Clinical trial NCT06921278: Development of the Drug and Alcohol Respiratory Health Test
Official title: Psychometric Development of the Alcohol and Drug Respiratory Health Questionnaire and Evaluation of a Lung Health Clinic
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Respiratory Disease
Substance-Related Disorders
COPD
Asthma
Lung Cancer
Tuberculosis
Bronchitis
Pneumonia
Obstructive Sleep Apnea
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2025-04-10
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Addictions Community Centre for those suffering from substance-related disorders who may also have underlying respiratory diseases.

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. \>18 (no upper age limit)
2. Inhalation (smoking) of tobacco, or cannabis, or cocaine, or opioids, or use of alcohol in the past 28 days
3. Possession of a personal mobile phone to arrange follow-up appointments

Exclusion Criteria:

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

Primary outcomes:
measure: A brief respiratory health screening questionnaire
timeFrame: Day 1 and Day 3-7
Secondary outcomes:
measure: Specialist nurse and psychology assistant delivered Lung Health Clinic
timeFrame: Week 1 to Week 6
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: South London & Maudsley NHS Trust
Study officials:
References: