Christiane Haase
Christiane Haase
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
Chronic Rhinosinusitis Without Nasal Polyps
Asthma
Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis (Diagnosis)
Controlgroup
Intervention
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 90 participants |
Masking : | Quadruple |
Primary Purpose : | Treatment |
Official Title : | Adherence in Global Airways - Difference Between Structured and Systematic Nursing Supervison vs Usual Care |
Actual Study Start Date : | October 1, 2022 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | December 31, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Interventions group will receive systematic and structured nursing supervison about their adherence |
Behavioral: Intervention |
Placebo Comparator: Control group Will receive usual care |
Behavioral: Controlgroup |
Ages Eligible for Study: | 18 Years to 100 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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Not yet recruiting
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology
Copenhagen, Denmark, 2100