title: Telemedicine Versus Standard Follow-Up Care for Diabetes-Related Foot Ulcers: Protocol for a Cluster Randomized Controlled Noninferiority Trial (DiaFOTo).
abstract: BACKGROUND
  This paper presents the protocol for an ongoing study to evaluate a telemedicine follow-up intervention for patients with diabetes-related foot ulcers. Diabetes-related foot ulcers represent challenges for patients and the health services. The large increase in the prevalence of diabetes, combined with the aging population, means that the absolute number of patients with diabetes-related foot ulcers is likely to continue to increase. Health care services therefore need to provide close clinical follow-up care for people with diabetes both in primary and specialist care. Information and communication technologies may enable more integrated treatment and care pathways across organizational boundaries. However, we lack knowledge about the effect of telemedicine follow-up and how such services can be optimally organized.
  
  
  OBJECTIVE
  To present the design and methods of a study evaluating a telemedicine follow-up intervention for patients with diabetes-related foot ulcers.
  
  
  METHODS
  The study is designed as a cluster randomized controlled trial (noninferiority trial) involving municipalities or municipality districts (clusters) belonging to one clinical site in Western Norway. The study includes patients with type 1 and type 2 diabetes presenting with a new foot ulcer at the initial visit to the clinic. Patients in the intervention group receive telemedicine follow-up care in the community. The key ingredient in the intervention is the close integration between health care levels. The intervention is facilitated by the use of an interactive wound platform consisting of a Web-based ulcer record combined with a mobile phone, enabling counseling and communication between nurses in the community and specialist health care. Patients in the control group receive standard hospital outpatient care. The primary endpoint in the trial is healing time; secondary outcomes include amputation and death, patient-reported outcome measures, and follow-up data on the recurrence of foot ulcers. In addition, qualitative substudies are being performed to provide a more comprehensive evaluation of the ongoing processes during the trial with the patients in the intervention and control groups and those health care professionals either working in primary care or in specialist care delivering the intervention.
  
  
  RESULTS
  The project has been funded. The inclusion of patients started in September 2012. Because recruitment goals were not met in the initial period, two more clinical sites have been included to meet sample size requirements. Patient recruitment will continue until June 2016. Data collection in the qualitative substudies has been completed.
  
  
  CONCLUSIONS
  This telemedicine trial operates in a novel setting and targets patients with diabetes-related foot ulcers during a 12-month follow-up period. The trial addresses whether integrated care using telemedicine between primary and specialist health care can be an equivalent alternative to standard outpatient care.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01710774; https://clinicaltrials.gov/ct2/show/NCT01710774 (Archived by WebCite at http://www.webcitation.org/6im6KfFov).
authors.affiliation: Centre for Evidence-Based Practice, Faculty of Health and Social Sciences, Bergen University College, Bergen, Norway. miv@hib.no.
authors.forename: Marjolein M
authors.identifier: http://orcid.org/0000-0001-9954-171X
authors.initials: MM
authors.lastname: Iversen
authors.forename: Birgitte
authors.identifier: http://orcid.org/0000-0002-7287-8643
authors.initials: B
authors.lastname: Espehaug
authors.forename: Marie F
authors.identifier: http://orcid.org/0000-0001-6185-6994
authors.initials: MF
authors.lastname: Hausken
authors.forename: Marit
authors.identifier: http://orcid.org/0000-0002-3149-6227
authors.initials: M
authors.lastname: Graue
authors.forename: Truls
authors.identifier: http://orcid.org/0000-0002-0662-7440
authors.initials: T
authors.lastname: Østbye
authors.forename: Svein
authors.identifier: http://orcid.org/0000-0001-6460-9622
authors.initials: S
authors.lastname: Skeie
authors.forename: John G
authors.identifier: http://orcid.org/0000-0002-1753-635X
authors.initials: JG
authors.lastname: Cooper
authors.forename: Grethe S
authors.identifier: http://orcid.org/0000-0003-1386-1638
authors.initials: GS
authors.lastname: Tell
authors.forename: Bodo Erhardt
authors.identifier: http://orcid.org/0000-0003-3540-7444
authors.initials: BE
authors.lastname: Günther
authors.forename: Håvard
authors.identifier: http://orcid.org/0000-0002-2962-2706
authors.initials: H
authors.lastname: Dale
authors.forename: Hilde
authors.identifier: http://orcid.org/0000-0001-6719-1401
authors.initials: H
authors.lastname: Smith-Strøm
authors.forename: Beate-Christin H
authors.identifier: http://orcid.org/0000-0002-2704-6493
authors.initials: BC
authors.lastname: Kolltveit
authors.forename: Marit
authors.identifier: http://orcid.org/0000-0002-3979-0631
authors.initials: M
authors.lastname: Kirkevold
authors.forename: Berit
authors.identifier: http://orcid.org/0000-0002-4549-4900
authors.initials: B
authors.lastname: Rokne
keywords: Norway; cluster RCT; complex intervention; delivery of health care, integrated; diabetes; diabetic foot; foot ulcer; patient-reported outcomes; primary care; randomized controlled trial; telemedicine