Benzodiazepine Withdrawal
Conditions
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.
Interventions
DEVICEconnected watch
connected watch that provide to patients with information on their sleep quality and their performed activities
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| success to stop or reduce benzodiazepine consumption | 6 months | success to stop benzodiazepine consumption (no more intake) or reduce benzodiazepine consumption (decrease in dosage of more than 25% or non-daily intake) |
Countries
France
Contacts
Primary ContactCécile McCambridge, PharmD, PhD
Outcome results
None listed