Comparative Study Between Conventional and Telematic Patients Follow-up (TLM-CGD)

August 23, 2018 updated by: Manel Cremades, Germans Trias i Pujol Hospital

Comparative Study Between Conventional and Telematic Follow-up of Patient Treated in a General Ang GI Surgery Department (TLM-CGD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

The hypothesis is that a follow-up based on a telematic visit will no add extra comorbidities while could reduce costs and increase patients satisfaction.

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) Information regarding the type of follow-up and the instructions to perform the telematic visit will be provided to patients before discharge. The follow-up date will be set according to the established protocol for each type of pathology.

In case of clinical complications patients will be referred to the emergency department or will be visited in face-to-face basis.

The main and secondary outcomes will be evaluated 30 days after the date of the follow-up.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Face-to-face follow-up
Face-to-face follow-up after hospital discharge
Experimental: Telematic follow-up
Telematic follow-up after hospital discharge
Other: Telematic follow-up
Telematic follow-up by using a platform with videoconference

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow-up accomplishment
Time Frame: From date of discharge until the date of follow-up, 30 days after discharge
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergency department consultation
Time Frame: From discharge until 30 days after the follow-up date
Comparison between number of emergency department consultations in each group if related to the surgical procedure
From discharge until 30 days after the follow-up date
Patient satisfaction
Time Frame: 30 days after the follow-up date
Assessment of the patient satisfaction related to the follow-up using the NHS Outpatients Questionnaire. The results will be the comparision of percentage of each answer in each group.
30 days after the follow-up date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Germans Trias i Pujol Hospital

Investigators

  • Principal Investigator: Manel Cremades, MD, General and GI Surgical Department Staff

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2017

Primary Completion (Actual)

May 10, 2018

Study Completion (Actual)

August 23, 2018

Study Registration Dates

First Submitted

September 30, 2017

First Submitted That Met QC Criteria

October 6, 2017

First Posted (Actual)

October 9, 2017

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • GermansTIPH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

All the study will be carried out in our institution and no individual data will be shared with other researchers or investigation centers unless if needed to support our study results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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