NCT03717974

Brief Summary

Access to care for people with traumatic or degenerative neurological disabilities is a current public health concern. New technological tools such as telemedicine can bring expertise to the place of life of people while promoting the city-hospital link.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

September 24, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2021

Enrollment Period

3.2 years

First QC Date

October 16, 2018

Last Update Submit

February 10, 2022

Conditions

Severe Neurological Disabilities

Keywords

telemedecinemedico-economicneurological disability

Outcome Measures

Primary Outcomes (1)

  • Medical-economic analysis by the calculation of the cost-effectiveness of this organization of care

    Cost-effectiveness analysis by ICER (Incremental Cost-Effectiveness Ratio)

    6 months

Secondary Outcomes (8)

  • UTAUT (Unified theory of acceptance of technology) questionnaire

    6 months

  • Hospital Anxiety and Depression scale (HAD)

    6 months

  • Pain evaluation

    6 months

  • DN4 scale

    6 months

  • Doloplus scale

    6 months

  • +3 more secondary outcomes

Study Arms (2)

telemedecine's follow-up

EXPERIMENTAL

Telemedecine follow-up after an intervention at home of the mobile team

Other: Telemedecine follow-up after an intervention at home of the mobile team

mobile team's follow-up

ACTIVE COMPARATOR

Mobile team follow-up after an intervention at home of the mobile team

Other: Mobile team follow-up after an intervention at home of the mobile team

Interventions

Telemedecine follow-up after an intervention at home of the mobile teamOTHER

After a first visit of the mobile team at home, patients are followed by telemedicine. Moreover, in case of pain, a specialized consultation by an algologist of "La Sagesse" will be realized.

Also known as: medico-economic analysis
telemedecine's follow-up
Mobile team follow-up after an intervention at home of the mobile teamOTHER

After a first visit of the mobile team at home, patients are followed by mobile team. Moreover, in case of pain, a specialized consultation by an algologist of "La Sagesse" will be realized.

Also known as: medico-economic analysis
mobile team's follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18
  • Volunteer to participate in the study and whose primary caregiver is voluntary
  • Presenting a severe neurological handicap following a neurological lesion of traumatic, vascular or degenerative origin,
  • Requiring an expert opinion in MPR (rehabilitation, technical and human compensatory means, specific treatments ...) and / or in algology
  • Whose access to care is reduced (difficulties of movement, distance from expert centers, situation of fragility ...) and which necessitate the displacement of professionals at home,
  • Which require a coordination of care associating the professionals of the sanitary and medico-social sectors
  • Living in health territory 5 in Brittany
  • Mastering the French language spoken and / or written.

You may not qualify if:

  • Misunderstanding making it impossible for informed consent with the refusal of the guardian or court safeguard
  • Unable to use a digital tablet or lack of a resource person who can assist the patient in the use of the tablet
  • Patients who do not have access to an internet connection (white area)
  • Life threatening is committed in the short term (\< 3 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pôle Saint-Hélier

Rennes, 35000, France

Location

Study Officials

  • Philippe Gallien, Doctor

    Pole Saint-Hélier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Monocentric, randomized controlled pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2018

First Posted

October 24, 2018

Study Start

September 24, 2018

Primary Completion

November 22, 2021

Study Completion

January 25, 2022

Last Updated

February 11, 2022

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)