Adherence in Global Airways

Asthma Clinical Trial

— AIR2022  

Official title:

Adherence in Global Airways - Difference Between Structured and Systematic Nursing Supervison vs Usual Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05553951
• Other study ID #: 2022-ENT-2- adherence
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Asthma
• Chronic Rhinosinusitis (Diagnosis)
• Chronic Rhinosinusitis With Nasal Polyps
• Chronic Rhinosinusitis Without Nasal Polyps
• Nasal Polyps
• Polyps
• Sinusitis

Intervention

Behavioral:
• Controlgroup
The control group and intervention group will receive daily text message reminders twice a week to take their medications and to rinse their nose.
• Intervention
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.

Locations

Country	Name	City	State
Denmark	Department of Otorhinolaryngology, Head and Neck Surgery & Audiology	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Christiane Haase

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	SNOT-22 - The Sino-Nasal Outcome Test 22	min. 0 point=no symptoms, max. 110 point=many symptoms.	4 months
Secondary	miniAQLQ - Mini asthma quality of life questionnaire	min. 1= all the time, max. 7= not at all	4 months
Secondary	HADS - Hospital Anxiety and Depression Scale	Min 0 point=no risk, Max 21 point=high risk. It applies both anxiety and depression	4 months
Secondary	STARR-15 ) Standard test for asthma, rhinitis and chronic rhinosinusitis (15 questions)	There is no minimum or maximum yet	4 months
Secondary	ACT - Asthma Control Test	min. 5 (poor control of asthma), max. 25 (complete control of asthma),	4 months
Secondary	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
Secondary	ESS - EPWORTH SLEEPINESS SCALE	min=0 point= normal sleep, max. 24 point= severe sleepiness.	4 months