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Chronic Coronary SyndromeTELSINCORCNCT05875311

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

A study testing telemonitoring in people with Chronic Coronary Syndrome, run by Catcronic Salut SL at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 72 years
Conditions the study is for
Chronic Coronary Syndrome
What is being tested?
telemonitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteSpain
Study dates
28 Nov 2023to 1 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 72 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 24Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Ernesto Dalli Peydró, MD contact

+34626388083

ernestodallip@gmail.com

Juan Cosín-Sales, MD contact

+34606338503

cosin_jua@gva.es

Spain1 site, 1 recruiting

  • Hospital Arnau de Vilanova

    Valencia, 46015

    Ernesto Dalli Peydro, MD, +34626388083, ernestodallip@gmail.com

    Juan Cosín Sales, MD, +34 606338044, cosin_jua@gva.es

    Recruiting

Other trials in Spain

About this study

Official title: Usefulness of a Telemonitoring System to Optimize Continuity of Care From Cardiology to Primary Care in Patients With Chronic Coronary Syndrome

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.

Read the 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.

Being tested
telemonitoring, control follow-up
Keywords
mobile health, Chronic coronary syndrome, cardiac rehabilitation, telerehabilitation, secondary prevention, exercise
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • telemonitoringDevice

    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

  • control follow-upOther

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

Study groups in NCT05875311
Study groupRoleWhat they receive
telemonitoringExperimentalPatients 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.
Receives: Device: telemonitoring
control follow-upOtherPatients 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.
Receives: Other: control follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The 6-min walk distance (6MWD)

    Meters (m)

    Measured: 10 months

Secondary outcomes (32)

  1. Maximal heart rate in the six minute walk test

    beats per minute (bpm)

    Measured: 10 months

  2. Total cholesterol

    mg/dL

    Measured: 10 months

  3. Glycosylated haemoglobin

    Percentage (%)

    Measured: 10 months

  4. Weight

    Kilograms (Kg)

    Measured: 10 months

  5. Waist circumference

    waist circumference change (cm)

    Measured: 10 months

  6. Visceral fat

    percentage (%)

    Measured: 10 months

  7. Energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire

    Kcal/week

    Measured: 10 months

  8. High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire

    percentage

    Measured: 10 months

  9. 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.

    Measured: 10 months

  10. 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.

    Measured: 10 months

  11. 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.

    Measured: 10 months

  12. 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.

    Measured: 10 months

  13. 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.

    Measured: 10 months

  14. 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.

    Measured: 10 months

  15. smoking cessation

    percentage

    Measured: 10 months

  16. User's experience from the System Usability Scale (SUS) score

    Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.

    Measured: 10 months

  17. Cost-effectiveness analysis

    net cost divided by changes in health outcomes

    Measured: 10 months

  18. Body mass Index

    weight and height will be combined to report BMI (kg/m^2)

    Measured: 10 months

  19. High

    centimeters (cm)

    Measured: 10 months

  20. Percentage expected for age and sex in the six minute walk test

    Percentage

    Measured: 10 months

  21. Leukocyte count

    WBCs per microliter

    Measured: 10 month

  22. Neutrophil count

    Neutrophils per microliter and percentage of white blood cells

    Measured: 10 monts

  23. Lymphocyte count

    Lymphocytes per microliter and percentage of white blood cells

    Measured: 10 month

  24. Platelet count

    Platelets per microliter

    Measured: 10 month

  25. GlycA

    μmol/L

    Measured: 10 monts

  26. Small LDL particles

    μmol/L

    Measured: 10 months

  27. 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.

    Measured: 10 months

  28. HDL cholesterol

    mg/dL

    Measured: 10 months

  29. LDL cholesterol

    mg/dL

    Measured: 10 months

  30. Non-HDL cholesterol

    mg/dL

    Measured: 10 months

  31. Triglycerides

    mg/dL

    Measured: 10 months

  32. Apolipoprotein B/Apolipoprotein A-I ratio

    Units

    Measured: 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2023
  2. Study start28 Nov 2023
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion1 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pragmatic, open-label, prospective, parallel-group study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05875311
Sponsor's protocol ID
TRISA-2023
Acronym
TELSINCORC
Status last verified
Jun 2024
First submitted
18 Mar 2023
Last updated
4 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35944773

  • 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.

    PubMed 34952989

  • 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.

    PubMed 29966801

  • 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.

    PubMed 34788451

Questions about this trial

What is this clinical trial studying?

A study testing telemonitoring in people with Chronic Coronary Syndrome, run by Catcronic Salut SL at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ernesto Dalli Peydró, MD (+34626388083, ernestodallip@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The 6-min walk distance (6MWD) (time frame: 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05875311, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.

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