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Completed

NCT Number: NCT03717974

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.

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Key information

Conditions

Severe Neurological Disabilities

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pôle Saint-Hélier

Rennes, 35000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other

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

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

Other

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

Primary outcomes

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

    Time frame: 6 months

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

Secondary outcomes

  1. UTAUT (Unified theory of acceptance of technology) questionnaire

    Time frame: 6 months

    Questionnaire of acceptability / acceptance of the tool and its use by professionals based on the Unified Theory of Acceptance and Use Technology (UTAUT)

  2. Hospital Anxiety and Depression scale (HAD)

    Time frame: 6 months

    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.

  3. Pain evaluation

    Time frame: 6 months

    Digital assessment (0 to 10) of pain for communicating patients

  4. DN4 scale

    Time frame: 6 months

    Digital assessment of neuropathic pain for communicating patients. If the patient score is equal to or greater than 4/10, the test is positive.

  5. Doloplus scale

    Time frame: 6 months

    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. Zarit's score

    Time frame: 6 months

    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.

  7. Goal Attainment Scale

    Time frame: 6 months

    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.

  8. EVA Satisfaction

    Time frame: 6 months

    Digital assessment (0 to 10) of satisfaction.

Sponsors and collaborators

Lead sponsor

Pôle Saint Hélier

Other

Collaborators

  • Clinique Mutualiste la Sagesse

Registry information

Official study title

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)

Acronym: HANDI@CCESS

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Oct 24, 2018
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.