Videoconference Stoma Consultation

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01600508
First received: April 3, 2012
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Surgical Stomas
Other: Videoconference stoma care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Videoconference in Stoma Out-patient Clinic. A Randomized Controlled Trial

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Changes in quality of life [ Time Frame: up to two years ] [ Designated as safety issue: No ]
    We aim to compare quality of life measured with EQ-5D questionnaires among patients followed up by VC vs those followed up at the surgical outpatient clinic at 1, 3, 6, 9, 12, 15, 18, 21, 24 months of follow-up. We hypothesize that patients followed up by VC will experience similar or higher scores on quality of life measures during followup.


Secondary Outcome Measures:
  • Cost effectiveness [ Time Frame: up to two years ] [ Designated as safety issue: No ]
    Economic evaluation questionnaire, incorporated in the QOL questionnaire, is given to the patients and requested to fill out at baseline and at 1, 3 6, 9, 12, 15, 18, 21 and 24 months after inclusion. It has been developed to enable calculation of costs related to patient examinations such as patient- and family-related costs due to outpatient visits, VC visits, laboratory tests, radiographs/ultrasound, examinations due stoma complications, treatment of complications, traveling, production losses, co-payments and other patient expenses.


Estimated Enrollment: 170
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional stoma care
Being discharged from a hospital with a stoma is a challenge to the patient's quality of life in many aspects. Optimal stoma function and care is essential to keep quality of life best possible. Videoconference can be a useful tool to help patients cope with stoma problems without travelling long distances to a surgical outpatient clinic.
Other: Videoconference stoma care
Stoma patients are randomized to videoconference stoma care or surgical outpatients clinic stoma care
Experimental: Videoconference Stoma Consultations
Videoconference Stoma Consultations
Other: Videoconference stoma care
Stoma patients are randomized to videoconference stoma care or surgical outpatients clinic stoma care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stoma patients

Exclusion Criteria:

  • Not able to travel,
  • Accepted written consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600508

Sponsors and Collaborators
University Hospital of North Norway
Investigators
Principal Investigator: Rolv-Ole Lindsetmo, MD, PhD, MPH Institute of Clinical Medicine, Tromsø University, Norway, Univertsity Hospital of North Norway
  More Information

Publications:

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01600508     History of Changes
Other Study ID Numbers: 2009/1432a (REK)
Study First Received: April 3, 2012
Last Updated: May 16, 2012
Health Authority: Norway: Data Protection Authority

Keywords provided by University Hospital of North Norway:
stoma care
videoconference
costs
quality of life

ClinicalTrials.gov processed this record on July 24, 2014