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

A Remote Nursing-Guided Secondary Prevention Programme in Acute Coronary Syndrome. The SPRING Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Acute Coronary Syndrome; Nutrition; Secondary Prevention
• Intervention / Treatment: Behavioral: INTERVENTION GROUP

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 Type: Interventional
• Enrollment (Actual): 484
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • A Coruña
    • Ferrol, A Coruña, Spain, 15405
      • University Hospital of Ferrol
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • University Hospital of A Coruña

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: INTERVENTION GROUP; Offer recommendations of healthy living habits and control of pharmacy administration
No Intervention: CONTROL GROUP; The participants of this group are submitted to the standard intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major adverse events	total mortality, new ACS, coronary revascularization, hospitalization for any cause	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiovascular mortality	cardiovascular mortality	1 year
cardiovascular hospitalization	cardiovascular hospitalization	one year
stroke	stroke	1 year
tobacco	questionnaire	1 year
physical activity	mets	1 year
nutrition	mediterranean diet	1 year
emotion state	questionnaire	1 year

Collaborators and Investigators

• Sponsor: University Hospital A Coruña
• Investigators: Principal Investigator: Carmen Neri Fernández Pombo, PhD, University Hospital A Coruña; Principal Investigator: Guillermo Aldama López, MD, University Hospital A Coruña; Principal Investigator: José Manuel Vázquez Rodríguez, MD, University Hospital A Coruña; Principal Investigator: Raquel Marzoa Rivas, MD, University Hospital Ferrol; Principal Investigator: Manuel López Pérez, MD, University Hospital Ferrol; Principal Investigator: Marta Lorenzo Carpente, Nurse, University Hospital Ferrol; Principal Investigator: Jose Angel Rodriguez Fernández, MD, University Hospital A Coruña

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): February 5, 2023
• Study Completion (Actual): February 5, 2023

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Heart Diseases; Disease; Neoplastic Processes; Myocardial Ischemia; Syndrome; Neoplasm Metastasis; Acute Coronary Syndrome
• Other Study ID Numbers: 2017/101; SPRING (Other Identifier: University Hospital A Coruña)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data of the participants can not be used by other researchers

Drug and device information, study documents

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