ISRCTN10567920进行中（未招募）未知
A pragmatic, cluster randomized trial evaluating the impact of an enhanced adherence package (dual bronchodilator + add-on + app) on time to treatment failure and other clinical outcomes in exacerbating COPD patients with poor adherence to mono or dual therapy over one year
Observational and Pragmatic Research International Ltd0 个研究点目标入组 1,312 人开始时间: 2019年7月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,312
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34079422/ (added 04/06/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 06/09/2023:
- •For a practice to be eligible for participation, the following criteria should be met:
- •1. General practice in the United Kingdom (England, Scotland, Wales, Northern Ireland) participating in Optimum Patient Care services that support chronic disease review and provide high-quality respiratory data
- •2. Willing to use advanced technology as part of clinical practice
- •3. At least 8 patients suitable for adherence technology
- •4. Actively prescribing Ultibro® Breezehaler® as a routine clinical care option; (i.e. inhaler compatible with the add-on technology)
- •Patients suitable for adherence technology support:
- •1. Aged =40 years
- •2. Ever-smoker
- •3. On the COPD register of participating practices
- •4. Coded COPD diagnosis and FEV1/FVC ever recorded <0.7
- •5. At least 2 moderate/severe COPD exacerbations in the last 24 months (or prior to March 2020, if poorer)
- •6. Total adherence to current mono/dual therapy of =50% based on refill Rx data or a clinical EHR code for poor adherence in the last 12 months (or prior to March 2020, if poorer)
- •Previous inclusion criteria:
- •For a practice to be eligible for participation, the following criteria should be met:
- •1. Willing to receive OPC clinical audit and quality improvement services, including IT access for secure software installation and de-identified data extraction
- •2. Willing to use adherence technology as part of clinical practice
- •3. At least 16 patients suitable for adherence technology support (see below)
- •4. A clinician (doctor, nurse, pharmacist, etc) willing to act as a practice lead
- •5. Prescribing or able to prescribe Ultibro® Breezehaler® as a routine clinical care option i.e. inhaler compatible with the add-on technology
- •Patients suitable for adherence technology support:
- •1. Confirmed COPD diagnosis
- •2. Smoking history
- •3. At least 2 COPD exacerbations in the last 24 months
- •4. Poor adherence to single/dual COPD therapy – Total adherence to current mono/dual therapy of =50% based on refill Rx data in the last 12 months
排除标准
- •Current exclusion criteria as of 06/09/2023:
- •Practice exclusion criteria:
- •1. General practice not prescribing Ultibro® as part of routine clinical care to patients with COPD
- •2. General practices hosting or affected by research, or other aspects of care, which might significantly influence the practice-wide implementation
- •Patient exclusion criteria:
- •1. Patients with a consent refusal code indicating opt-out of data used for research
- •2. Patients not deemed clinically appropriate for the therapy which is technology-compatible
- •3. Patients on triple therapy (ICS/LABA/LAMA)
- •4. Read code for asthma (excluding ‘asthma resolved’ read codes)
- •5. Blood eosinophil count >300 cells/µl if blood count available in the last 12 months
- •6. Unable to use technology (e.g. not having/able to use a smartphone compatible with the technology, not having reliable Internet access)
- •Previous exclusion criteria:
- •GP Practice who cannot prescribe Ultibro breezhaler or currently do not prescribe Ultibro breezhaler
研究者
相似试验
已完成
不适用
Evaluation of the impact of Community-Based Sociotherapy on social dignity among beneficiaries dealing with the consequences of genocide in RwandaMental health and psychosocial wellbeingMental and Behavioural DisordersISRCTN11199072niversity of Rwanda1,200
已完成
不适用
Pilot testing of a new approach to improving the prescribing of many drugs for older people who live in their own home and are cared for by general practitionersMultiple medications (polypharmacy) in older adultsISRCTN41009897Queen's University Belfast68
已完成
不适用
Surgical Wounds Healing By Secondary Intention - 2ISRCTN26277546Hull University Teaching Hospital NHS Trust686
进行中（未招募）
Unknown
Rehabkompassen® – A digital structured follow-up tool for facilitating patient-tailored rehabilitation in persons after strokeNervous System DiseasesStrokeISRCTN63166587Region Västerbotten1,106
已完成
不适用
Health professional Administered Brief Insomnia Therapy (HABIT) trialMental and Behavioural DisordersDisorders of initiating and maintaining sleep [insomnias]InsomniaISRCTN42499563niversity of Oxford642