Adherence in Global Airways - Difference Between Structured and Systematic Nursing Supervison vs Usual Care
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- MARS-5 L/N - Medication adherence report scale both for upper and lower airways
研究概览
简要总结
There is a strong case for treating diseases of both the upper and lower airways (global airways) simultaneously because they share the same inflammatory mechanisms. About 9% have chronic sinusitis (CRS) and 4% of the Danish population are diagnosed with CRS with nasal polyps (CRSwNP)) and 7-10% have asthma. CRS has a multifactorial background, with CRSwNP characterized by Type 2 inflammation, and approximately 50% with Type 2 CRSwNP also have co-morbid asthma. Well-treated CRS has an impact on asthma control, and well-treated asthma has an impact on CRS.
Several studies show that patients with asthma have low adherence, but only a few if any of studies are available on adherence in CRS.
Aim:
To investigate the effect of systematic and structured nursing supervision in patients with CRSwNP and asthma primarily on adherence.
Hypothesis and research questions: Patients with respiratory diseases can improve their adherence to their non-medical and medical treatment for CRSwNP/CRS and asthma by systematic and structured nursing supervision compared to patients who receive usual care.
In a randomized clinical trial, we will investigate whether the level of adherence measured by the questionnaire MARS-5-N and MARS-5- L in patients with CRSwNP and asthma can be improved by 7 points after systematic and structured nursing guidance at baseline visit and controlled after four months - compared with those patients who have not received the above guidance.
Primary outcome: is change in adherence rate measured by the MARS-5-N/L questionnaire in patients with CRSwNP and asthma can be improved by 4 points after systematic and structured nursing guidance at the initial visit and controlled after four months - compared with patients who have not received the above guidance.
Inclusion Criteria:
Adherence to MARS- 5 L/N ≤35 at first visit, diagnosed with asthma (with/without allergic rhinitis) at initial visit, diagnosed with CRSwNP, able to use smartphone, ACQ ≥1.2 or ACT≤15 (partially uncontrolled asthma), >18 years of age, SNOT-22 score ≥35
Exclusion Criteria:
- Adherence to MARS-5- L/N >35 points at first visit,do not have smartphone, does not read/speak English, other illness requiring regular medication, pregnancy/pregnancy that started during the study, server psychological comorbidities
Questionnaires: Patients must answer the following questionnaires at baseline and at 4 months follow up ESS, SNOT-22, ACQ-7, ACT, MiniAqLq, HADS, STARR-15
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adherence to MARS- 5 L/N ≤35 at first visit
- •Diagnosed with asthma (with and without allergic rhinitis) at initial visit
- •Able to use smartphone
- •ACQ ≥1.2 or ACT≤15 (partially uncontrolled asthma)
- •Be over 18 years of age
- •SNOT-22 score ≥35
- •Diagnosed with CRSwNP
排除标准
- •Adherence to MARS-5- L/N >35 points at first visit
- •Do not have smartphone
- •Does not read or speak English
- •Other illness requiring regular medication
- •Pregnancy and pregnancy that started during the study time period
- •Servere psychological comorbidities
结局指标
主要结局
MARS-5 L/N - Medication adherence report scale both for upper and lower airways
时间窗: 4 months
Min. 0 point= non adherent, max. 25 point=adherent
次要结局
- STARR-15 ) Standard test for asthma, rhinitis and chronic rhinosinusitis (15 questions)(4 months)
- ESS - EPWORTH SLEEPINESS SCALE(4 months)
- SNOT-22 - The Sino-Nasal Outcome Test 22(4 months)
- HADS - Hospital Anxiety and Depression Scale(4 months)
- ACT - Asthma Control Test(4 months)
- ACQ-7 - Asthma Control Questionnaire(4 months)
- miniAQLQ - Mini asthma quality of life questionnaire(4 months)
研究者
Christiane Haase
Clinical nurse specialist and Phd-student
Rigshospitalet, Denmark