NCT05094180: ECASeT

Open Label Randomized Clinical Trial to Assess the Safety of Teleconsultation

Recruiting now NA Last updated 25 June 2025

What this trial tests

NA trial testing Face-to-face appointment in Various Clinical Conditions Commonly Followed up in a Secondary Hospital in 2,136 participants. Currently enrolling.

Timeline

1 December 2021

Primary endpoint
31 July 2026

31 December 2026

Quick facts

Lead sponsor	Consorci Sanitari de l'Alt Penedès i Garraf
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	2,136
Start date	1 December 2021
Primary completion	31 July 2026
Estimated completion	31 December 2026
Sites	3 locations across Spain

Drugs / interventions tested

• Face-to-face appointment
• Remote consultation (telephone or video consultation mode)

Conditions studied

• Various Clinical Conditions Commonly Followed up in a Secondary Hospital — all drugs for Various Clinical Conditions Commonly Followed up in a Secondary Hospital →

Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf — full company profile →

Who can join

Eligibility, any sex, with Various Clinical Conditions Commonly Followed up in a Secondary Hospital. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Randomized-controlled trial to assess the safety of remote consultations (both video and teleconsultation) in the follow-up of patients in the hospital setting. A total of 2136 patients will be randomly allocated into one of the three study arms: A) face-to-face consultation (control) B) Remote consultation (telephone or video consultation). Primary outcome will be the frequency of complications of the underlying disease, including adverse reactions to the treatment of the underlying disease.

To be eligible for remote consultation, patients have to have adequate digital literacy at physician discretion, technological capacity to use the video conferencing software, and undergo a type of follow-up that, due to the moderate complexity of the pathology, do not require physical examinations. Patients followed up in more than three departments, those with visual or hearing impairments that may hamper patient-physician communication, and those enrolled in another clinical trial that requires an experimental intervention during the follow-up will be excluded from the study.

Physicians can schedule and cancel appointments at their discretion. At least three visits should be scheduled in the study setting: the baseline visit (i.e., screening visit), intermediate visits (pre-defined by the physician based on the follow-up needed for managing the baseline condition), and the final visit (i.e., either the follow-up visit closest to 12 ± 2 months after enrollment or before in case of discharge or early discontinuation).

The primary objective will be assessed using a non-inferiority analysis of the cumulative incidence of complications of the baseline disease between remote consultation (video and teleconsultation arms) and face-to-face consultation, using a non-inferiority margin of 2%. The analysis will be based on a modified binomial test to assess the non-inferiority of an experimental intervention vs. a control group in a three-arm trial. The primary analysis will be conducted on a per-protocol study sample, which will include all participants who have finished the study and have not been withdrawn because of non-allowed visits using modalities other than scheduled.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study.
   Rodríguez-Molinero A, Carot-Sans G, Escrig R, Tebé C, et al · · 2023 · cited 1× · PMID 38066614 · DOI 10.1186/s13063-023-07679-1
2. Study Protocol of a Randomized Controlled Trial to Assess Safety of Teleconsultation Compared with Face-to-Face Consultation. The ECASeT Study
   Rodríguez-Molinero A, Carot-Sans G, Escrig R, Tebé C, et al · · 2023 · DOI 10.21203/rs.3.rs-3116350/v1