Telemedicine Versus Standard Follow-Up Care for Diabetes-Related Foot Ulcers: Protocol for a Cluster Randomized Controlled Noninferiority Trial (DiaFOTo)

Abstract

BackgroundThis 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.ObjectiveTo present the design and methods of a study evaluating a telemedicine follow-up intervention for patients with diabetes-related foot ulcers.MethodsThe 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.ResultsThe 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.ConclusionsThis 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.Trial RegistrationClinicalTrials.gov NCT01710774; https://clinicaltrials.gov/ct2/...

Telemedicine follow‐up facilitates more comprehensive diabetes foot ulcer care: A qualitative study in home‐based and specialist health care

“…The healthcare professionals were recruited from the intervention arm in the ongoing cluster RCT to ensure that they were all applying a similar form of telemedicine (Iversen et al., ). We used purposive sampling of healthcare professionals in both home‐based care and in an outpatient clinic.…”

“…This qualitative study was conducted in alignment with a large cluster randomised controlled trial (RCT). The RCT was designed to investigate clinical outcomes associated with telemedicine follow‐up care for people with diabetic foot ulcers in outpatient clinics in specialist hospital care in collaboration with primary health care (Iversen et al., ). The telemedicine intervention for this RCT consisted of an interactive telemedicine platform with a web‐based ulcer record combined with a mobile phone, enabling counselling and communication between nurses in the community and specialist health care (Iversen et al., ).…”

“…The RCT was designed to investigate clinical outcomes associated with telemedicine follow‐up care for people with diabetic foot ulcers in outpatient clinics in specialist hospital care in collaboration with primary health care (Iversen et al., ). The telemedicine intervention for this RCT consisted of an interactive telemedicine platform with a web‐based ulcer record combined with a mobile phone, enabling counselling and communication between nurses in the community and specialist health care (Iversen et al., ). A recent qualitative analysis conducted in conjunction with this RCT indicated that the health professionals to some extent experienced and applied telemedicine differently according to where they worked (Kolltveit et al., ).…”

Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: Secondary outcomes from a cluster randomized controlled trial (DiaFOTo)

“…The design of the study has been described previously [9,10]. Brie y, this was a multicenter cluster-randomized controlled noninferiority trial.…”

Effect of Internet technology on extended care in elderly patients with diabetic feet

“…13 The expert team consisted of clinical nurse specialists who had senior professional titles, a wealth of clinical experience, accurate comprehensive assessment capabilities and superb professional skills. The experts had a profound understanding of the patients when they were hospitalized and provided a continuous professional diabetic foot ulcer care program after discharge.…”