Clinical trial NCT03234023: Secondary PRevention in Cardiovascular Disease by a Nursing Guided Program (SPRING)
Official title: A Remote Nursing-Guided Secondary Prevention Programme in Acute Coronary Syndrome. The SPRING Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Nutrition
Physical Activity
Secondary Prevention
Lead sponsor: University Hospital A Coruña
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: major adverse events
timeFrame: 1 year
Secondary outcomes:
measure: cardiovascular mortality
timeFrame: 1 year
measure: cardiovascular hospitalization
timeFrame: one year
measure: stroke
timeFrame: 1 year
measure: tobacco
timeFrame: 1 year
measure: physical activity
timeFrame: 1 year
measure: nutrition
timeFrame: 1 year
measure: emotion state
timeFrame: 1 year
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: University Hospital of Ferrol
state: A Coruña
city: A Coruña
country: Spain
facility: University Hospital of A Coruña
state: Galicia
Study officials:
affiliation: University Hospital A Coruña
name: Carmen Neri Fernández Pombo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital A Coruña
name: Guillermo Aldama López, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital A Coruña
name: José Manuel Vázquez Rodríguez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Ferrol
name: Raquel Marzoa Rivas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Ferrol
name: Manuel López Pérez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Ferrol
name: Marta Lorenzo Carpente, Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital A Coruña
name: Jose Angel Rodriguez Fernández, MD
role: PRINCIPAL_INVESTIGATOR
References: