Adherence in Global Airways

NCT05553951 | Unknown

• 1 other identifier: 2022-ENT-2- adherence
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• SNOT-22 - The Sino-Nasal Outcome Test 22

  4 months

• miniAQLQ - Mini asthma quality of life questionnaire

  4 months

• HADS - Hospital Anxiety and Depression Scale

  4 months

• STARR-15 ) Standard test for asthma, rhinitis and chronic rhinosinusitis (15 questions)

  4 months

• ACT - Asthma Control Test

  4 months

Study Arms (2)

Interventions group

EXPERIMENTAL

will receive systematic and structured nursing supervison about their adherence

Behavioral: Intervention

Control group

PLACEBO COMPARATOR

Will receive usual care

Behavioral: Controlgroup

Interventions

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.

Control group

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.

Interventions group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christiane Haase: lead

Study Sites (1)

Department of Otorhinolaryngology, Head and Neck Surgery & Audiology

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Asthma; Disease

Interventions

Methods

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Vibeke P Backer

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical nurse specialist and Phd-student

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 26, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

DK (1)