Can Connected Devices Increase the Success Rate of Benzodiazepine Withdrawals in the Elderly? (BENZO-E-STOP)

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.

Study Overview

• Status: Recruiting
• Conditions: Benzodiazepine Withdrawal
• Intervention / Treatment: Device: connected watch

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cécile McCambridge, PharmD, PhD; Phone Number: +33 05 61 77 64 18; Email: mccambridge.c@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • University Hospital of Toulouse
    • Contact: Cécile McCambridge, MD, PhD; Phone Number: +33 05 61 77 64 18; Email: mccambridge.c@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Device: connected watch; connected watch that provide to patients with information on their sleep quality and their performed activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Cécile McCambridge, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RC31/19/0508; 2020-A02654-35 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No