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

NCT04912479 | Recruiting

• 2 other identifiers: RC31/19/05082020-A02654-35
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benzodiazepine Withdrawal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

control

NO INTERVENTION

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.

intervention group

EXPERIMENTAL

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

Interventions

connected watch DEVICE

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

intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient under legal protection
• Patient refuses to participate
• Patient does not speak French

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, France

RECRUITING

Study Officials

• Cécile McCambridge

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile McCambridge, PharmD, PhD

CONTACT

33-561776418; mccambridge.c@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: October 14, 2021
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)