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

NCT ID: NCT03234023

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2023-02-05

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome Nutrition Physical Activity Secondary Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

INTERVENTION GROUP

Intervention Type BEHAVIORAL

Offer recommendations of healthy living habits and control of pharmacy administration

CONTROL GROUP

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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INTERVENTION GROUP

Offer recommendations of healthy living habits and control of pharmacy administration

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital A Coruña

OTHER

Sponsor Role lead

Responsible Party

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CARMEN NERI FERNANDEZ POMBO

Research Nurse.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carmen Neri Fernández Pombo, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital A Coruña

Guillermo Aldama López, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital A Coruña

José Manuel Vázquez Rodríguez, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital A Coruña

Raquel Marzoa Rivas, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ferrol

Manuel López Pérez, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ferrol

Marta Lorenzo Carpente, Nurse

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ferrol

Jose Angel Rodriguez Fernández, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital A Coruña

Locations

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University Hospital of Ferrol

Ferrol, A Coruña, Spain

Site Status

University Hospital of A Coruña

A Coruña, Galicia, Spain

Site Status

Countries

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Spain

References

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Fernandez-Pombo CN, Aldama-Lopez G, Lorenzo-Carpente M, Lopez-Perez M, Marzoa-Rivas R, Rodriguez-Fernandez JA, Vazquez-Rodriguez JM. A Remote Nursing-Guided Secondary Prevention Programme in Acute Coronary Syndrome. The SPRING Randomised Controlled Trial. J Adv Nurs. 2025 May 15. doi: 10.1111/jan.17046. Online ahead of print.

Reference Type DERIVED
PMID: 40372009 (View on PubMed)

Other Identifiers

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SPRING

Identifier Type: OTHER

Identifier Source: secondary_id

2017/101

Identifier Type: -

Identifier Source: org_study_id