Telemedicine Versus Standard Follow-Up Care for Diabetes-Related Foot Ulcers: Protocol for a Cluster Randomized Controlled Noninferiority Trial (DiaFOTo)
Bibliographic record
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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01710774; https://clinicaltrials.gov/ct2/show/NCT01710774 (Archived by WebCite at http://www.webcitation.org/6im6KfFov).
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.011 | 0.007 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".