Telemedicine in Atrial Fibrillation: Randomized Clinical Trial in Primary Care (AtrialConnect)

NCT05893199 | Unknown

• 1 other identifier: AtrialConnect
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the world, with a large consumption of health resources. Telemedicine represents a new model of care, facilitating the individual approach to each patient and reducing costs and complications. This is an an open-label, randomized, multicenter, clinical trial aiming to analyze the use of telemedicine with AF patients in real clinical practice at primary care in terms of efficacy, efficiency, patient perception and professional satisfaction. The intervention will be based on the use of the Ti.Care app as the telemedicine support, in addition to the usual care. The follow-up will be carried out for 12 months.

Conditions

Atrial Fibrillation

Keywords

Telemedicine; Atrial Fibrillation; Primary care; Patient perception; Quality of life; Efficacy; Efficiency; Job Satisfaction; Patient safety; Mobile Applications

Outcome Measures

Primary Outcomes (11)

• Blood pressure control

  Measured with systolic and diastolic blood pressure

  one year

• Incidence of ischemic stroke

  Measured as the number of recorded ischaemic stroke events in the study months.

  one year

• Incidence of bleeding

  Number of bleeding events of any type recorded during follow-up.

  one year

• Number of emergency visits

  Number of recorded visits to the emergency department in the study months.

  one year

• Number of hospitalizations

  Number of hospital admissions for AF decompensation and its associated diseases during the study period.

  one year

• Number of visits to primary care

  Number of registered visits to the primary care service in the study months.

  one year

• Costs of care

  The indexes and prices of the Consejería de Sanidad for each type of consultation or hospitalisation and the established retail prices in the year of the study for medicines will be used.

  one year

• Health-Related Quality Of Life

  Measured with EuroQol 5D questionnaire

  one year

• Therapeutic adherence

  Measured with MMAS-8 Test (High adherence (8 or \> 8 points), medium (6 or 7 points) and low adherence (5 or \<5 points))

  one year

• Patient satisfaction with the mobile application

  Measured by the survey on satisfaction and perception of the use of new technologies in the field (designed for the study). Scoring: High satisfaction (4 or 5 points), medium (3 points), low satisfaction (1 or 2 points).

  one year

• Professionals' satisfaction with the mobile application

  Measured by the survey on satisfaction and perception of the use of new technologies in the field (designed for the study). Scoring: High satisfaction (5-7 points), medium (3 or 4 points), low satisfaction (1 or 2 points).

  one year

Study Arms (2)

Telemedicine

EXPERIMENTAL

Patients in the intervention group (Telemedicine) will be followed up using the Ti.Care App in addition to the usual primary care follow-up.

Device: Clinical monitoring using the Ti.Care app (https://ti.care/es); Other: Usual care

Primary care

ACTIVE COMPARATOR

Patients in the control group will be followed up exclusively in primary care.

Other: Usual care

Interventions

Clinical monitoring using the Ti.Care app (https://ti.care/es) DEVICE

Clinical monitoring using the Ti.Care app (https://ti.care/es)

Telemedicine

Usual care OTHER

usual follow-up in primary care both arms

Primary care; Telemedicine

Eligibility Criteria

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

You may qualify if:

• Patients over 18 years of age diagnosed with AF.
• Without difficulties in using the mobile App or patients with difficulties in using the mobile App but with good family or caregiver support, who understand its use.

You may not qualify if:

• Terminally ill patient.
• Refusal to participate on the part of the patient
• Difficulties in understanding the contents of the mobile App (cognitive impairment, dependence for activities of daily living, etc.) and no enabling family support

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Related Publications (9)

• Bodenheimer T, Sinsky C. From triple to quadruple aim: care of the patient requires care of the provider. Ann Fam Med. 2014 Nov-Dec;12(6):573-6. doi: 10.1370/afm.1713.

  PMID: 25384822 BACKGROUND

• Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.

  PMID: 30700139 RESULT

• Orozco-Beltran D, Brotons Cuixart C, Aleman Sanchez JJ, Banegas Banegas JR, Cebrian-Cuenca AM, Gil Guillen VF, Martin Rioboo E, Navarro Perez J. [Cardiovascular preventive recommendations. PAPPS 2020 update]. Aten Primaria. 2020 Nov;52 Suppl 2(Suppl 2):5-31. doi: 10.1016/j.aprim.2020.08.002. Spanish.

  PMID: 33388118 RESULT

• Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.

  PMID: 34458905 RESULT

• MacKinnon GE, Brittain EL. Mobile Health Technologies in Cardiopulmonary Disease. Chest. 2020 Mar;157(3):654-664. doi: 10.1016/j.chest.2019.10.015. Epub 2019 Oct 31.

  PMID: 31678305 RESULT

• Orozco-Beltran D, Sanchez-Molla M, Sanchez JJ, Mira JJ; ValCronic Research Group. Telemedicine in Primary Care for Patients With Chronic Conditions: The ValCronic Quasi-Experimental Study. J Med Internet Res. 2017 Dec 15;19(12):e400. doi: 10.2196/jmir.7677.

  PMID: 29246881 RESULT

• Pezel T, Berthelot E, Gauthier J, Chong-Nguyen C, Iliou MC, Juilliere Y, Galinier MC, De Groote P, Beauvais F, Bauer F, Vergeylen U, Gellen B, Raphael P, Bezard M, Ricci JE, Boiteux MC, Bonnefous L, Bodez D, Audureau E, Damy T. Epidemiological characteristics and therapeutic management of patients with chronic heart failure who use smartphones: Potential impact of a dedicated smartphone application (report from the OFICSel study). Arch Cardiovasc Dis. 2021 Jan;114(1):51-58. doi: 10.1016/j.acvd.2020.05.006. Epub 2020 Aug 28.

  PMID: 32868257 RESULT

• Herdman M, Badia X, Berra S. [EuroQol-5D: a simple alternative for measuring health-related quality of life in primary care]. Aten Primaria. 2001 Oct 15;28(6):425-30. doi: 10.1016/s0212-6567(01)70406-4. No abstract available. Spanish.

  PMID: 11602124 RESULT

• Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

  PMID: 32860505 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ariana Jordá Baldó, Medicine

  Physician at Virgen del Puerto Hospital

  PRINCIPAL INVESTIGATOR

• Domingo L Orozco Beltrán, Medicine

  Professor at Miguel Hernández University

  STUDY DIRECTOR

Central Study Contacts

Ariana Jordá Baldó, Medicine

CONTACT

696857890; ariana_jorda@hotmail.com

Domingo Orozco Beltrán, Medicine

CONTACT

dorozco@umh.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 7, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: June 7, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share