Proof of Concept of Remote Management of Chronic Inflammatory Airway Diseases for Patient Empowerment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 136
- 主要终点
- Trial 1: Measuring the difference of FEV1 (%) between remotely use of a portable spirometer and the clinical standard spirometer
研究概览
简要总结
Chronic rhinosinusitis (CRS) is a multifactorial disease characterized by persistent symptomatic inflammation of the mucosa of the nose and paranasal sinuses, with (CRSwNP) or without (CRSsNP) the presence of nasal polyps. It affects 5 to 12% of the general population. CRS is often associated with asthma, which has a prevalence of 4% in the general population, reaching 30%-70% among patients with CRS. The current standard clinical evaluation of patients for both diseases has two main components: a subjective one (self-assessment provided by the patient), based mainly on the PROMs (Patient-Reported Outcome Measures) questionnaire, and an objective one (formulated by the clinician). Questionnaires present accuracy and response rate problems that have been investigated in the literature, finding that short questionnaires, incentives, personalization of questionnaires as well as repeat sending strategies or telephone reminders have a beneficial impact on the quantity and quality of responses. Today there are many new channels provided by technology. Among them, AI chatbots have been used in a variety of healthcare domains such as medical consultations, disease diagnosis, mental health support and, more recently, risk communications for the COVID-19 pandemic, and can offer a better way to collect questionnaires. At the same time, the recent technical solution of new non-invasive techniques for RFID radio frequency identification devices allows subjective reports to be accompanied with objective reports.
The PRECISION project aims to evaluate systems for home monitoring of chronic rhinosinusitis (CRS) and asthma, two highly prevalent chronic diseases. The frequent association between the two pathological conditions is a further argument in support of the rationality of a common approach.
As regards the collection of PROMs, three acquisition channels will be compared: i) AI Chatbots; ii) PhoneBot; iii) Mobile application. Data will be analyzed in relation to patient profiles to define the quality and quality of response.
Regarding objective evaluation, the project will investigate the efficiency of objective remote airflow measurements for both upper (CRS) and lower (asthma) airways using dedicated non-invasive systems based on RFID technology.
详细描述
The primary objective of the study is to create a Proof of Concept for the remote acquisition of subjective/objective data for patients with Asthma and CRS. In the current standard clinical assessment of patients with chronic diseases such as asthma and CRS there are two main components, one subjective (provided by the patient) and one objective (provided by the doctor). In particular, subjective data are acquired via standardized PROMs (such as SNOT-22 for CRS and ACT for asthma). The collection of objective data is obtained through clinical evaluations, such as endoscopic evaluation, olfactometry, radiological evaluation (with the definition of Lund-Mackey score), measurement of nasal flow (usually through PNIF or rhinomanometry), cytology, blood tests (in particular eosinophil count and IgE), FeNO (fractionated exhaled nitric oxide). Both types of data are needed simultaneously for the correct treatment and follow-up of the disease and, above all, the quality of the measurements is crucial.
The primary objective of the project is to quantify how much the patient's experience in managing part of their illness remotely improves compared to a hospital visit.
This will be quantitatively assessed through the administration of "PREMs" (Patient-Reported Experience Measures) questionnaires. In particular, in accordance with the state of the art, the investigators will evaluate patient satisfaction based on two questionnaires:
- CSQ8 (Client Satisfaction Questionnaire): provides a quantitative evaluation of the treatment
- PSSUQ (Post-Study System Usability Questionnaire): provides a quantitative assessment of the appropriateness of the technology used Finally, the investigastors will evaluate patients' satisfaction in being followed partly from home through an ad-hoc questionnaire.
Secondary objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •≥ 18 years
- •affected by chronic rhino sinusitis and/or asthma
- •not diagnosed with head and neck or lung cancer
- •no cardiovascular or metabolic uncontrolled diseases
- •if woman, not pregnant or breastfeeding
- •able to understand and sign the informed consent and to perform procedures required by the protocol
排除标准
- •< 18 years
- •affected by cancer or uncontrolled diseases
- •pregnant or breastfeeding women
- •uncompleted clinical history data
- •unable to sign the informed consent or to perform procedures required by the protocol
结局指标
主要结局
Trial 1: Measuring the difference of FEV1 (%) between remotely use of a portable spirometer and the clinical standard spirometer
时间窗: 6 months
The difference in terms of FEV1 (%) values between the experimental group, which depends on remote self-patient values obtained by a portable spirometer, and the control group, which depends on a clinical standard spirometer, will be measured.
Trial 1: Measuring patient satisfaction through PREMs (CSQ-8) scores assessment.
时间窗: 6 months
The evaluation will be done through standardized state-of-the-art PREMs ("Client Satisfaction Questionnaire", CSQ-8) scores and interviews. The unit of measure will be a pure number between 1 and 4 of the average CSQ-8 score. The satisfaction using (CSQ-8) between two groups will be measured.
Trial 1: Measuring rate of remotely completion of filling PROMs
时间窗: 6 months
Rate of remote completion of PROMs (specifically SNOT22 for CRS and ACT for asthma) will be measured.
.Measuring the quality of the answers given to the Asthma Control Test (ACT) submitted through phonebot, instant messaging, and dedicated Apps.
时间窗: 6 months
The Asthma Control Test (ACT) will be given to the participants as a patient-reported outcome measure (PROM), which is a questionnaire with 5 items assessing asthma symptoms (daytime and nocturnal), use of rescue medications, and the effect of asthma on daily functioning. The ACT survey will be provided using any of the phonebot, instant messaging, and dedicated Apps. For each technological channel (phonebot, instant messaging, and dedicated Apps), researchers will measure the quality of the answers using two methodologies taken from crowdsourcing, which are gold/repeated questions to measure self-consistency and meta-data analysis to spot random answers.
Trial 1: Evaluating the difference of PEF (L/sec) measurements between remotely use of a portable spirometer and the clinical standard spirometer
时间窗: 6 months
The difference in terms of PEF (L/sec) values between the experimental group, which depends on remote self-patient values obtained by a portable spirometer, and the control group, which depends on a clinical standard spirometer, will be measured.
Trial 3: Evaluating the difference of PEF measurements between Mobile Health Devices with the standard of care.
时间窗: Months 3 to 18
The difference in terms of values of PEF (l/sec) will be measured between two remote measurement tools, a portable spirometer, and an RFID-based solution, with the standardized ones used in ambulatory practice will be compared.
Trial 3: Evaluating the difference of PNIF measurements between Mobile Health Devices with the standard of care.
时间窗: Months 3 to 18
The difference in terms of values of PNIF (l/min) will be measured between two remote measurement tools, a portable spirometer, and an RFID-based solution, with the standardized ones used in ambulatory practice will be compared.
.Measuring the quality of the answers given to the Sino-Nasal Outcome Test-22 (SNOT22) submitted through phonebot, instant messaging, and dedicated Apps.
时间窗: 6 months
The Sino-Nasal Outcome Test-22 (SNOT22) will be given to the participants as a patient-reported outcome measure (PROM) to find out how bad their CRS symptoms are, which include both classic nasal symptoms and extranasal symptoms like trouble sleeping, ear/facial pain, and mood changes, all of which have been linked to allergic rhinitis. The SNOT22 questionnaire will be provided using any of the phonebot, instant messaging, and dedicated Apps. For each technological channel (phonebot, instant messaging, and dedicated Apps), researchers will measure the quality of the answers using two methodologies taken from crowdsourcing, which are gold/repeated questions to measure self-consistency and meta-data analysis to spot random answers.
Trial 2: Measuring best channel of filling PROMs submitted through different channels.
时间窗: 6 months
PROMs (SNOT22 and ACT) will be provided to the patients using different channels: Phonebot, Instant Messaging, and dedicated Apps. For each channel investigators will measure the best channel according to the technological profile of the patient, measured by "Client Satisfaction Questionnaire" (CSQ-8) and interviews.
Trial 2: Measuring the quality of the answers of filling PROMs submitted through different channels.
时间窗: 6 months
PROMs (SNOT22 and ACT) will be provided to the patients using different channels: Phonebot, Instant Messaging, and dedicated Apps. For each channel investigators will measure the quality of the answers using two methodologies taken from crowdsourcing which are gold/repeated questions to measure self-consistency, meta-data analysis to spot random answering.
Trial 2: Measuring the drop-off rate of filling PROMs submitted through different channels.
时间窗: 6 months
PROMs (SNOT22 and ACT) will be provided to the patients using different channels: Phonebot, Instant Messaging, and dedicated Apps. For each channel investigators will measure drop-off rate (ratio).
Trial 3: Evaluating the difference of FEV1 measurements between Mobile Health Devices with the standard of care.
时间窗: Months 3 to 18
The difference in terms of values of FEV1 (%) will be measured between two remote measurement tools, a portable spirometer, and an RFID-based solution, with the standardized ones used in ambulatory practice will be compared.
次要结局
未报告次要终点
研究者
Prof. Francesco Bussu
Professor
Azienda Ospedaliero Universitaria di Sassari