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临床试验/NCT06950567
NCT06950567已完成不适用

Evaluation of the Effectiveness of a Psychoeducational Intervention on Benzodiazepine Use in the Population Over 64 Years Old in Primary Care

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
122
试验地点
2
主要终点
Number of participants who have stopped taking benzodiazepines and/or have reduced their consumption measured in mg/week.

研究概览

简要总结

The goal of this pragmatic, multicenter, randomized controlled trial is to determine whether a multidisciplinary psychoeducational intervention combined with therapeutic exercise is more effective than a minimal educational intervention alone in helping older adults with long-term benzodiazepine use discontinue or reduce their medication.

The main questions it aims to answer are:

Does the multidisciplinary intervention increase the proportion of participants who completely discontinue benzodiazepine treatment? Does the intervention reduce the weekly benzodiazepine dose compared with the minimal intervention alone?

Researchers compared a minimal educational intervention ("Benzocarta") with the same intervention plus an 8-week multidisciplinary psychoeducational program and supervised therapeutic exercise.

Participants:

received a personalized educational letter from their family physician explaining the risks of long-term benzodiazepine use and providing guidance for gradual dose reduction; were randomly assigned either to the control group (minimal intervention only) or to the intervention group (minimal intervention plus psychoeducational sessions and therapeutic exercise); were followed for 6 and 18 months after the initial intervention to assess benzodiazepine discontinuation and changes in weekly dose.

详细描述

Long-term benzodiazepine use is common among older adults despite recommendations limiting treatment duration because of the increased risk of dependence, falls, cognitive impairment and other adverse effects. Although several interventions have been proposed to support benzodiazepine deprescribing, their implementation in routine primary care remains limited.

This pragmatic, multicenter randomized controlled trial was designed to evaluate the effectiveness of a multidisciplinary intervention delivered in routine primary care. The intervention combined a minimal educational strategy consisting of a personalized letter from the participant's family physician ("Benzocarta") with an 8-week group-based psychoeducational program and supervised therapeutic exercise. The comparator group received the minimal educational intervention alone, reflecting usual clinical practice.

The intervention was delivered by a multidisciplinary primary care team and focused on promoting benzodiazepine deprescribing through education, behavioural strategies and non-pharmacological management of insomnia, anxiety and stress.

The study was conducted under real-world conditions in four primary care centres. Although the minimum required sample size was 69 participants, recruitment continued during the planned recruitment period because additional family physicians agreed to participate during the planned recruitment period. Consequently, the final enrolled sample exceeded the minimum target specified in the original protocol (122 participants).

Follow-up assessments were performed at 6 and 18 months after the initial intervention to evaluate the long-term sustainability of benzodiazepine deprescribing and the occurrence of late relapse in benzodiazepine use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥65 years.
  • Current benzodiazepine use for ≥3 months.
  • Ability to provide written informed consent.

排除标准

  • Severe psychiatric disorder, dementia, or epilepsy.
  • Enrollment in a home care program, institutionalization, or palliative care.
  • Language barriers or mobility limitations preventing attendance at the primary care centre.

研究组 & 干预措施

control

Sham Comparator

Mailing a letter by postal mail

干预措施: Control (Other)

Experimental

Active Comparator

Mailing a letter by postal mail along with psycho-educational intervention and therapeutic activity.

干预措施: psycho-educational intervention and therapeutic activity (Other)

结局指标

主要结局

Number of participants who have stopped taking benzodiazepines and/or have reduced their consumption measured in mg/week.

时间窗: From the start of the intervention to six months afterward.

Number of participants who completely discontinued benzodiazepine treatment

时间窗: 6 and 18 months after the initial intervention

Complete discontinuation of prescribed benzodiazepine treatment, defined as the absence of benzodiazepine use at follow-up, regardless of the baseline dose. The outcome was assessed by comparing the proportion of participants who had completely discontinued treatment in the intervention and control groups.

次要结局

  • Change in weekly benzodiazepine dose expressed as diazepam equivalents(6 and 18 months after the initial intervention)

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other
责任方
Principal Investigator
主要研究者

Magi Claveria

Specialist Nurse in Family and Community Nursing

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

研究点 (2)

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