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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Benzodiazepine Withdrawal

Intervention / Treatment
-----------------
* Device: connected watch


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>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<br>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<br>* connected watch that provide to patients with information on their sleep quality and their performed activities<br>|

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 |