CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 110 enrolled
Drug / intervention
Videoconference stoma careother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01600508
NCT01600508N/ACompleted

. A Randomized Controlled Trial Comparing Videoconference and Outpatient Stoma Care

University Hospital of North Norway·interventional·Posted May 17, 2012·Updated Jun 17, 2016

In Brief

A clinical study evaluating Videoconference stoma care for Surgical Operation With Formation of External Stoma. Completed, enrolled 110 participants.

Detailed Summary

Background: Videoconference (VC) is a common clinical tool and has huge potential to alter medical practice and to offer patients the best expertise in treatment and follow-up in spite of long distances, especially in rural areas. Studies upon selected patient groups have shown that VC is safe and cost-effective. However, RCT of VC patients with stoma problems have never been performed. Patients with stoma problems are resource demanding patients. The University Hospital North Norway (UNN) has several hundred consultations for this patient group each year, serving the population in North Norway. Methods: In this randomised controlled trial (RCT), patients are either randomised to a VC consultation or a regular consultation at the outpatient clinic. All patients with a stoma that needs special attention are eligible for inclusion. Patients randomised to the VC group, are set-up to a meeting at the nearest VC studio located to their home community. There will be educated VC- stoma nurses that will participate in the clinical examination at the hospital outpatient clinic and at the rural VC studio. Endpoints: Primary endpoints are patient satisfaction and quality of life. Secondary endpoints are number of consultations and cost effectiveness. Sample size calculations showed that 170 patients had to be included in the trial. The investigators hypothesize that postoperative follow-up of stoma patients by VC will not have any impact on patients' quality of life compared to Hospital outpatient follow-up. Furthermore, the investigators hypothesize that the incremental cost-effectiveness ratio will improve.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 17, 2012
Enrollment StartSep 1, 2011
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.1 years ago

Interventions

Videoconference stoma careother

Stoma patients are randomized to videoconference stoma care or surgical outpatients clinic stoma care