Severe Neurological DisabilitiesHANDI@CCESSNCT03717974
Medico-economic Impact Evaluation in Telemedecine Follow-up in Complement of a Mobile Team in Patients With Neurological Disabilities (HANDI@CCESS)
A study testing Telemedecine follow-up after an intervention at home of the mobile team and Mobile team follow-up after an intervention at home of the mobile team in people with Severe Neurological Disabilities, run by Pôle Saint Hélier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Neurological Disabilities
- What is being tested?
- Telemedecine follow-up after an intervention at home of the mobile team and Mobile team follow-up after an intervention at home of the mobile team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 24 Sep 2018to 25 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Severe Neurological Disabilities
- Being tested
- Telemedecine follow-up after an intervention at home of the mobile team, Mobile team follow-up after an intervention at home of the mobile team
- Keywords
- telemedecine, medico-economic, neurological disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedecine follow-up after an intervention at home of the mobile teamOther
Also called medico-economic analysis
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.
Mobile team follow-up after an intervention at home of the mobile teamOther
Also called medico-economic analysis
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.
| Study group | Role | What they receive |
|---|---|---|
| telemedecine's follow-up | Experimental | Telemedecine follow-up after an intervention at home of the mobile team Receives: 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 Receives: Other: Mobile team follow-up after an intervention at home of the mobile team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical-economic analysis by the calculation of the cost-effectiveness of this organization of care
Cost-effectiveness analysis by ICER (Incremental Cost-Effectiveness Ratio)
Measured: 6 months
Secondary outcomes (8)
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)
Measured: 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.
Measured: 6 months
Pain evaluation
Digital assessment (0 to 10) of pain for communicating patients
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
EVA Satisfaction
Digital assessment (0 to 10) of satisfaction.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start24 Sep 2018
- Primary completion22 Nov 2021
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Neurological DisabilitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, randomized controlled pilot study
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique Mutualiste la Sagesse
- Responsible party
- Sponsor
- Investigators
- Philippe Gallien, Doctor, Principal investigator, Pole Saint-Hélier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717974
- Sponsor's protocol ID
- 2017-A02378-45
- Acronym
- HANDI@CCESS
- Status last verified
- Feb 2021
- First submitted
- 16 Oct 2018
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03717974
- Acronym / sponsor ID
- HANDI@CCESS / 2017-A02378-45
- Conditions
- Severe Neurological Disabilities
- Keywords
- telemedecine, medico-economic, neurological disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Collaborators
- Clinique Mutualiste la Sagesse
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric, randomized controlled pilot study
| Arm | Type | Receives |
|---|---|---|
| telemedecine's follow-up | Experimental | Other: Telemedecine follow-up after an intervention at home of the mobile teamTelemedecine follow-up after an intervention at home of the mobile team |
| mobile team's follow-up | Active comparator | Other: Mobile team follow-up after an intervention at home of the mobile teamMobile team follow-up after an intervention at home of the mobile team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedecine follow-up after an intervention at home of the mobile teamAlso: medico-economic analysisAfter 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 | telemedecine's follow-up |
| Mobile team follow-up after an intervention at home of the mobile teamAlso: medico-economic analysisAfter 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 | mobile team's follow-up |
Primary outcome
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)
8 secondary outcomes
UTAUT (Unified theory of acceptance of technology) questionnaire
Time frame: 6 months
Hospital Anxiety and Depression scale (HAD)
Time frame: 6 months
Pain evaluation
Time frame: 6 months
DN4 scale
Time frame: 6 months
Doloplus scale
Time frame: 6 months
Zarit's score
Time frame: 6 months
Goal Attainment Scale
Time frame: 6 months
EVA Satisfaction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Gallien, Doctor principal investigator
Pole Saint-Hélier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedecine follow-up after an intervention at home of the mobile team and Mobile team follow-up after an intervention at home of the mobile team in people with Severe Neurological Disabilities, run by Pôle Saint Hélier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical-economic analysis by the calculation of the cost-effectiveness of this organization of care (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.