUP	INTERVENTION GROUP	The participants of this group will follow recommendations of food, physical exercise, control of consumption of drugs and consumption of alcohol and tobacco.

Primary Outcome Measures

Name	Time	Method
major adverse events	1 year	total mortality, new ACS, coronary revascularization, hospitalization for any cause

Secondary Outcome Measures

Name	Time	Method
cardiovascular mortality	1 year	cardiovascular mortality
cardiovascular hospitalization	one year	cardiovascular hospitalization
stroke	1 year	stroke
tobacco	1 year	questionnaire
physical activity	1 year	mets
nutrition	1 year	mediterranean diet
emotion state	1 year	questionnaire

Trial Locations

Locations (2)

University Hospital of A Coruña; 🇪🇸 A Coruña, Galicia, Spain

University Hospital of Ferrol; 🇪🇸 Ferrol, A Coruña, Spain