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

Physical Activity Clinical Trial

— SPRING  

Official title:

Secondary PRevention in Cardiovascular Diseaseby a Nursing Guided Program. SPRING Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03234023
• Other study ID #: 2017/101
• Secondary ID: SPRING
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: February 5, 2023

Study information

• Verified date: January 2024
• Source: University Hospital A Coruña
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: February 5, 2023
• Est. primary completion date: February 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• All patients who have suffered an ACS in the health area of A Coruña 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.
• Patients who possess and know how to operate with a smart mobile phone (Smartphone type).

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Neoplasm Metastasis
• Nutrition
• Physical Activity
• Secondary Prevention

Intervention

Behavioral:
• INTERVENTION GROUP
Offer recommendations of healthy living habits and control of pharmacy administration

Locations

Country	Name	City	State
Spain	University Hospital of A Coruña	A Coruña	Galicia
Spain	University Hospital of Ferrol	Ferrol	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital A Coruña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major adverse events	total mortality, new ACS, coronary revascularization, hospitalization for any cause	1 year
Secondary	cardiovascular mortality	cardiovascular mortality	1 year
Secondary	cardiovascular hospitalization	cardiovascular hospitalization	one year
Secondary	stroke	stroke	1 year
Secondary	tobacco	questionnaire	1 year
Secondary	physical activity	mets	1 year
Secondary	nutrition	mediterranean diet	1 year
Secondary	emotion state	questionnaire	1 year