Open Label Randomized Clinical Trial to Assess the Safety of Teleconsultation

NCT ID: NCT05094180

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2026-12-31

Brief Summary

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on a per-protocol study sample, which will include all participants who have finished the study and have not been withdrawn because of non-allowed visits using modalities other than scheduled.

Conditions

Various Clinical Conditions Commonly Followed up in a Secondary Hospital

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Face-to-face consultation

Group Type: OTHER

Face-to-face appointment

Intervention Type: OTHER

Participants will be scheduled with face-to-face appointments as usual (control arm). All phone calls (except reminders for scheduled visits) performed by the physician during the study will be recorded. Per protocol, participants allocated in the control arm can receive up to 25% of physician-doctor interactions by phone (that is, one phone call allowed for three face-to-face appointments).

Remote consultation (telephone or video consultation mode)

Group Type: ACTIVE_COMPARATOR

Remote consultation (telephone or video consultation mode)

Intervention Type: OTHER

Patients will be seen through one of the two remote consultation modalities: video consultation or telephone. Patients will receive a reminder by text or call before the appointment.

In the case of telephone consultation, patients will be informed of the date and time slot in which they must wait for the doctor's call. At the time of the appointment, the doctor will call the contact phone number of the patients and/or their family members, starting with the first contact number that appears in the patient's medical history, and using the rest of the contacts available if there is no response. .

In the case of video consultation, at the time of the appointment, patients will receive a link to the application that manages the teleconsultation. Once in the application, they will remain in the virtual waiting room until the doctor switches to the videoconference.

Interventions

Face-to-face appointment

Participants will be scheduled with face-to-face appointments as usual (control arm). All phone calls (except reminders for scheduled visits) performed by the physician during the study will be recorded. Per protocol, participants allocated in the control arm can receive up to 25% of physician-doctor interactions by phone (that is, one phone call allowed for three face-to-face appointments).

Intervention Type: OTHER

Remote consultation (telephone or video consultation mode)

Patients will be seen through one of the two remote consultation modalities: video consultation or telephone. Patients will receive a reminder by text or call before the appointment.

In the case of telephone consultation, patients will be informed of the date and time slot in which they must wait for the doctor's call. At the time of the appointment, the doctor will call the contact phone number of the patients and/or their family members, starting with the first contact number that appears in the patient's medical history, and using the rest of the contacts available if there is no response. .

In the case of video consultation, at the time of the appointment, patients will receive a link to the application that manages the teleconsultation. Once in the application, they will remain in the virtual waiting room until the doctor switches to the videoconference.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and women of any age.
• Possibility of making consultations by telephone, at the discretion of the investigator, taking into account the severity and complexity of the baseline pathology and the objective of health care.
• Forecast to carry out follow-up in external consultation.
• Agreement to be attended through a non-face-to-face system.
• Ability to connect to the video consultation system.
• Device compatible with the video consultation system.
• Possibility of collaborating in the necessary evaluations.
• Legal capacity to give informed consent.
• Signature of the informed consent for inclusion of the study.

Exclusion Criteria

• Need to carry out physical examinations, visualize the patient in person or perform techniques that involve face-to-face visits.
• Need for face-to-face consultation due patient's clinical situation.
• Follow-up by more than three medical specialists.
• Visual, hearing or functional impairments that may hamper patient-physician communication.
• Patients enrolled in another clinical trial that requires an experimental intervention during the follow-up.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Català de la Salut

OTHER

Sponsor Role: collaborator

Consorci Sanitari de l'Alt Penedès i Garraf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Residència Sant Camil

Sant Pere de Ribes, Barcelona, Spain

Site Status: RECRUITING

Hospital Comarcal de l'Alt Penedès

Vilafranca del Penedès, Barcelona, Spain

Site Status: RECRUITING

Centre de Rehabilitació

Vilanova i la Geltrú, Barcelona, Spain

Site Status: NOT_YET_RECRUITING

Countries

Spain

Central Contacts

Alejandro Rodríguez-Molinero, PhD

Role: CONTACT

arodriguez@csapg.cat

938960025 ext. 47158

Facility Contacts

Alejandro Rodríguez-Molinero

Role: primary

Alejandro Rodríguez-Molinero

Role: primary

References

Rodriguez-Molinero A, Carot-Sans G, Escrig R, Tebe C, Arce J, Perez-Lopez C, Ballesta S, Verdejo G, Cedeno A, Riera-Pagespetit M, Vivas-Angeles S, Alarcon JL, Navarro I, Toro S, Mateo L, Torres AJ, Delmas G, Camell H, Chamero A, Gasol M, Piera-Jimenez J; ECASeT Research Group. Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study. Trials. 2023 Dec 8;24(1):797. doi: 10.1186/s13063-023-07679-1.

Reference Type: DERIVED

PMID: 38066614 (View on PubMed)

Other Identifiers

CSAPG-15

Identifier Type: -

Identifier Source: org_study_id