The SENSOR Study: A Mixed-methods Study of SElf-management Checks to Predict exacerbatioNs of Pseudomonas Aeruginosa in Patients With Long-term reSpiratORy Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Exacerbation
研究概览
简要总结
The World Health Organisation predicts that lung disease will be the World's third largest killer in the future. This research project is looking to see whether the concept of a "home hospital" using the latest gadgets and iPad technology, can help patients stay well and out of hospital.
Portsmouth Hospitals Trust is collaborating with a Company based in the United Kingdom (UK) who has developed a test to predict when people with lung diseases, such as; asthma, COPD and bronchiectasis, who regularly have chest infections, are about to become poorly with another infection - a form of early warning system. The investigators hope that the test will eventually be able to be used by the patient at home daily, to help self-manage their condition. The test measures whether bacteria are present, in sputum, and in what quantity. This information can be used by the patient's healthcare team to consider providing treatment earlier, thus controlling the infection sooner and reducing the patient's symptoms so that patients can stay at home rather than being regularly admitted to hospital.
Part of this "early warning system" that has been developed by the UK Company includes the daily measurement of a number of indicators of health. These are usually only measured in hospital or by a General Practitioner, but new devices have been made that are simple enough for everyone to use at home.
The investigators will include 30 participants, with non-Cystic Fibrosis (CF) chronic respiratory conditions who will be asked to take daily measurements of their blood pressure, temperature, weight and how well their heart and lungs are working with easy-to-use devices. They will also measure their physically activity with an activity tracker and report their wellness and whether they have taken medication daily. Participants will also be asked to collect a sample of sputum and urine each morning. Taking the samples and measurements should only take between 5-15 minutes each day to carry out.
The sputum and urine will be tested at the hospital and will be recorded and analysed, so that the researchers can learn what happens well before a person with these conditions falls sick and needs hospitalisation.
详细描述
The purpose of this study is to see whether the concept of a "home hospital" using the latest gadgets and iPad technology, can help patients stay well and out of hospital.
This trial is a single centre, non-randomised, mixed methods study. A longitudinal cohort of patients and their carers (where appropriate) will be asked to collect physiological, biological and disease outcome data over a 6 month period. Both participants and the clinicians responsible for patient care and will have no access to the longitudinal data and this information will not be used to make clinical decisions. The laboratory samples will also be analysed in a blinded manner. These data will then be analysed to develop a model for predicting onset of exacerbations which can be built into a self-monitoring system.
Qualitative methods will be used to explore participant and carer experiences of using the technology and performing daily self-monitoring assessments. The expected duration of participant participation in the cohort will be six months, with an invitation to complete a self-administered questionnaire at baseline to inform a face to face semi-structured interview with patients with, or without carer joint participant at the end of the follow-up period (six months completion).
A total of 30 male and female patients, aged 18 and over will be recruited;
20 patients chronically infected with Pseudomonas Aeruginosa (PA):
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, aged 18 years or above.
- •Diagnosed with at least one (or a combination) of the following chronic respiratory conditions: asthma, COPD, non-CF bronchiectasis.
- •Previous positive bacterial culture for PA or HI.
- •Two or more exacerbations treated with antibiotics with the same pathogen within the last 12 months, one of which must have been within the last 6 months.
- •Has been exacerbation free for the previous 4 weeks.
- •Producing at least 1ml of sputum daily.
- •Must be capable of operating the self-monitoring devices and tablet-based IT system, or have a carer capable of undertaking the measurements and collection, storage and transport of samples.
- •Participant is willing and able to give informed consent for participation in the study.
排除标准
- •A suspected or confirmed diagnosis of Cystic Fibrosis
- •Any condition likely to limit participant survival or adherence during the study period in the judgement of the clinician, for example malignancy, cirrhosis of the liver.
- •Currently taking part in any other research study.
结局指标
主要结局
Exacerbation
时间窗: 6 months
An exacerbation will be defined as the initiation of antimicrobial therapy for respiratory symptoms either at home or on admission, with or without concomitant steroids or admission. For patients who are already on continuous antibiotics, an exacerbation will be defined as starting a course of different antibiotics due to increased symptoms, or an increase or dose or frequency.
次要结局
- Treatment Efficacy(6 months)