Can Connected Devices Increase the Success Rate of Benzodiazepine Withdrawals in the Elderly?
NCT ID: NCT04912479
Last Updated: 2024-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2021-10-14
2026-02-01
Brief Summary
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Participants will be identified during a 12-month period through either external geriatric consultations or during a brief hospitalisation.
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Detailed Description
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This is a prospective randomized open study, which aims to evaluate the benefit of a connected watch to help people aged 65 years and older to withdraw from BZD over a six-month period, compared with classical withdrawal (e.g without connected watch). The study will include 100 patients, 50 in the control group and 50 in the intervention group.
Participants will be identified during a 12-month period through either external geriatric consultations or during a brief hospitalisation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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control
Patients will be given a plan to reduce progressively their dosage of Benzodiazepin every 2 weeks. Over a 6-month period they will receive a phone call from the hospital twice a month to reinforce their motivation.
No interventions assigned to this group
intervention group
In addition to the progressive withdrawal of BZD, patients will be given a connected watch that provide them with information on their sleep quality and their performed activities. They will also receive a check-up phone call twice a month over a 6-month period.
connected watch
connected watch that provide to patients with information on their sleep quality and their performed activities
Interventions
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connected watch
connected watch that provide to patients with information on their sleep quality and their performed activities
Eligibility Criteria
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Inclusion Criteria
* Mini-Mental State Examination (MMSE) ≥ 20
* With a daily consumption of benzodiazepine for more than 3 months
* Smartphone and/or tablet with internet connection
Exclusion Criteria
* Patient refuses to participate
* Patient does not speak French
65 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Cécile McCambridge
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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University Hospital of Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-A02654-35
Identifier Type: OTHER
Identifier Source: secondary_id
RC31/19/0508
Identifier Type: -
Identifier Source: org_study_id
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