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

University Hospital A Coruña

Status: Completed

Conditions: Physical Activity; Acute Coronary Syndrome; Nutrition; Secondary Prevention

Treatments: Behavioral: INTERVENTION GROUP

Study type: Interventional

Funder types: Other

Identifiers

NCT03234023

SPRING (Other Identifier)

2017/101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 484 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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484 participants in 2 patient groups

INTERVENTION GROUP

Active Comparator group

Description:

The participants of this group will follow recommendations of food, physical exercise, control of consumption of drugs and consumption of alcohol and tobacco.

Treatment:

Behavioral: INTERVENTION GROUP

CONTROL GROUP

No Intervention group

Description:

The participants of this group are submitted to the standard intervention.