Can Connected Devices Increase the Success Rate of Benzodiazepine Withdrawals in the Elderly?
- Conditions
- Benzodiazepine Withdrawal
- Interventions
- Device: connected watch
- Registration Number
- NCT04912479
- Lead Sponsor
- University Hospital, Toulouse
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- Patient under legal protection
- Patient refuses to participate
- Patient does not speak French
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention group connected watch 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.
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital of Toulouse
🇫🇷Toulouse, France