Telemonitoring System for Improving Continuity of Care in Patients With Chronic Coronary Syndrome (TELSINCORC)

NCT05875311 | Recruiting

• 1 other identifier: TRISA-2023
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

In a randomized clinical trial, a comprehensive telerehabilitation system with a prolonged follow-up strategy demonstrated superiority over a control group with centre-based cardiac rehabilitation in terms of physical activity, VO2 max, adherence to a Mediterranean diet, lipid particle profile and cost-effectiveness. The aim of this study is to demonstrate an extension of the benefit to patients with chronic coronary syndrome in primary care.

Conditions

Chronic Coronary Syndrome

Keywords

mobile health; Chronic coronary syndrome; cardiac rehabilitation; telerehabilitation; secondary prevention; exercise

Outcome Measures

Primary Outcomes (1)

• The 6-min walk distance (6MWD)

  Meters (m)

  10 months

Secondary Outcomes (32)

• Maximal heart rate in the six minute walk test

  10 months

• Total cholesterol

  10 months

• Glycosylated haemoglobin

  10 months

• Weight

  10 months

• Waist circumference

  10 months

Study Arms (2)

telemonitoring

EXPERIMENTAL

Patients in the intervention group will come to the ambulatory centre 2 times, undergoing mobile application training and the same educational talks as in the control group. Subsequently, they will follow the scheduled physical activities and adherence to the risk factor management according to individualised guidelines in their App, until the end of the study period. All data generated are recorded on the professional website. The degree of compliance with the objectives set is monitored by means of 7 coloured icons, which vary according to the target achievement.

Device: telemonitoring

control follow-up

OTHER

Patients in the control group will come to the ambulatory centre only once. The same educational talks as to the intervention group will be given. A conventional outpatient follow-up by primary care and the corresponding specialist will be carried out.

Other: control follow-up

Interventions

telemonitoring DEVICE

The system consists of the following elements: Professional website at the ambulatory centre, which allows: To set up an individualised care plan To establish the patient's risk profile and targets for improvement. Long-term monitoring of the evolution of cardiovascular risk factors and events that occurred Advise the patient on self-management strategies. Mobile application software with the following functions: Scheduled exercise sessions Medication reminder Measurement reminder (weight, blood pressure, heart rate, waist circumference, etc.) Messages: Inbox folder for system messages and messages generated by professionals for a specific patient or video conference. Training monitor: guides the patient in the performance of their exercise. Access to certified health information for patients

telemonitoring

control follow-up OTHER

Patients are instructed to perform 150 minutes per week of moderate physical activity and follow healthy lifestyles

control follow-up

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Patients after more than one year of an acute coronary syndrome of both sexes.
• Age equal to or less than 72 years.

You may not qualify if:

• Refusal of informed consent
• Advanced biological age.
• Kidney failure (GFR \< 30ml/min/1.73 m2).
• Liver failure (GOT \>2 times normal value).
• Ejection fraction less than 50%.
• Uncontrolled blood pressure (\>140/90 mmHg).
• Uncontrolled heart failure.
• Dissecting aortic aneurysm.
• Uncontrolled ventricular tachycardia or other dangerous ventricular arrhythmias.
• Aortic or mitral valve disease.
• Recent systemic or pulmonary embolism.
• Active or recent thrombophlebitis.
• Acute infectious diseases.
• Uncontrolled supraventricular arrhythmias or tachycardia.
• Repeated or frequent ventricular ectopic activity.

Sponsors & Collaborators

• Catcronic Salut SL: lead

Study Sites (1)

Hospital Arnau de Vilanova

Valencia, 46015, Spain

RECRUITING

Related Publications (4)

• Dalli-Peydro E, Gisbert-Criado R, Amigo N, Sanz-Sevilla N, Cosin-Sales J. Cardiac telerehabilitation with long-term follow-up reduces GlycA and improves lipoprotein particle profile: A randomised controlled trial. Int J Cardiol. 2022 Dec 15;369:60-64. doi: 10.1016/j.ijcard.2022.08.017. Epub 2022 Aug 6.

  PMID: 35944773 BACKGROUND

• Dalli Peydro E, Sanz Sevilla N, Tuzon Segarra MT, Miro Palau V, Sanchez Torrijos J, Cosin Sales J. A randomized controlled clinical trial of cardiac telerehabilitation with a prolonged mobile care monitoring strategy after an acute coronary syndrome. Clin Cardiol. 2022 Jan;45(1):31-41. doi: 10.1002/clc.23757. Epub 2021 Dec 24.

  PMID: 34952989 BACKGROUND

• Paoli G, Notarangelo MF, Mattioli M, La Sala R, Foa C, Solinas E, Fusco S, Fava C, Caminiti C, Artioli G, Pela G, Dall'Aglio E, Manari A, Tondi S, Rizzo A, Trapolin G, Patrizi G, Cappelli S, Villani GQ, Piepoli M, Zobbi G, Nicosia E, Ardissino D. ALLiance for sEcondary PREvention after an acute coronary syndrome. The ALLEPRE trial: A multicenter fully nurse-coordinated intensive intervention program. Am Heart J. 2018 Sep;203:12-16. doi: 10.1016/j.ahj.2018.06.001. Epub 2018 Jun 12.

  PMID: 29966801 BACKGROUND

• Buckley BJR, de Koning IA, Harrison SL, Fazio-Eynullayeva E, Underhill P, Kemps HMC, Lip GYH, Thijssen DHJ. Exercise-based cardiac rehabilitation vs. percutaneous coronary intervention for chronic coronary syndrome: impact on morbidity and mortality. Eur J Prev Cardiol. 2022 May 25;29(7):1074-1080. doi: 10.1093/eurjpc/zwab191.

  PMID: 34788451 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ernesto Dalli Peydró, MD

  Hospital Arnau de VIlanova. Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ernesto Dalli Peydró, MD

CONTACT

+34626388083; ernestodallip@gmail.com

Juan Cosín-Sales, MD

CONTACT

+34606338503; cosin_jua@gva.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The characteristics of the interventions do not allow the study to be blinded either for the patient or for the professional. However, the analyses and surveys will be performed in a masked manner without the assigned group being identified by the investigators who carry out the examinations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, open-label, prospective, parallel-group study

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: May 25, 2023
• Study Start: November 28, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)