Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
NCT Number: NCT06008145
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.
This study is active but is not currently recruiting participants.
40 year and older
All sexes
Observational
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
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.
Those with clinical evidence of COPD will be given information by a registered Health Care professional trained to do so on:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1.5 years
0-100%
Time frame: 1.5 years
0-100%
Time frame: 1 day
Questionnaire. Wellbeing and daily life questions, scored 0-40 points, lower better
Time frame: 1 day
Questionnaire, self reported breathlessness grade 1-5, lower better
Time frame: 1 day
0-12/year
Time frame: 1 day
Questionnaire. Self reported health scale 0-100. Greater better
Time frame: 1 day
75-100% Oxygen saturation
Time frame: 1 day
Participant height in metres - range 1.2-2.0m
Time frame: 1 day
participant weight in Kg - range 35-180Kg
Time frame: 1 day
12-60g/m2
Time frame: 1 day
40-120mmHg
Time frame: 1 day
Forced Expired Volume (FEV)% - range 10-140% predicted
Time frame: 1 day
cmH2O.s/l
Time frame: 1 day
cmH2O.s/l
Time frame: 1 day
cmH2O/L
Time frame: 1 day
Hz
Time frame: 1 day
75-230mmHg
Time frame: From enrolment to the end of study
To assess the barriers and opportunities presented by the use of the mobile research unit
Nottingham University Hospitals NHS Trust
Other
Acronym: C-FIND
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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