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

May 30, 2023 updated by: Domingo Orozco Beltrán, Universidad Miguel Hernandez de Elche

Telemedicine in Atrial Fibrillation: Randomized Clinical Trial in Primary Care

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telemedicine
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)
Clinical monitoring using the Ti.Care app (https://ti.care/es)
Other: Usual care
usual follow-up in primary care both arms
Active Comparator: Primary care
Patients in the control group will be followed up exclusively in primary care.
Other: Usual care
usual follow-up in primary care both arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure control
Time Frame: one year
Measured with systolic and diastolic blood pressure
one year
Incidence of ischemic stroke
Time Frame: one year
Measured as the number of recorded ischaemic stroke events in the study months.
one year
Incidence of bleeding
Time Frame: one year
Number of bleeding events of any type recorded during follow-up.
one year
Number of emergency visits
Time Frame: one year
Number of recorded visits to the emergency department in the study months.
one year
Number of hospitalizations
Time Frame: one year
Number of hospital admissions for AF decompensation and its associated diseases during the study period.
one year
Number of visits to primary care
Time Frame: one year
Number of registered visits to the primary care service in the study months.
one year
Costs of care
Time Frame: one year
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
Time Frame: one year
Measured with EuroQol 5D questionnaire
one year
Therapeutic adherence
Time Frame: one year
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
Time Frame: one year
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
Time Frame: one year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Miguel Hernandez de Elche

Investigators

  • Principal Investigator: Ariana Jordá Baldó, Medicine, Physician at Virgen del Puerto Hospital
  • Study Director: Domingo L Orozco Beltrán, Medicine, Professor at Miguel Hernández University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AtrialConnect

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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