Comparative Study Between Conventional and Telematic Patients Follow-up

NCT03304509 | Completed

• 1 other identifier: GermansTIPH
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a parallel group clinical trial comparing two types of follow-up in patients operated and treated in a General and GI surgery department. Face-to-face vs telematic follow-up by using a platform that offers videoconferencing will be compared. Patients will be included and assigned randomly to each group using an informatics program until 100 patients are reached in each arm of the study ("n" total = 200 patients) The main and secondary outcomes will be evaluated 30 days after the date of the follow-up.

Conditions

Telemedicine; General Surgery; Outpatients

Outcome Measures

Primary Outcomes (1)

• Follow-up accomplishment

  Percentage of patients that can finish the follow-up in the assigned group

  From date of discharge until the date of follow-up, 30 days after discharge

Secondary Outcomes (2)

• Emergency department consultation

  From discharge until 30 days after the follow-up date

• Patient satisfaction

  30 days after the follow-up date

Study Arms (2)

Face-to-face follow-up

NO INTERVENTION

Face-to-face follow-up after hospital discharge

Telematic follow-up

EXPERIMENTAL

Telematic follow-up after hospital discharge

Other: Telematic follow-up

Interventions

Telematic follow-up OTHER

Telematic follow-up by using a platform with videoconference

Telematic follow-up

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients treated or operated in the General and GI Surgery department in "Hospital Germans Trias i Pujol"

You may not qualify if:

• Proctological Surgery
• Personal conditions that not allow a correct comprehension or developement of the study
• Patients with postoperative complications greater than Clavien-Dindo grade II
• Not being in possession of the necessary informatic devices in case of telematic follow-up
• Not having a basic informatic knowledge in case of telematic follow-up

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Related Publications (19)

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  PMID: 26195452 BACKGROUND

• Rasmussen BS, Froekjaer J, Bjerregaard MR, Lauritsen J, Hangaard J, Henriksen CW, Halekoh U, Yderstraede KB. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers. Diabetes Care. 2015 Sep;38(9):1723-9. doi: 10.2337/dc15-0332. Epub 2015 Jun 26.

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  PMID: 12076550 BACKGROUND

Study Officials

• Manel Cremades, MD

  General and GI Surgical Department Staff

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Patients will be included and assigned randomly, using an informatic program, to one of the study arms before hospital discharge.

Study Record Dates

• First Submitted: September 30, 2017
• First Posted: October 9, 2017
• Study Start: March 19, 2017
• Primary Completion: May 10, 2018
• Study Completion: August 23, 2018
• Last Updated: August 24, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)