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临床试验/NCT06921278
NCT06921278尚未招募不适用

Psychometric Development of the Alcohol and Drug Respiratory Health Questionnaire and Evaluation of a Lung Health Clinic

King's College London1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2025年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
260
试验地点
1
主要终点
A brief respiratory health screening questionnaire

研究概览

简要总结

The goal of this study is to develop a brief Drug and Alcohol Respiratory Health Test (DARHT) and offer it for routine use in clinical assessment and medical reviews

详细描述

Respiratory diseases are highly prevalent among adults with substance use disorder. Inhaling drugs are risk factors, and cigarette smoking contributes to 90% of COPD cases. The substance use disorders population faces barriers to accessing healthcare, leading to under-diagnosis and including stigma, exacerbating the unmet need for effective respiratory disease management. There is no population-specific screening instrument in NHS and Third Sector addiction services. The lack of a validated screening tool means Respiratory health symptoms may be overlooked or attributed to other causes. The aim of this trial is to develop a brief Drug and Alcohol Respiratory Health Test (DARHT) and make it available for clinical assessment and medical reviews. The primary research question is to determine if the DARHT achieves satisfactory diagnostic accuracy with gold-standard spirometry. The study will be open to any enrolled adult (age >18 years) patients at our treatment clinic (NHS secondary care) who reports inhaling (smoking) tobacco, cannabis, cocaine, opioids, or consuming alcohol in the past 28 days. Volunteer and informed and consenting participants will be invited to: (1) complete a brief study questionnaire that includes the DARHT, then take a spirometry and pulse oximetry test; (2) return to the clinic after 3-7 day to complete the DARHT with a different interviewer. Participants with a positive case evaluation on the DARHT or spirometer will be referred to primary or specialist services. The investigators will contact participants referred after 6 weeks to determine their progress and the PHQ-4 and EQ-5D-L to evaluate changes in quality of life. The first 20 participants referred to specialist care will be invited to a Lung Health Clinic where the investigators will offer a psycho-social intervention for advice and support.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

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

入选标准

  • >18 (no upper age limit)
  • Inhalation (smoking) of tobacco, or cannabis, or cocaine, or opioids, or use of alcohol in the past 28 days
  • Possession of a personal mobile phone to arrange follow-up appointments

排除标准

  • Reported physical health condition that would mean spirometry contra-indicated - including heart attack, unstable angina, pulmonary embolism,
  • Reported surgery in the past 3 months for an eye, chest, or abdominal condition that would mean spirometry contra-indicated
  • Likely inability to complete study due to criminal justice involvement with legal proceedings risking incarceration

结局指标

主要结局

A brief respiratory health screening questionnaire

时间窗: Day 1 and Day 3-7

To investigate the accuracy of a brief respiratory health screening questionnaire in highlighting respiratory health symptoms in participants with Substance Use Disorders.

次要结局

  • Specialist nurse and psychology assistant delivered Lung Health Clinic(Week 1 to Week 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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