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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) (HANDI@CCESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717974
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Clinique Mutualiste La Sagesse
Information provided by (Responsible Party):
Pôle Saint Hélier

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.

Condition or disease Intervention/treatment Phase
Severe Neurological Disabilities 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Monocentric, randomized controlled pilot study
Masking: None (Open Label)
Primary Purpose: Other
Official 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)
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : September 24, 2020
Estimated Study Completion Date : September 24, 2020

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 Name: 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 Name: medico-economic analysis




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717974


Contacts
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Contact: Philippe Gallien, Doctor 0299295088 philippe.gallien@pole-sthelier.com
Contact: Aurélie Duruflé, Doctor 0299295088 aurelie.durufle@pole-sthelier.com

Locations
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France
Pôle Saint-Hélier Recruiting
Rennes, France, 35000
Contact: Gallien Philippe, Doctor    0299295088    philippe.gallien@pole-sthelier.com   
Sponsors and Collaborators
Pôle Saint Hélier
Clinique Mutualiste La Sagesse
Investigators
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Principal Investigator: Philippe Gallien, Doctor Pole Saint-Hélier

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Responsible Party: Pôle Saint Hélier
ClinicalTrials.gov Identifier: NCT03717974    
Other Study ID Numbers: 2017-A02378-45
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pôle Saint Hélier:
telemedecine
medico-economic
neurological disability
Additional relevant MeSH terms:
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Complement System Proteins
Immunologic Factors
Physiological Effects of Drugs