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Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management (AIRPEDIA)

Primary Purpose

Diabetes, Diabetic Foot Ulcer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
telemedicine
conventional
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring innovative care, telemedicine, cost effectiveness, diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with type 1 or 2 diabetes, at least 18 years old

  • Patient with a diabetic foot wound :

    • Acute or chronic (evolving for at least 30 days)
    • size ≤ to 3 cm²
    • Level I, II or III, stage A or B, excluding stages C and D from the University of Texas Wound Classification Systems
  • Person affiliated to French Health insurance or equivalent
  • Person having signed freely the consent form after receiving sufficient information
  • Treatment compliance and 6 months follow-up feasible

Exclusion Criteria:

  • Patient with a ischemic wound: Ankle-Brachial Index (ABI) <0.9 or Transcutaneous oxygen pressure (TcpO2) < 30 mmHg (stage C and D from the University of Texas Wound Classification Systems)
  • Patient with emergency hospitalization indication whatever the reasons.
  • Person deprived of liberty by a legal or administrative decision, patients in emergency and people hospitalised without consent and who are not protected by law.
  • Pregnant or breastfeeding women
  • Patient currently participating in another telemedicine research protocol (such as : Study on the impact of Telemedicine on the management of patients with type 1 diabetes (TELEDIAB-3))

Sites / Locations

  • University Hospital of Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telemedicine

Conventional care

Arm Description

care and follow-up through telemedicine.

care and follow-up through iterative diabetes physician consultations (conventional care and follow-up)

Outcomes

Primary Outcome Measures

Assess the incremental cost-effectiveness ratio from the french health system perspective
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.

Secondary Outcome Measures

Assess the Impact of telemedicine care from the hospital perspective
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.
Acceptability questionnaire for nurse including use or misuse of telemedicine. Acceptability questionnaire for patient.

Full Information

First Posted
March 15, 2013
Last Updated
May 24, 2018
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT01814267
Brief Title
Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management
Acronym
AIRPEDIA
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetic Foot Ulcer
Keywords
innovative care, telemedicine, cost effectiveness, diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
care and follow-up through telemedicine.
Arm Title
Conventional care
Arm Type
Active Comparator
Arm Description
care and follow-up through iterative diabetes physician consultations (conventional care and follow-up)
Intervention Type
Other
Intervention Name(s)
telemedicine
Intervention Description
Intervention group: care and follow-up through telemedicine (e-consultations) 1 hospital consultation at inclusion time, week 0 then every 15 days, after the transmission of medical data and photos via internet by the nurse, telemedicine e-consultations until the wound has healed (week 2,week 4, week 6, week 8, week 10, week 12, week 14, week 16, week 18, week 20, week 22, week 24 : end point study), i.e. 12 e-consultations over a 6-month period. 1 hospital consultation to validate that the wound is well-healed
Intervention Type
Other
Intervention Name(s)
conventional
Intervention Description
conventional group: iterative diabetes physicians consultations at hospital 1 consultation at inclusion time, week 0 1 consultation 2 weeks after inclusion, week 2 1 consultation per month until the wound has healed (week 4, week 8, week 12, week 16, week 20, week 24: end-point study), i.e. 6 consultations over a 6-month period 1 consultation to validate that the wound is well-healed
Primary Outcome Measure Information:
Title
Assess the incremental cost-effectiveness ratio from the french health system perspective
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Assess the Impact of telemedicine care from the hospital perspective
Description
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
Time Frame
6 months
Title
Assess acceptability of telemedicine care (compliance and satisfaction) for patients and nurses.
Description
Acceptability questionnaire for nurse including use or misuse of telemedicine. Acceptability questionnaire for patient.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with type 1 or 2 diabetes, at least 18 years old Patient with a diabetic foot wound : Acute or chronic (evolving for at least 30 days) size ≤ to 3 cm² Level I, II or III, stage A or B, excluding stages C and D from the University of Texas Wound Classification Systems Person affiliated to French Health insurance or equivalent Person having signed freely the consent form after receiving sufficient information Treatment compliance and 6 months follow-up feasible Exclusion Criteria: Patient with a ischemic wound: Ankle-Brachial Index (ABI) <0.9 or Transcutaneous oxygen pressure (TcpO2) < 30 mmHg (stage C and D from the University of Texas Wound Classification Systems) Patient with emergency hospitalization indication whatever the reasons. Person deprived of liberty by a legal or administrative decision, patients in emergency and people hospitalised without consent and who are not protected by law. Pregnant or breastfeeding women Patient currently participating in another telemedicine research protocol (such as : Study on the impact of Telemedicine on the management of patients with type 1 diabetes (TELEDIAB-3))
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Yves BENHAMOU, MD PHD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Grenoble
City
Grenoble
ZIP/Postal Code
38049
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22067285
Citation
Hazenberg CE, Bus SA, Kottink AI, Bouwmans CA, Schonbach-Spraul AM, van Baal SG. Telemedical home-monitoring of diabetic foot disease using photographic foot imaging--a feasibility study. J Telemed Telecare. 2012 Jan;18(1):32-6. doi: 10.1258/jtt.2011.110504. Epub 2011 Nov 8.
Results Reference
background
PubMed Identifier
21568750
Citation
Foltynski P, Ladyzynski P, Migalska-Musial K, Sabalinska S, Ciechanowska A, Wojcicki J. A new imaging and data transmitting device for telemonitoring of diabetic foot syndrome patients. Diabetes Technol Ther. 2011 Aug;13(8):861-7. doi: 10.1089/dia.2011.0004. Epub 2011 May 13.
Results Reference
background
PubMed Identifier
21134035
Citation
Bowling FL, King L, Paterson JA, Hu J, Lipsky BA, Matthews DR, Boulton AJ. Remote assessment of diabetic foot ulcers using a novel wound imaging system. Wound Repair Regen. 2011 Jan-Feb;19(1):25-30. doi: 10.1111/j.1524-475X.2010.00645.x. Epub 2010 Dec 6.
Results Reference
background
PubMed Identifier
17059653
Citation
Larsen SB, Clemensen J, Ejskjaer N. A feasibility study of UMTS mobile phones for supporting nurses doing home visits to patients with diabetic foot ulcers. J Telemed Telecare. 2006;12(7):358-62. doi: 10.1258/135763306778682323.
Results Reference
background
PubMed Identifier
15192491
Citation
Wilbright WA, Birke JA, Patout CA, Varnado M, Horswell R. The use of telemedicine in the management of diabetes-related foot ulceration: a pilot study. Adv Skin Wound Care. 2004 Jun;17(5 Pt 1):232-8. doi: 10.1097/00129334-200406000-00012.
Results Reference
background
PubMed Identifier
26696670
Citation
Muller M, David-Tchouda S, Margier J, Oreglia M, Benhamou PY. Comment on Rasmussen et al. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers. Diabetes Care 2015;38:1723-1729. Diabetes Care. 2016 Jan;39(1):e9-10. doi: 10.2337/dc15-1659. No abstract available.
Results Reference
result

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Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management

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