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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
The control group and intervention group will receive daily text message reminders twice a week to take their medications and to rinse their nose.
Patients in the intervention group will receive systematic and structured nursing guidance regarding their adherence, which includes proper use of nasal irrigation once or twice daily, nasal steroid/drops, use of inhaled medications, follow-up of smoking status. The intervention group will receive guidance videos which have been prepared prior to the study and will be standard for the intervention group. Guidance videos will cover the correct use of nasal irrigation, inhalation steroid, and nasal steroid/drops.
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology
Copenhagen, Denmark
MARS-5 L/N - Medication adherence report scale both for upper and lower airways
Min. 0 point= non adherent, max. 25 point=adherent
Time frame: 4 months
SNOT-22 - The Sino-Nasal Outcome Test 22
min. 0 point=no symptoms, max. 110 point=many symptoms.
Time frame: 4 months
miniAQLQ - Mini asthma quality of life questionnaire
min. 1= all the time, max. 7= not at all
Time frame: 4 months
HADS - Hospital Anxiety and Depression Scale
Min 0 point=no risk, Max 21 point=high risk. It applies both anxiety and depression
Time frame: 4 months
STARR-15 ) Standard test for asthma, rhinitis and chronic rhinosinusitis (15 questions)
There is no minimum or maximum yet
Time frame: 4 months
ACT - Asthma Control Test
min. 5 (poor control of asthma), max. 25 (complete control of asthma),
Time frame: 4 months
ACQ-7 - Asthma Control Questionnaire
min. 0 point= complete control of asthma, max 6 point= poor control of asthma Rigtig dårlig kontrol er \> 1.5
Time frame: 4 months
ESS - EPWORTH SLEEPINESS SCALE
min=0 point= normal sleep, max. 24 point= severe sleepiness.
Time frame: 4 months
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