Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management (AIRPEDIA)
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|ClinicalTrials.gov Identifier: NCT01814267|
Recruitment Status : Completed
First Posted : March 19, 2013
Last Update Posted : May 29, 2018
The aim of the study is to assess the cost-effectiveness of telemedicine in the care of chronic diabetic foot ulcers.
Patients will be randomized into 2 groups: 1/conventional care group with iterative visits to diabetes specialist or 2/innovative care (telemedicine group).
the health insurance system perspective is adopted.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetic Foot Ulcer||Other: telemedicine Other: conventional||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||March 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
care and follow-up through telemedicine.
Intervention group: care and follow-up through telemedicine (e-consultations)
Active Comparator: Conventional care
care and follow-up through iterative diabetes physician consultations (conventional care and follow-up)
conventional group: iterative diabetes physicians consultations at hospital
- Assess the incremental cost-effectiveness ratio from the french health system perspective [ Time Frame: 6 months ]
It is elaborated from:
- Main cost criteria: transport, outpatient costs (home nursing care, physicians consultations...), loss of productivity (absence from work)
- Main clinical effectiveness criterion: wound healing time.
- Assess the Impact of telemedicine care from the hospital perspective [ Time Frame: 6 months ]
The incremental cost-effectiveness ratio is calculated from the hospital perspective:
Main cost criteria will be collected according to the micro-costing method: costs of innovative medical device (implementation and maintenance of telemedicine platform), telemedicine physician consultations, standard consumables, cost of care rooms and cost of medical and paramedical staff and, standard consumables for wound treatment.
Costs will not include structural costs
- Main clinical effectiveness criterion: wound healing time
- Assess acceptability of telemedicine care (compliance and satisfaction) for patients and nurses. [ Time Frame: 6 months ]Acceptability questionnaire for nurse including use or misuse of telemedicine. Acceptability questionnaire for patient.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814267
|University Hospital of Grenoble|
|Grenoble, France, 38049|
|Principal Investigator:||Pierre-Yves BENHAMOU, MD PHD||University Hospital, Grenoble|