COPD Case Finding In Nottingham and District: C-FIND COPD A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 568
- 试验地点
- 1
- 主要终点
- Proportion of people who take up the invite to attend for a C-FIND visit.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •People currently undergoing active investigation or treatment for cancer
- •Unable to provide informed consent
结局指标
主要结局
Proportion of people who take up the invite to attend for a C-FIND visit.
时间窗: 1.5 years
0-100%
次要结局
- FOT-Fres (resonant Frequency)(1 day)
- Blood pressure -systolic(1 day)
- FOT-AX (area of reactance)(1 day)
- Proportion diagnosed with COPD(1.5 years)
- CAT COPD Quality of Life Score(1 day)
- MRC breathlessness score(1 day)
- Exacerbation Frequency(1 day)
- EQ-5D-5L - Health Status(1 day)
- Oximetry for oxygen saturations(1 day)
- Height(1 day)
- Weight(1 day)
- BMI(1 day)
- Blood pressure diastolic(1 day)
- Post bronchodilator Spirometry(1 day)
- FOT-R (Resistance)(1 day)
- FOT-X (reactance)(1 day)
- What are the opportunities or barriers for people being invited for a COPD diagnosis visit in the community(From enrolment to the end of study)