A Structured Health Assessment in Frequent COPD Exacerbators: To Optimise Management, Identify Comorbidities and Prevent Oral Corticosteroid Related Harm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Cumulative dose of oral prednisolone over 12-months*. * excluding short courses of prednisolone prescribed for conditions not related to airway exacerbations (e.g. anaphylaxis, inflammatory bowel disease, cutaneous skin disorders).
研究概览
简要总结
Background:
Chronic obstructive pulmonary disease (COPD) is a serious lung condition and the third leading cause of death worldwide. People with COPD have sudden and distressing flare-ups (exacerbations). These can be triggered by infections or occur without a clear cause. Flare-ups often lead to hospital admission, can cause a lasting health decline, increase the risk of dying and are strongly liked to lower income.
Sometimes, people are wrongly diagnosed with COPD, when they have a different health issue. Other diseases (like heart conditions) are common in people with COPD, and share similar symptoms. These have often not been diagnosed and worsening of these conditions can look like a flare-up of COPD, leading to incorrect treatment. Additionally, many people with COPD have not been offered appropriate treatments that would reduce their flare-up frequency.
COPD flare-ups are treated with steroid tablets (prednisolone), and sometimes antibiotics. Frequent use of prednisolone causes side effects such as weight gain, bone thinning (osteoporosis) and diabetes. Reducing how often people with COPD have flare-ups can reduce these side effects.
The investigators aim to reduce COPD flare-ups and prevent harm from prednisolone by improving the treatment of COPD, while also checking for other health conditions.
The goal:
In people with COPD, who take prednisolone for flare-ups (three of more times a year), the investigators want to see if a thorough assessment (that focuses on the treatment of COPD and diagnosis of other common health problems), reduces the number of flare-ups that need prednisolone over the next year.
Design:
Participants will attend a half-day hospital visit for a thorough check-up (a mini-MOT). The assessment includes a review by a doctor, questionnaires, blood tests, breathing tests, a scan of the chest (CT), and investigations on the heart. The investigators will make sure participants receive the correct treatment for their COPD.
The assessment will focus on three areas: lung health, identifying and treating important health issues outside of the lungs (that may be contributing or causing symptoms similar to COPD) and supporting changes in behaviours that can improve lung health. These factors (whether in the lungs, body or related to lifestyle) are known as treatable traits.
The investigators will also review participants prednisolone use and check for health problems that may have been caused by it. At the end of the assessment participants will be given a personalised treatment plan.
Participants will be followed up for 12 months, at 3 month intervals. During this time they will collect information on the number of emergency hospital visits, serious heart-related events, steroid tablets taken for COPD flare-ups and any deaths. They will ask participants to complete short questionnaires about their health and wellbeing.
Who provided advise on this study :
Preventing COPD flare-ups is a top priority, identified by The James Lind Alliance (a national research priority setting partnership). This study was reviewed by the Northumbria Lung Research Patient Advisory Group (people living with COPD). They felt the study was well-designed and likely to make a meaningful difference. People with experience in research and COPD also gave feedback, and changes were made, such as reducing travel requirements, based on their views. The research team has successfully completed studies that have led to real improvement in COPD care, and are committed to ensuring this study has a similar positive impact.
Sharing results:
At the end of the study results will be shared with the public, study participants, healthcare workers, commissioners and guideline advisory groups. The findings will be shared on online platforms, present them at national/international conferences, and published in medical journals. The aim is to ensure findings improve clinical practice, policies and guidelines.
详细描述
Background:
Chronic obstructive pulmonary disease (COPD) is a serious lung condition and the third most common cause of death worldwide. In England, COPD causes 121,129 hospital stays and 20,000 deaths each year. Despite how common and serious it is, only 2% of public research funding targets lung diseases like COPD.
People with COPD have sudden and distressing flare-ups (exacerbations). These can be triggered by infections or occur without a clear cause. Exacerbations are serious, they often lead to hospital admission, can cause a lasting health decline, increase the risk of dying and are strongly liked to lower income.
Frequent exacerbators is a term used to describe people who experience 2 or more COPD exacerbations each year, and super-exacerbators have 3 or more exacerbations each year. COPD flare-ups are treated with steroid tablets (prednisolone) and sometimes antibiotics. Steroid tablets help recovery but frequent use causes side effects such as weight gain, bone thinning (osteoporosis) and diabetes. People with COPD receive steroids very frequently; a third of all UK steroid prescriptions are for people with COPD, and this number is increasing.
Sometimes, people are wrongly diagnosed with COPD, when they have a different health issue. Other diseases (like heart conditions) are common in people with COPD, and share similar symptoms. These have often not been diagnosed and worsening of these conditions can look like a flare-up of COPD, leading to incorrect treatment. Additionally, many people with COPD have not been offered appropriate treatments that would reduce their flare-up frequency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD diagnosis documented in primary care records for at least 12 months.
- •Age 35 years or older
- •3 or more prednisolone prescriptions in the past 12-months for ECOPD*
- •Capacity to give informed consent
- •Clinically stable at study entry (≥4 weeks following last ECOPD or other significant acute illness) * each prednisolone course separated by a minimum of 14 days from completion of the previous course.
排除标准
- •Maintenance OCS use currently or within the past 12 months *
- •Anticipated inability to comply with the protocol
- •Illness limiting life expectancy to less than 12 months (other than COPD)
- •Lung transplant
- •Domiciliary non-invasive ventilation *defined as ≥10mg daily for ≥ 6 weeks
研究组 & 干预措施
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: DXA (Radiation)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: Education (Behavioral)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: Sputum sample (Diagnostic Test)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: Venepuncture (Diagnostic Test)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: Lung function test (Diagnostic Test)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: Medical history and physical examination (Diagnostic Test)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: Blood pressure (Diagnostic Test)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: BMI (Diagnostic Test)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: HRCT of chest (Radiation)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: ECG (Diagnostic Test)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: Echo (Diagnostic Test)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: Subject Questionnaires (Diagnostic Test)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: Research Questionnaires (Diagnostic Test)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: Influenza Vaccines (Biological)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: Pneumococcal Vaccine (Biological)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: RSV F vaccine (0.5mL injection) (Biological)
Structured Health Assessment
Structured Health Assessment
- Confirm (or exclude) the COPD diagnosis and measure study outcomes
- Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits
- Perform a comprehensive multi-morbidity assessment
- Deliver targeted educational interventions
干预措施: Oxygen saturation (+/- ABG) (Diagnostic Test)
结局指标
主要结局
Cumulative dose of oral prednisolone over 12-months*. * excluding short courses of prednisolone prescribed for conditions not related to airway exacerbations (e.g. anaphylaxis, inflammatory bowel disease, cutaneous skin disorders).
时间窗: 12 months (commencing 8 weeks after structured assessment complete). Measured at 5, 8, 11 and 14 months from enrolment.
次要结局
- Number of severe ECOPD (unplanned hospital admission) per annum.(14 months from enrolment. Measured at 5, 8, 11 and 14 months)
- Number of Emergency department visits per annum: all-cause and respiratory.(14 months from enrolment. Measured at 5, 8, 11 and 14 months)
- Number of new treatments initiated (per participant), both overall and by specific therapy (class/ type), started as result of the multidimensional assessment(Last subject, 8 week review)
- Time to death (all cause and respiratory).(14 months from enrolment. Measured at 5, 8, 11 and 14 months)
- Number of moderate and severe exacerbations(14 months from enrolment. Measured at 5, 8, 11 and 14 months)
- Proportion of participants with confirmed COPD (based on spirometry and clinical assessment).(From enrolment to end of structured assessment (week 1))
- Distribution of COPD by severity, endotype and phenotype.(From enrolment to end of structured assessment (week 1))
- Proportion of participants receiving new or adjusted COPD-specific treatments.(From enrolment to review of investigation outcomes and adherence (week 8))
- Proportion of participants with each comorbidity, stratified by whether the condition was previously recognised or newly identified.(From enrolment to review of investigation outcomes and adherence (week 8))
- Total cumulative dose of oral prednisolone (per year) for the past 10 years (or since COPD diagnosis if more resent).(From enrolment to end of structured assessment (week 1))
- Number of oral prednisolone courses (per year) over the past 10 years (or since COPD diagnosis if more resent).(From enrolment to end of structured assessment (week 1))
- Covariates independently associated with cumulative corticosteroid dose.(From visit 2: 8 weeks to end of study (14 months))
- Mortality: all cause and respiratory.(14 months from enrolment. Measured at 5, 8, 11 and 14 months.)
- Non fatal and fatal major adverse cardiovascular events(14 months from enrolment. Measured at 5, 8, 11 and 14 months)
- Time to first cardiopulmonary event.(14 months from enrolment. Measured at 5, 8, 11 and 14 months)
- 12. Mean change in St George's Respiratory Questionnaire- COPD(14 months from enrolment. Measured at week 1, 5 months, 8 months, 11 months and 14 months.)
- 12. Mean change in quality of life (EQ-5D-5L)(14 months from enrolment. Measured at week 1, 5 months, 8 months, 11 months and 14 months.)
- 12. Mean change in quality of life (EQ VAS)(14 months from enrolment. Measured at week 1, 5 months, 8 months, 11 months and 14 months.)
- Mean change in anxiety and depression (Hospital Anxiety and Depression Scale)(14 months from enrolment. Measured at week 1 and 14 months.)
- Change in patient activation (Partners in health scale)(14 months from enrolment. Measured at week 1 and 14 months.)
- Inpatient hospital bed days per annum: all cause and respiratory.(14 months from enrolment. Measured at 5, 8, 11 and 14 months)
- Non fatal major adverse cardiovascular events per annum (nonfatal stroke, nonfatal myocardial infarction).(14 months from enrolment. Measured at 5, 8, 11 and 14 months)
- Total cumulative dose of oral prednisolone per year over the past 10 years (or since COPD diagnosis if more resent).(From enrolment to end of structured assessment (week 1))