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

Primary Purpose

Acute Coronary Syndrome, Nutrition, Physical Activity

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
INTERVENTION GROUP
Sponsored by
University Hospital A Coruña
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 30%.
  • Patients with a NYHA III / IV score and / or the Canadian Cardiovascular Association (CCS) scale of IV.

Sites / Locations

  • University Hospital of Ferrol
  • University Hospital of A Coruña

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

INTERVENTION GROUP

CONTROL GROUP

Arm Description

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

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

Outcomes

Primary Outcome Measures

major adverse cardiac events
(total mortality, new ACS, coronary revascularization, hospitalization for any cause)

Secondary Outcome Measures

Full Information

First Posted
July 25, 2017
Last Updated
October 3, 2022
Sponsor
University Hospital A Coruña
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1. Study Identification

Unique Protocol Identification Number
NCT03234023
Brief Title
Secondary PRevention in Cardiovascular Disease by a Nursing Guide Program (SPRING)
Acronym
SPRING
Official Title
Secondary PRevention in Cardiovascular Diseaseby a Nursing Guide Program. SPRING Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
February 5, 2023 (Anticipated)
Study Completion Date
February 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital A Coruña

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 not supervised. MAIN OBJECTIVE: To determine the incidence of major adverse cardiac events, MACE (total mortality, new ACS, coronary revascularization, all-cause hospitalization) during the one-year period after hospitalization for ACS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Nutrition, Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
484 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INTERVENTION GROUP
Arm Type
Active Comparator
Arm Description
The participants of this group will follow recommendations of food, physical exercise, control of consumption of drugs and consumption of alcohol and tobacco.
Arm Title
CONTROL GROUP
Arm Type
No Intervention
Arm Description
The participants of this group are submitted to the standard intervention.
Intervention Type
Behavioral
Intervention Name(s)
INTERVENTION GROUP
Intervention Description
Offer recommendations of healthy living habits and control of pharmacy administration
Primary Outcome Measure Information:
Title
major adverse cardiac events
Description
(total mortality, new ACS, coronary revascularization, hospitalization for any cause)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 30%. Patients with a NYHA III / IV score and / or the Canadian Cardiovascular Association (CCS) scale of IV.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Neri Fernández Pombo, PhD
Organizational Affiliation
University Hospital A Coruña
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Ferrol
City
Ferrol
State/Province
A Coruña
ZIP/Postal Code
15405
Country
Spain
Facility Name
University Hospital of A Coruña
City
A Coruña
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data of the participants can not be used by other researchers

Learn more about this trial

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

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