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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventions group | Experimental | will receive systematic and structured nursing supervison about their adherence |
|
| Control group | Placebo Comparator | Will receive usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Controlgroup | Behavioral | The control group and intervention group will receive daily text message reminders twice a week to take their medications and to rinse their nose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MARS-5 L/N - Medication adherence report scale both for upper and lower airways | Min. 0 point= non adherent, max. 25 point=adherent | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| SNOT-22 - The Sino-Nasal Outcome Test 22 | min. 0 point=no symptoms, max. 110 point=many symptoms. | 4 months |
| miniAQLQ - Mini asthma quality of life questionnaire | min. 1= all the time, max. 7= not at all |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vibeke P Backer | Rigshospitalet, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otorhinolaryngology, Head and Neck Surgery & Audiology | Copenhagen | 2100 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 6, 2022 | Sep 21, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Intervention | Behavioral | 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. |
|
| 4 months |
| HADS - Hospital Anxiety and Depression Scale | Min 0 point=no risk, Max 21 point=high risk. It applies both anxiety and depression | 4 months |
| STARR-15 ) Standard test for asthma, rhinitis and chronic rhinosinusitis (15 questions) | There is no minimum or maximum yet | 4 months |
| ACT - Asthma Control Test | min. 5 (poor control of asthma), max. 25 (complete control of asthma), | 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 | 4 months |
| ESS - EPWORTH SLEEPINESS SCALE | min=0 point= normal sleep, max. 24 point= severe sleepiness. | 4 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |