Various Clinical Conditions Commonly Followed up in a Secondary HospitalECASeTNCT05094180
Open Label Randomized Clinical Trial to Assess the Safety of Teleconsultation
A study testing Face-to-face appointment and Remote consultation (telephone or video consultation mode) in people with Various Clinical Conditions Commonly Followed up in a Secondary Hospital, run by Consorci Sanitari de l'Alt Penedès i Garraf at 3 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Various Clinical Conditions Commonly Followed up in a Secondary Hospital
- What is being tested?
- Face-to-face appointment and Remote consultation (telephone or video consultation mode)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,136 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Dec 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- Possibility of collaborating in the necessary evaluations.
- Legal capacity to give informed consent.
- Signature of the informed consent for inclusion of the study.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Residència Sant Camil
Sant Pere de Ribes, Barcelona, 08810
Alejandro Rodríguez-Molinero
- Recruiting
Hospital Comarcal de l'Alt Penedès
Vilafranca del Penedès, Barcelona, 08720
- Not yet recruiting
Centre de Rehabilitació
Vilanova i la Geltrú, Barcelona, 08800
Alejandro Rodríguez-Molinero
About this study
Official title: Open Label Randomized Clinical Trial to Assess the Safety of Teleconsultation, Compared to the Traditional Clinical Consultation
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.
Read more
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.
- Being tested
- Face-to-face appointment, Remote consultation (telephone or video consultation mode)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face appointmentOther
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)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.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face consultation | Other | Not described Receives: Other: Face-to-face appointment |
| Remote consultation (telephone or video consultation mode) | Active comparator | Not described Receives: Other: Remote consultation (telephone or video consultation mode) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications of the underlying disease
Frequency of complications of the underlying disease, including adverse reactions to the treatment of the underlying disease
Measured: 12 months
Secondary outcomes (8)
Severe complications of the baseline disease
Frequency of severe complications of the underlying disease.
Measured: 12 months
Treatment Serious Adverse Event
Frequency of Serious Adverse Events related to the underlying disease's treatment
Measured: 12 months
Avoidable hospitalizations
Total and avoidable hospitalizations, secondary to ambulatory care sensitive conditions
Measured: 12 months
Number of unscheduled medical contacts
Count of unscheduled medical contacts (phone calls, unscheduled visits, ER visits, and admissions) registered in the hospital information system
Measured: 12 months
Care process indicators
Number of consultations made in a format different from the one initially foreseen (face-to-face, telephone consultation or video consultation) Number of empty consultations (the patient does not attend) Number of patients who interrupt their outpatient follow-up Number of prescriptions and type of prescription
Measured: 12 months
Healthcare expenditure
Estimated healthcare expenditure associated with each of the three interventions
Measured: 12 months
Usability of video consultation system
Usability of video consultation system, measured by using the Computer System Usability Questionnaire
Measured: 12 months
Satisfaction of users (health professionals and patients) with the process of clinical care
Degree of satisfaction of users (health professionals and patients) with the process of clinical care, measured by using the satisfaction questionary of the Pla d'enquestes de satisfacció del CatSalut
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Dec 2021
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Various Clinical Conditions Commonly Followed up in a Secondary HospitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català de la Salut
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094180
- Sponsor's protocol ID
- CSAPG-15
- Acronym
- ECASeT
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2021
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38066614
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Randomized Clinical Trial to Assess the Safety of Teleconsultation, Compared to the Traditional Clinical Consultation
- ClinicalTrials.gov ID
- NCT05094180
- Acronym / sponsor ID
- ECASeT / CSAPG-15
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,136 participants (estimated)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Collaborators
- Institut Català de la Salut
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-to-face consultation | Other | Other: Face-to-face appointment |
| Remote consultation (telephone or video consultation mode) | Active comparator | Other: Remote consultation (telephone or video consultation mode) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-to-face appointmentParticipants 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). | Other | Face-to-face consultation |
| 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. | Other | Remote consultation (telephone or video consultation mode) |
Primary outcome
Complications of the underlying disease
Time frame: 12 months
Frequency of complications of the underlying disease, including adverse reactions to the treatment of the underlying disease
8 secondary outcomes
Severe complications of the baseline disease
Time frame: 12 months
Treatment Serious Adverse Event
Time frame: 12 months
Avoidable hospitalizations
Time frame: 12 months
Number of unscheduled medical contacts
Time frame: 12 months
Care process indicators
Time frame: 12 months
Healthcare expenditure
Time frame: 12 months
Usability of video consultation system
Time frame: 12 months
Satisfaction of users (health professionals and patients) with the process of clinical care
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Derived from this study: PubMed 38066614Rodriguez-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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face appointment and Remote consultation (telephone or video consultation mode) in people with Various Clinical Conditions Commonly Followed up in a Secondary Hospital, run by Consorci Sanitari de l'Alt Penedès i Garraf at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Rodríguez-Molinero, PhD (938960025 ext. 47158, arodriguez@csapg.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications of the underlying disease (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05094180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.