Assessing the safety of remote consultations in hospital follow-ups
Open Label Randomized Clinical Trial to Assess the Safety of Teleconsultation, Compared to the Traditional Clinical Consultation
This study tests if remote consultations, like phone or video calls, are safe for patients who need follow-up care at the hospital compared to in-person visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2136 (estimated) |
| Sex | All |
| Sponsor | Consorci Sanitari de l'Alt Penedès i Garraf Academic / other |
| Locations | 3 sites (Sant Pere de Ribes, Barcelona and 2 other locations) |
| Trial ID | NCT05094180 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety of remote consultations, including telephone and video calls, for patients in a secondary hospital setting. A total of 2136 patients will be randomly assigned to either face-to-face consultations or remote consultations. The primary focus is on monitoring the frequency of complications related to their underlying conditions and any adverse reactions to treatments. Eligible patients must have the necessary digital literacy and technology to participate in remote consultations.
Who should consider this trial
Good fit: Ideal candidates are patients who can engage in remote consultations and do not require physical examinations for their follow-up care.
Not a fit: Patients needing in-person evaluations or those with impairments affecting communication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and accessibility of follow-up care for patients with various clinical conditions.
How similar studies have performed: Other studies have shown promising results with remote consultations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sant Pere de Ribes, Barcelona and 2 other locations
- Hospital Residència Sant Camil — Sant Pere de Ribes, Barcelona, Spain (Recruiting)
- Hospital Comarcal de l'Alt Penedès — Vilafranca del Penedès, Barcelona, Spain (Recruiting)
- Centre de Rehabilitació — Vilanova i la Geltrú, Barcelona, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: Alejandro Rodríguez-Molinero, PhD
- Email: arodriguez@csapg.cat
- Phone: 938960025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.