Adherence in Global Airways (AIR2022)

Christiane Haase

Status: Active, not recruiting

Conditions: Asthma; Chronic Rhinosinusitis With Nasal Polyps; Chronic Rhinosinusitis Without Nasal Polyps; Chronic Rhinosinusitis (Diagnosis)

Treatments: Behavioral: Controlgroup; Behavioral: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05553951

2022-ENT-2- adherence

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Interventions group

Experimental group

Description:

will receive systematic and structured nursing supervison about their adherence

Treatment:

Behavioral: Intervention

Control group

Placebo Comparator group

Description:

Will receive usual care

Treatment:

Behavioral: Controlgroup