Clinical trial NCT05553951: Adherence in Global Airways
Official title: Adherence in Global Airways - Difference Between Structured and Systematic Nursing Supervison vs Usual Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Rhinosinusitis Without Nasal Polyps
Asthma
Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis (Diagnosis)
Keywords: Adherence
Nurse
Global airways
Astma
Chronic Rhinosinusitis with Nasal Polyps
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: MARS-5 L/N - Medication adherence report scale both for upper and lower airways
timeFrame: 4 months
Secondary outcomes:
measure: SNOT-22 - The Sino-Nasal Outcome Test 22
timeFrame: 4 months
measure: miniAQLQ - Mini asthma quality of life questionnaire
timeFrame: 4 months
measure: HADS - Hospital Anxiety and Depression Scale
timeFrame: 4 months
measure: STARR-15 ) Standard test for asthma, rhinitis and chronic rhinosinusitis (15 questions)
timeFrame: 4 months
measure: ACT - Asthma Control Test
timeFrame: 4 months
measure: ACQ-7 - Asthma Control Questionnaire
timeFrame: 4 months
measure: ESS - EPWORTH SLEEPINESS SCALE
timeFrame: 4 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Otorhinolaryngology, Head and Neck Surgery & Audiology
Study officials:
affiliation: Rigshospitalet, Denmark
name: Vibeke P Backer
role: STUDY_CHAIR
References: