Medico-economic Impact Evaluation in Telemedecine Follow-up in Complement of a Mobile Team in Patients With Neurological Disabilities (HANDI@CCESS) (HANDI@CCESS)

Randomized Controlled Pilot Study for Medico-economic Impact Evaluation in Telemedecine Follow-up in Complement of a Mobile Team in Patients With Neurological Disabilities (HANDI@CCESS)

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.

Study Overview

• Status: Completed
• Conditions: Severe Neurological Disabilities
• Intervention / Treatment: Other: Telemedecine 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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • Pôle Saint-Hélier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: telemedecine's follow-up; 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; 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.; Other Names: medico-economic analysis
ACTIVE_COMPARATOR: mobile team's follow-up; 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; 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.; Other Names: medico-economic analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
UTAUT (Unified theory of acceptance of technology) questionnaire	Questionnaire of acceptability / acceptance of the tool and its use by professionals based on the Unified Theory of Acceptance and Use Technology (UTAUT)	6 months
Hospital Anxiety and Depression scale (HAD)	It can detect anxiety and depressive disorders. It has 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus obtaining two scores (maximum score of each score = 21). 7 or less: no symptomatology 8 to 10: doubtful symptomatology 11 and above: certain symptomatology.	6 months
Pain evaluation	Digital assessment (0 to 10) of pain for communicating patients	6 months
DN4 scale	Digital assessment of neuropathic pain for communicating patients. If the patient score is equal to or greater than 4/10, the test is positive.	6 months
Doloplus scale	Behavioral Assessment Scale of Pain in Older People with Verbal Communication Disorders. This scale comprises ten items divided into three subgroups (five somatic, two psychomotor and three psychosocial). Each item is rated from 0 to 3 (four exclusive and progressive level scoring), which results in an overall score between 0 and 30. The pain is clearly affirmed for a score greater than or equal to 5 out of 30.	6 months
Zarit's score	The Zarit scale assesses the emotional, physical and financial burden for caregivers of caring for someone with a loss of autonomy. The total score, which is the sum of the scores obtained for each of 22 items, varies from 0 to 88. A score less than or equal to 20 indicates a low or no load; a score between 21 and 40 indicates a light load; a score between 41 and 60 indicates a moderate load; a score above 60 indicates a severe charge.	6 months
Goal Attainment Scale	Goal Attainment Scale by objectives at the beginning and end of taking charge. Each item built has 5 levels of answers 0: corresponds to the achievement of the goal set by the examiner.; 1: is a better score than expected.; 2: corresponds to the most favorable evolution expected.1: corresponds to a score lower than that expected.2: corresponds to a least favorable score expected.	6 months
EVA Satisfaction	Digital assessment (0 to 10) of satisfaction.	6 months

Collaborators and Investigators

• Sponsor: Pôle Saint Hélier
• Collaborators: Clinique Mutualiste la Sagesse

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 24, 2018
• Primary Completion (ACTUAL): November 22, 2021
• Study Completion (ACTUAL): January 25, 2022

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (ACTUAL): October 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: medico-economic; neurological disability; telemedecine
• Other Study ID Numbers: 2017-A02378-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No