Open Label Randomized Clinical Trial to Assess the Safety of Teleconsultation

  • STATUS
    Recruiting
  • End date
    Oct 30, 2023
  • participants needed
    6009
  • sponsor
    Consorci Sanitari de l'Alt Penedès i Garraf
Updated on 1 December 2021

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 6009 patients will be randomly allocated into one of the three study arms: A) face-to-face consultation (control) B) telephone consultation C) 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on a per-protocol study sample, which will include all participants who have finished the study and have not been withdrawn because of non-allowed visits using modalities other than scheduled.

Details
Condition Various Clinical Conditions Commonly Followed up in a Secondary Hospital
Treatment Teleconsultation, Video Consultation, Face-to-face appointment
Clinical Study IdentifierNCT05094180
SponsorConsorci Sanitari de l'Alt Penedès i Garraf
Last Modified on1 December 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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