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TelemedicineTLM-CGDNCT03304509

Comparative Study Between Conventional and Telematic Patients Follow-up

A study testing Telematic follow-up in people with Telemedicine and General Surgery, run by Germans Trias i Pujol Hospital at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Telemedicine, General Surgery, Outpatients
What is being tested?
Telematic follow-up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSpain
Study dates
19 Mar 2017to 23 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

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

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Telematic follow-up

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telematic follow-upOther

    Telematic follow-up by using a platform with videoconference

Study groups in NCT03304509
Study groupRoleWhat they receive
Face-to-face follow-upNo interventionFace-to-face follow-up after hospital discharge
Telematic follow-upExperimentalTelematic follow-up after hospital discharge
Receives: Other: Telematic follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Follow-up accomplishment

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

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

Secondary outcomes (2)

  1. Emergency department consultation

    Comparison between number of emergency department consultations in each group if related to the surgical procedure

    Measured: From discharge until 30 days after the follow-up date

  2. Patient satisfaction

    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.

    Measured: 30 days after the follow-up date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2017
  2. Study start19 Mar 2017
  3. Primary completion10 May 2018
  4. Study completion23 Aug 2018

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be included and assigned randomly, using an informatic program, to one of the study arms before hospital discharge.
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03304509
Sponsor's protocol ID
GermansTIPH
Acronym
TLM-CGD
Status last verified
Aug 2018
First submitted
30 Sep 2017
Last updated
24 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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

Publications

  • Johnston MJ, King D, Arora S, Behar N, Athanasiou T, Sevdalis N, Darzi A. Smartphones let surgeons know WhatsApp: an analysis of communication in emergency surgical teams. Am J Surg. 2015 Jan;209(1):45-51. doi: 10.1016/j.amjsurg.2014.08.030. Epub 2014 Oct 22.

    PubMed 25454952

  • Khanna V, Sambandam SN, Gul A, Mounasamy V. "WhatsApp"ening in orthopedic care: a concise report from a 300-bedded tertiary care teaching center. Eur J Orthop Surg Traumatol. 2015 Jul;25(5):821-6. doi: 10.1007/s00590-015-1600-y. Epub 2015 Jan 30.

    PubMed 25633127

  • Kvedar J, Coye MJ, Everett W. Connected health: a review of technologies and strategies to improve patient care with telemedicine and telehealth. Health Aff (Millwood). 2014 Feb;33(2):194-9. doi: 10.1377/hlthaff.2013.0992.

    PubMed 24493760

  • Armstrong KA, Coyte PC, Bhatia RS, Semple JL. The effect of mobile app home monitoring on number of in-person visits following ambulatory surgery: protocol for a randomized controlled trial. JMIR Res Protoc. 2015 Jun 3;4(2):e65. doi: 10.2196/resprot.4352.

    PubMed 26040252

  • Dobke MK, Bhavsar D, Gosman A, De Neve J, De Neve B. Pilot trial of telemedicine as a decision aid for patients with chronic wounds. Telemed J E Health. 2008 Apr;14(3):245-9. doi: 10.1089/tmj.2007.0038.

    PubMed 18570547

  • Weinstein RS, Lopez AM, Joseph BA, Erps KA, Holcomb M, Barker GP, Krupinski EA. Telemedicine, telehealth, and mobile health applications that work: opportunities and barriers. Am J Med. 2014 Mar;127(3):183-7. doi: 10.1016/j.amjmed.2013.09.032. Epub 2013 Oct 29.

    PubMed 24384059

  • Shah MN, Wasserman EB, Gillespie SM, Wood NE, Wang H, Noyes K, Nelson D, Dozier A, McConnochie KM. High-Intensity Telemedicine Decreases Emergency Department Use for Ambulatory Care Sensitive Conditions by Older Adult Senior Living Community Residents. J Am Med Dir Assoc. 2015 Dec;16(12):1077-81. doi: 10.1016/j.jamda.2015.07.009. Epub 2015 Aug 17.

    PubMed 26293419

  • Eisenberg D, Hwa K, Wren SM. Telephone follow-up by a midlevel provider after laparoscopic inguinal hernia repair instead of face-to-face clinic visit. JSLS. 2015 Jan-Mar;19(1):e2014.00205. doi: 10.4293/JSLS.2014.00205.

    PubMed 25848178

  • Charles BL. Telemedicine can lower costs and improve access. Healthc Financ Manage. 2000 Apr;54(4):66-9.

    PubMed 10915354

  • Pericas JM, Aibar J, Soler N, Lopez-Soto A, Sanclemente-Anso C, Bosch X. Should alternatives to conventional hospitalisation be promoted in an era of financial constraint? Eur J Clin Invest. 2013 Jun;43(6):602-15. doi: 10.1111/eci.12087. Epub 2013 Apr 17.

    PubMed 23590593

  • Bator EX, Gleason JM, Lorenzo AJ, Kanaroglou N, Farhat WA, Bagli DJ, Koyle MA. The burden of attending a pediatric surgical clinic and family preferences toward telemedicine. J Pediatr Surg. 2015 Oct;50(10):1776-82. doi: 10.1016/j.jpedsurg.2015.06.005. Epub 2015 Jun 20.

    PubMed 26195452

  • 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.

    PubMed 26116717

  • Sathiyakumar V, Apfeld JC, Obremskey WT, Thakore RV, Sethi MK. Prospective randomized controlled trial using telemedicine for follow-ups in an orthopedic trauma population: a pilot study. J Orthop Trauma. 2015 Mar;29(3):e139-45. doi: 10.1097/BOT.0000000000000189.

    PubMed 24983434

  • Sharareh B, Schwarzkopf R. Effectiveness of telemedical applications in postoperative follow-up after total joint arthroplasty. J Arthroplasty. 2014 May;29(5):918-922.e1. doi: 10.1016/j.arth.2013.09.019. Epub 2013 Dec 15.

    PubMed 24342278

  • Piqueras M, Marco E, Coll M, Escalada F, Ballester A, Cinca C, Belmonte R, Muniesa JM. Effectiveness of an interactive virtual telerehabilitation system in patients after total knee arthoplasty: a randomized controlled trial. J Rehabil Med. 2013 Apr;45(4):392-6. doi: 10.2340/16501977-1119.

    PubMed 23474735

Questions about this trial

What is this clinical trial studying?

A study testing Telematic follow-up in people with Telemedicine and General Surgery, run by Germans Trias i Pujol Hospital at 1 site 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 1 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: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Follow-up accomplishment (time frame: From date of discharge until the date of follow-up, 30 days after discharge). 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 NCT03304509, which also lists 19 linked publications.

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 24 Aug 2018.

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