Clinical trial NCT06008145: COPD Case Finding in Nottingham and District: C-FIND COPD a Pilot Study
Official title: COPD Case Finding in Nottingham and District: C-FIND COPD a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
Keywords: COPD
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Nottingham
First posted: 2023-08-23
Enrollment: 600
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The Targeted Lung Health Check (THLC) cohort are a population that are at high risk for COPD, a lung condition often caused by smoking. This same population will be invited to undertake breathing test in order to early diagnose COPD.

Brief summary: The Targeted Lung Health Check (TLHC) is currently being rolled out in many regions of the United Kingdom and has just started in Nottingham. The same cohort of people are also at high risk for Chronic Obstructive Pulmonary Disease (COPD), a lung condition often caused by smoking and leading to breathlessness and cough. This study aims to provide pilot evidence of the role of breathing tests in those who have had a Computerised Tomography (CT) scan, in order to early diagnose COPD. Currently, at diagnosis, many patients have lost 30-40% of lung function already, which is not reversible.

This study will use the Nottingham University Hospitals Trust Mobile Research Unit. The unit will follow the CT scanner route 2-3 weeks later, and people who have had a CT scan will be invited for breathing tests. Participants will also collect further information on potential treatment options for people diagnosed with COPD earlier -including smoking cessation, symptom management and general health advice (vaccinations, diet, activity and managing infections). There is also an optional blood test.

The study aims are to determine the uptake and acceptability of breathing tests in patients at high risk of COPD, and if a community based approach co-locating with TLHC can increase uptake.

A qualitative sub-study has been added to assess the opportunities or barriers for people being invited for a COPD diagnosis visit in the community. This sub-study will have a recruitment target of 20 participants. It will involve transcribed interviews. This will help determine the accessibility of the mobile research unit in use for this study.

Detailed description: Ever smokers, aged between 55 to 74 years are invited for a telephone risk assessment. Those who are high risk (based on validated lung cancer risk scores, which incorporate a number of variables, including age and smoking intensity) are then sequentially invited for a CT scan in a certain locality of Nottingham as part of the TLHC. As the programme is introduced the number of invites per month will increase from 500 to 1800. It is anticipated that 40 to 45% of those will take up the invite and have a CT scan. At the time of their CT scan all smokers will be offered smoking cessation.

The clinical pathway incorporates that the CT scans will be reported by Heart Lung Health , with responsible clinician - Dr O'Dowd. Patients identified as having cancer or high likelihood will be approached and commenced on a cancer diagnostic pathway. This study addresses people who are not entering this pathway.

Two-three weeks after the CT scan, the clinical team will invite people to attend for a research study to assess lung health if they have symptoms of cough, breathlessness or 2 or more courses antibiotics in the last 15 months. No further reminder will be sent. The investigators will not excluding people with COPD already and will not turn away high-risk people who self-present even if not had a CT.

The invite will include mention of when the mobile unit is open and in their locality, what the visit consists of and that participants are free to come down at a convenient time. A telephone number and e-mail will be provided if somebody contacts the investigators and would prefer to be seen in a standard research unit - an appointment will be provided. The letter will remind participants that this cannot cover broader medical issues or emergencies, where usual clinical advice should be sought.

Following informed consent, the following will occur by trained clinical research practitioners and under the support of a research nurse.

* Questionnaires:

  * Symptom scores and information on tobacco smoking / other exposures, past medical history, medication
  * COPD Assessment Test (CAT) Quality of Life score
  * Medical Research Council (MRC) breathlessness score
  * Exacerbation frequency
  * EQ5D - Health Status
* Observations:

  * Oximetry for heart rate and oxygen saturations
  * Height
  * Weight
  * Blood pressure
* Postbronchodilator spirometry - salbutamol delivered by trained staff.
* Forced Oscillation Technique (FOT)- a non-clinically used breathing test but might have a role in early detection.
* Approach for future research and store research data obtained here / review medical records for future medicines.
* Invite to provide a blood sample and nasal swab for early markers of COPD - optional and currently of no clinical relevance.

Those with clinical evidence of COPD will be given information by a registered Health Care professional trained to do so on:

* COPD and what it is.
* Need for immunisations.
* General health education, self-management and tobacco cessation where indicated.
* Whether further review at the surgery is required.
* Clinical information will be fed back to primary care surgery and uploaded onto medical health records, such as SystemOne. The participant will have consented to this.

The investigators will seek feedback from participants and subsequently from the primary care clinicians.

A qualitative sub-study has been added to assess the opportunities or barriers for people being invited for a COPD diagnosis visit in the community. This sub-study will have a recruitment target of 20 participants. It will involve transcribed interviews. This will help determine the accessibility of the mobile research unit in use for this study.

Eligibility criteria: Inclusion Criteria:

* Smoking history - either compatible with TLHC (current or ex-smoker who are high risk based on lung cancer risk scores) or if self-presenting \>10 pack years (current or ex)
* Able to provide full informed consent.

Exclusion Criteria:

* People currently undergoing active investigation or treatment for cancer
* Unable to provide informed consent

Primary outcomes:
measure: Proportion of people who take up the invite to attend for a C-FIND visit.
timeFrame: 1.5 years
Secondary outcomes:
measure: Proportion diagnosed with COPD
timeFrame: 1.5 years
measure: CAT COPD Quality of Life Score
timeFrame: 1 day
measure: MRC breathlessness score
timeFrame: 1 day
measure: Exacerbation Frequency
timeFrame: 1 day
measure: EQ-5D-5L - Health Status
timeFrame: 1 day
measure: Oximetry for oxygen saturations
timeFrame: 1 day
measure: Height
timeFrame: 1 day
measure: Weight
timeFrame: 1 day
measure: BMI
timeFrame: 1 day
measure: Blood pressure diastolic
timeFrame: 1 day
measure: Post bronchodilator Spirometry
timeFrame: 1 day
measure: FOT-R (Resistance)
timeFrame: 1 day
measure: FOT-X (reactance)
timeFrame: 1 day
measure: FOT-AX (area of reactance)
timeFrame: 1 day
measure: FOT-Fres (resonant Frequency)
timeFrame: 1 day
measure: Blood pressure -systolic
timeFrame: 1 day
measure: What are the opportunities or barriers for people being invited for a COPD diagnosis visit in the community
timeFrame: From enrolment to the end of study
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: Nottinghamshire
Study officials:
affiliation: Nottingham University Hospitals NHS Trust
name: Charlotte Bolton, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: