Adherence in Global Airways (AIR2022)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Asthma; Chronic Rhinosinusitis (Diagnosis); Chronic Rhinosinusitis With Nasal Polyps; Chronic Rhinosinusitis Without Nasal Polyps
• Intervention / Treatment: Behavioral: Intervention; Behavioral: Controlgroup

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Otorhinolaryngology, Head and Neck Surgery & Audiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventions group; will receive systematic and structured nursing supervison about their adherence	Behavioral: 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.
Placebo Comparator: Control group; Will receive usual care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Christiane Haase

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Nurse; Adherence; Chronic Rhinosinusitis with Nasal Polyps; Global airways; Astma
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Nasal Polyps; Polyps
• Other Study ID Numbers: 2022-ENT-2- adherence

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No