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

Toulouse University Hospital

Status: Enrolling

Conditions: Benzodiazepine Withdrawal

Treatments: Device: connected watch

Study type: Interventional

Funder types: Other

Identifiers

NCT04912479

RC31/19/0508

2020-A02654-35 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: connected watch