NCT02309905

Brief Summary

The purpose of this study is to determine whether Tele-expertise would be effective and cost-effective by reducing the number of secure transportations for inmates in need of a dermatological consultation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 15, 2016

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

November 27, 2014

Last Update Submit

January 14, 2016

Conditions

Skin Disease

Keywords

inmatesskin lesiontelemedicine

Outcome Measures

Primary Outcomes (1)

  • Proportion of a dermatological expertise among those required

    1 month after the end of the study

Secondary Outcomes (4)

  • Number of hospitalizations for a dermatological reason

    1 month after the end of the study

  • Overall costs

    6 months after the end of the study

  • Time to a dermatological expertise

    1 month after the end of the study

  • Number of usual consultations needed after Tele-expertise

    1 month after the end of the study

Study Arms (4)

Control group before telemedicine

Inmates of prisons not having telemedicine before implementation of telemedicine in prisons having telemedicine

Control group after telemedicine

Inmates of prisons not having telemedicine after implementation of telemedicine in prisons having telemedicine

Exposed group, before telemedicine

Inmates of prisons having telemedicine before implementation of telemedicine

Exposed group, after telemedicine

Inmates of prisons having telemedicine after implementation of telemedicine

Device: Telemedicine

Interventions

TelemedicineDEVICE

Inmates of prisons having telemedicine after implementation of telemedicine

Exposed group, after telemedicine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inmates

You may qualify if:

  • Dermatological expertise required

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UCSA Osny

Cergy-Pontoise, 95524, France

Location

UCSA Meaux

Meaux, 77351, France

Location

UCSA Nanterre

Nanterre, 92014, France

Location

UCSA Réau

Réau, 77550, France

Location

UCSA Villepinte

Villepinte, 93420, France

Location

Related Publications (3)

  • Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.

    PMID: 22617736BACKGROUND

  • Zarca K, Charrier N, Mahe E, Guibal F, Carton B, Moreau F, Durand-Zaleski I. Tele-expertise for diagnosis of skin lesions is cost-effective in a prison setting: A retrospective cohort study of 450 patients. PLoS One. 2018 Sep 24;13(9):e0204545. doi: 10.1371/journal.pone.0204545. eCollection 2018.

    PMID: 30248151DERIVED

  • Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

    PMID: 26857558DERIVED

Related Links

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

  • François Moreau, MD

    Versailles Hospital

    PRINCIPAL INVESTIGATOR

  • Isabelle Durand-Zaleski, MD, PhD

    DRCD URC Eco. Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2014

First Posted

December 5, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

January 15, 2016

Record last verified: 2015-12

Locations

FR(5)