Can Connected Devices Increase the Success Rate of Benzodiazepine Withdrawals in the Elderly?

Benzodiazepine Withdrawal Clinical Trial

— BENZO-E-STOP  

Official title:

Can Connected Devices Increase the Success Rate of Benzodiazepine Withdrawals in the Elderly?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04912479
• Other study ID #: RC31/19/0508
• Secondary ID: 2020-A02654-35
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: October 2023
• Source: University Hospital, Toulouse
• Contact: Cécile McCambridge, PharmD, PhD
• Phone: 05 61 77 64 18
• Email: mccambridge.c[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Despite a trivialized use of benzodiazepine (BZD) in elderly people (EP), long-term efficacy is often questioned, and treatment has to be regularly re-examined to avoid side effects. Typical intervention techniques to aid patients in reducing their dosage involve: providing information about BZD, explaining the risks associated with a chronic exposure, and tips for a successful withdrawal. In addition, the usage of a connected device may reinforce the patient's motivation by providing details on the quality of sleep and the number of steps taken (activity). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Unassisted mobility (1/1 for the locomotion item on KATZ Activities of Daily Living scale)
• 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 under legal protection
• Patient refuses to participate
• Patient does not speak French

Related Conditions & MeSH terms

• Benzodiazepine Withdrawal

Intervention

Device:
• connected watch
connected watch that provide to patients with information on their sleep quality and their performed activities

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success to stop or reduce benzodiazepine consumption	success to stop benzodiazepine consumption (no more intake) or reduce benzodiazepine consumption (decrease in dosage of more than 25% or non-daily intake)	6 months