跳至主要内容
临床试验/CTRI/2024/05/067200
CTRI/2024/05/067200进行中(未招募)不适用

Efficacy of nurse delivered brief interventions for tobacco use disorders: A multispecialty open label randomized control trial

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2024年5月21日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
550
试验地点
1
主要终点
Proportion of patients abstinent after intervention (as measured by negative urine cotinine levels)

研究概览

简要总结

Background: Treatment gap for tobacco use disorders is as high as 92%. Training nursing professionals to deliver brief interventions can help is reducing the treatment gap. Evidence for efficacy of such interventions is absent in Indian context.

Novelty: Generating evidence for nurse delivered brief interventions for tobacco use disorders in Indian context will have public health implications.

Objective: The primary objective is to compare the abstinent rates between two groups. The secondary objective is to compare the reduction in tobacco use between the groups and also, to compare the abstinence rates and reduction in the tobacco use among the individual specialties for smokeless and smoking tobacco.

Methods: A prospective, open label, parallel arm, randomized clinical trial in patients with tobacco use disorder attending the OPD of the AIIMS Deoghar in all the participating departments of this study (6 departments), over a period of 24 months. 550 patients with tobacco use disorders, who are currently either smoking or using smokeless tobacco in the last 1 week and fulfilling the inclusion and exclusion criterion will be recruited for the study. Participants will be randomized into group 1 (treatment as usual) and group 2 (treatment as usual with nurse delivered brief intervention). Tobacco use patterns, craving, motivation to quit, urine cotinine level will be assessed at baseline and 4 weeks.

Expected outcome: We expect that proportion of patients abstinent (as measured by negative urine cotinine levels) will be higher among the participants receiving the nurse delivered brief intervention group compared to treatment as usual only group.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients clinically diagnosed with tobacco use disorders according to DSM-5 (19).
  • Patients aged 18-60 years of either sex.
  • Patients who are current tobacco users (using once in last 1 week).
  • Patients giving voluntary written consent for participation.

排除标准

  • Presence of comorbid other substance use disorder in dependence pattern.
  • Critically ill patients or patients in acute emergency
  • Patients already on treatment for tobacco use disorders.

结局指标

主要结局

Proportion of patients abstinent after intervention (as measured by negative urine cotinine levels)

时间窗: Baseline & 28th Day

次要结局

  • • Proportion of patients reduced tobacco use after intervention(• Proportion of abstinent or reduced tobacco in each specialty)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Santanu Nath

All India Institute of Medical Sciences- Deoghar

研究点 (1)

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