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

Atrial Fibrillation Clinical Trial

Official title:

Telemedicine in Atrial Fibrillation: Randomized Clinical Trial in Primary Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05893199
• Other study ID #: AtrialConnect
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2023
• Source: Universidad Miguel Hernandez de Elche
• Contact: Ariana Jordá Baldó, Medicine
• Phone: 696857890
• Email: ariana_jorda[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia in the world, with a prevalence between 2-4%. Given the increase in prevalence, its associated morbidity and mortality, and the large consumption of health resources there has been a need to adapt health care models. Telemedicine and the use of mobile devices represent a new model of care for chronic patients, facilitating the individual approach to each patient and reducing the disability associated with their chronic pathology.

Objective: To analyze the use of telemedicine in patients with atrial fibrillation in real clinical practice in primary care trying in terms of efficacy (blood pressure control, incidence of ischemic stroke, incidence of bleeding), efficiency (number of visits to the clinic, hospitalizations, costs of care), patient perception (quality of life, therapeutic adherence, satisfaction with the mobile App) and professional satisfaction (satisfaction with the mobile App and benefits of its use in the clinic).

Methods: The investigators propose to conduct an open-label, randomized, multicenter clinical trial. The intervention will be based on the use of the Ti.Care app as the telemedicine support, in addition to the usual care with their primary care physician (PCP). The control group will perform the usual follow-up with their PCP. The follow-up will be carried out for 12 months, and is proposed as an effective and cost-efficient improvement for the national health system and for the patient.

Key words: Telemedicine, Mobile Applications, Atrial Fibrillation, Primary Health Care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Other:
• Usual care
usual follow-up in primary care both arms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche

References & Publications (9)

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, Lic — View Citation

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. — View Citation

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. — View Citation

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 I — View Citation

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. — View Citation

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- — View Citation

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.767 — View Citation

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 characteris — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure control	Measured with systolic and diastolic blood pressure	one year
Primary	Incidence of ischemic stroke	Measured as the number of recorded ischaemic stroke events in the study months.	one year
Primary	Incidence of bleeding	Number of bleeding events of any type recorded during follow-up.	one year
Primary	Number of emergency visits	Number of recorded visits to the emergency department in the study months.	one year
Primary	Number of hospitalizations	Number of hospital admissions for AF decompensation and its associated diseases during the study period.	one year
Primary	Number of visits to primary care	Number of registered visits to the primary care service in the study months.	one year
Primary	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
Primary	Health-Related Quality Of Life	Measured with EuroQol 5D questionnaire	one year
Primary	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
Primary	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
Primary	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