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

Primary Purpose

Chronic Coronary Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
telemonitoring
control follow-up
Sponsored by
Catcronic Salut SL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Coronary Syndrome focused on measuring mobile health, Chronic coronary syndrome, cardiac rehabilitation, telerehabilitation, secondary prevention, exercise

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. Moderate pulmonary hypertension. Ventricular aneurysm. Uncontrolled diabetes, thyrotoxicosis, myxedema, Conduction disorders such as: complete atrioventricular block. Left bundle branch block. Wolf-Parkinson-White syndrome. Fixed rate pacing. Severe anaemia. Psychoneurotic disorders. Neuromuscular, musculoskeletal and arthritic disorders that may limit activity. may limit activity.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    telemonitoring

    control follow-up

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    The 6-min walk distance (6MWD)
    Meters (m)

    Secondary Outcome Measures

    Maximal heart rate in the six minute walk test
    beats per minute (bpm)
    Total cholesterol
    mg/dL
    Glycosylated haemoglobin
    Percentage (%)
    Weight
    Kilograms (Kg)
    Waist circumference
    waist circumference change (cm)
    Visceral fat
    percentage (%)
    Energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire
    Kcal/week
    High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire
    percentage
    Total score of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED).
    Units. Minimum value: 0, maximum value: 14. Higher scores mean a better outcome.
    Global score of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
    Units. Minimum value: 0, maximum value: 14. Lower scores mean a better outcome.
    Anxiety subscale of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
    Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome.
    Depression subscale of Emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
    Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome.
    Global index of the health-related quality of life obtained from the European Quality of Life questionnaire (EuroQol-5D)
    Units. Minimum value: 0, maximum value: 1. Higher scores mean a better outcome.
    Health status obtained from the European Quality of Life questionnaire (EuroQol-5D)
    Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.
    smoking cessation
    percentage
    User's experience from the System Usability Scale (SUS) score
    Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.
    Cost-effectiveness analysis
    net cost divided by changes in health outcomes
    Body mass Index
    weight and height will be combined to report BMI (kg/m^2)
    High
    centimeters (cm)
    Percentage expected for age and sex in the six minute walk test
    Percentage
    Leukocyte count
    WBCs per microliter
    Neutrophil count
    Neutrophils per microliter and percentage of white blood cells
    Lymphocyte count
    Lymphocytes per microliter and percentage of white blood cells
    Platelet count
    Platelets per microliter
    GlycA
    μmol/L
    Small LDL particles
    μmol/L
    Physical activity derived from the International Physical Activity questionnaire (IPAQ)
    self-reported physical activity measured in metabolic equivalents (MET-min/week) Minimum value: 0, maximum value 19,278. Higher scores mean a better outcome.
    HDL cholesterol
    mg/dL
    LDL cholesterol
    mg/dL
    Non-HDL cholesterol
    mg/dL
    Triglycerides
    mg/dL
    Apolipoprotein B/Apolipoprotein A-I ratio
    Units

    Full Information

    First Posted
    March 18, 2023
    Last Updated
    May 23, 2023
    Sponsor
    Catcronic Salut SL
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05875311
    Brief Title
    Telemonitoring System for Improving Continuity of Care in Patients With Chronic Coronary Syndrome (TELSINCORC)
    Acronym
    TELSINCORC
    Official Title
    Usefulness of a Telemonitoring System to Optimize Continuity of Care From Cardiology to Primary Care in Patients With Chronic Coronary Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    October 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Catcronic Salut SL

    4. Oversight

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

    5. Study Description

    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.
    Detailed Description
    The patients who have suffered an acute coronary event have a recurrence rate of 2.5% to 15.5% person-years during the first year. Control of cardiovascular risk factors can improve the prognosis of these patients. Following the results of a clinical trial to validate a comprehensive monitoring system called Cardioplan, with a prolonged monitoring strategy, The investigators aim to conduct a study in patients with chronic coronary syndrome in the primary care setting comparing a control group with standard follow-up and a 10-month telemonitored group. Four primary care centres will participate. Two health centres attend mainly a population with a medium-high upper socioeconomic level and the other two mainly a population with a medium-low socioeconomic level. A total of 160 subjects are expected to be included in the follow-up, with 80 subjects in each study group. The primary endpoint is to demonstrate that telemonitored follow-up improves functional exercise capacity compared to usual care, by assessing the distance in meters covered in the 6-minute walk test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Coronary Syndrome
    Keywords
    mobile health, Chronic coronary syndrome, cardiac rehabilitation, telerehabilitation, secondary prevention, exercise

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Pragmatic, open-label, prospective, parallel-group study
    Masking
    Outcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    telemonitoring
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control follow-up
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    telemonitoring
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    control follow-up
    Intervention Description
    Patients are instructed to perform 150 minutes per week of moderate physical activity and follow healthy lifestyles
    Primary Outcome Measure Information:
    Title
    The 6-min walk distance (6MWD)
    Description
    Meters (m)
    Time Frame
    10 months
    Secondary Outcome Measure Information:
    Title
    Maximal heart rate in the six minute walk test
    Description
    beats per minute (bpm)
    Time Frame
    10 months
    Title
    Total cholesterol
    Description
    mg/dL
    Time Frame
    10 months
    Title
    Glycosylated haemoglobin
    Description
    Percentage (%)
    Time Frame
    10 months
    Title
    Weight
    Description
    Kilograms (Kg)
    Time Frame
    10 months
    Title
    Waist circumference
    Description
    waist circumference change (cm)
    Time Frame
    10 months
    Title
    Visceral fat
    Description
    percentage (%)
    Time Frame
    10 months
    Title
    Energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire
    Description
    Kcal/week
    Time Frame
    10 months
    Title
    High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire
    Description
    percentage
    Time Frame
    10 months
    Title
    Total score of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED).
    Description
    Units. Minimum value: 0, maximum value: 14. Higher scores mean a better outcome.
    Time Frame
    10 months
    Title
    Global score of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
    Description
    Units. Minimum value: 0, maximum value: 14. Lower scores mean a better outcome.
    Time Frame
    10 months
    Title
    Anxiety subscale of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
    Description
    Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome.
    Time Frame
    10 months
    Title
    Depression subscale of Emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
    Description
    Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome.
    Time Frame
    10 months
    Title
    Global index of the health-related quality of life obtained from the European Quality of Life questionnaire (EuroQol-5D)
    Description
    Units. Minimum value: 0, maximum value: 1. Higher scores mean a better outcome.
    Time Frame
    10 months
    Title
    Health status obtained from the European Quality of Life questionnaire (EuroQol-5D)
    Description
    Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.
    Time Frame
    10 months
    Title
    smoking cessation
    Description
    percentage
    Time Frame
    10 months
    Title
    User's experience from the System Usability Scale (SUS) score
    Description
    Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.
    Time Frame
    10 months
    Title
    Cost-effectiveness analysis
    Description
    net cost divided by changes in health outcomes
    Time Frame
    10 months
    Title
    Body mass Index
    Description
    weight and height will be combined to report BMI (kg/m^2)
    Time Frame
    10 months
    Title
    High
    Description
    centimeters (cm)
    Time Frame
    10 months
    Title
    Percentage expected for age and sex in the six minute walk test
    Description
    Percentage
    Time Frame
    10 months
    Title
    Leukocyte count
    Description
    WBCs per microliter
    Time Frame
    10 month
    Title
    Neutrophil count
    Description
    Neutrophils per microliter and percentage of white blood cells
    Time Frame
    10 monts
    Title
    Lymphocyte count
    Description
    Lymphocytes per microliter and percentage of white blood cells
    Time Frame
    10 month
    Title
    Platelet count
    Description
    Platelets per microliter
    Time Frame
    10 month
    Title
    GlycA
    Description
    μmol/L
    Time Frame
    10 monts
    Title
    Small LDL particles
    Description
    μmol/L
    Time Frame
    10 months
    Title
    Physical activity derived from the International Physical Activity questionnaire (IPAQ)
    Description
    self-reported physical activity measured in metabolic equivalents (MET-min/week) Minimum value: 0, maximum value 19,278. Higher scores mean a better outcome.
    Time Frame
    10 months
    Title
    HDL cholesterol
    Description
    mg/dL
    Time Frame
    10 months
    Title
    LDL cholesterol
    Description
    mg/dL
    Time Frame
    10 months
    Title
    Non-HDL cholesterol
    Description
    mg/dL
    Time Frame
    10 months
    Title
    Triglycerides
    Description
    mg/dL
    Time Frame
    10 months
    Title
    Apolipoprotein B/Apolipoprotein A-I ratio
    Description
    Units
    Time Frame
    10 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    72 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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. Moderate pulmonary hypertension. Ventricular aneurysm. Uncontrolled diabetes, thyrotoxicosis, myxedema, Conduction disorders such as: complete atrioventricular block. Left bundle branch block. Wolf-Parkinson-White syndrome. Fixed rate pacing. Severe anaemia. Psychoneurotic disorders. Neuromuscular, musculoskeletal and arthritic disorders that may limit activity. may limit activity.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ernesto Dalli Peydró, MD
    Phone
    +34626388083
    Email
    ernestodallip@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ernesto Dalli Peydró, MD
    Organizational Affiliation
    Hospital Arnau de VIlanova. Valencia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35944773
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34952989
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29966801
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34788451
    Citation
    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.
    Results Reference
    background

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

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