Development of the Drug and Alcohol Respiratory Health Test (DARHT)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Substance-Related Disorders; Pneumonia; Asthma; Obstructive Sleep Apnea; Lung Cancer; Tuberculosis; Bronchitis; COPD; Respiratory Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 260

Contacts and Locations

• Study Contact: Name: John Marsden, B.Sc., M.Sc., PhD, PgDiP CBT; Phone Number: +44 02078365454; Email: john.marsden@kcl.ac.uk
• Study Contact Backup: Name: Francesca Small, Msc; Phone Number: + 44 020 3228 1500; Email: francesca.a.small@kcl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, BR3 3BX
    • South London & Maudsley NHS Trust
    • Contact: Mike Kelleher, MD; Phone Number: 44 020 3228 1500; Email: mike.kelleher@slam.nhs.uk
    • Contact: John Marsden, B.Sc., M.Sc., PhD, PgDiP CBT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Addictions Community Centre for those suffering from substance-related disorders who may also have underlying respiratory diseases.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A brief respiratory health screening questionnaire	To investigate the accuracy of a brief respiratory health screening questionnaire in highlighting respiratory health symptoms in participants with Substance Use Disorders.	Day 1 and Day 3-7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specialist nurse and psychology assistant delivered Lung Health Clinic	Evaluate the effectiveness of a specialist nurse and psychology assistant delivered by the Lung Health Clinic in improving respiratory health referrals, airway medication updates and adherence, service satisfaction, and quality of life.	Week 1 to Week 6

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: South London and Maudsley NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): November 11, 2025
• Study Completion (Estimated): November 11, 2025

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Respiratory Tract Infections; Infections; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Chemically-Induced Disorders; Sleep Wake Disorders; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Actinomycetales Infections; Mycobacterium Infections; Substance-Related Disorders; Sleep Apnea, Obstructive; Respiratory Tract Diseases; Tuberculosis; Respiration Disorders; Bronchitis
• Other Study ID Numbers: DARHT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No