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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03717974
Acronym
HANDI@CCESS
Enrollment
80
Registered
2018-10-24
Start date
2018-09-24
Completion date
2022-01-25
Last updated
2022-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Neurological Disabilities

Keywords

telemedecine, medico-economic, neurological disability

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.

Interventions

OTHERTelemedecine 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.

OTHERMobile 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.

Sponsors

Clinique Mutualiste la Sagesse
CollaboratorOTHER
Pôle Saint Hélier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Monocentric, randomized controlled pilot study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Medical-economic analysis by the calculation of the cost-effectiveness of this organization of care6 monthsCost-effectiveness analysis by ICER (Incremental Cost-Effectiveness Ratio)

Secondary

MeasureTime frameDescription
Hospital Anxiety and Depression scale (HAD)6 monthsIt 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.
Pain evaluation6 monthsDigital assessment (0 to 10) of pain for communicating patients
DN4 scale6 monthsDigital assessment of neuropathic pain for communicating patients. If the patient score is equal to or greater than 4/10, the test is positive.
UTAUT (Unified theory of acceptance of technology) questionnaire6 monthsQuestionnaire of acceptability / acceptance of the tool and its use by professionals based on the Unified Theory of Acceptance and Use Technology (UTAUT)
Zarit's score6 monthsThe 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.
Goal Attainment Scale6 monthsGoal 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.
EVA Satisfaction6 monthsDigital assessment (0 to 10) of satisfaction.
Doloplus scale6 monthsBehavioral 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026