Thinking of joining a study?

Register your interest

NCT05553951 | Active, not recruiting | Chronic Rhinosinusitis Without Nasal Polyps


Adherence in Global Airways
Sponsor:

Christiane Haase

Information provided by (Responsible Party):

Christiane Haase

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

Condition or disease

Chronic Rhinosinusitis Without Nasal Polyps

Asthma

Chronic Rhinosinusitis With Nasal Polyps

Chronic Rhinosinusitis (Diagnosis)

Intervention/treatment

Controlgroup

Intervention

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 90 participants
Masking : Quadruple
Primary Purpose : Treatment
Official Title : Adherence in Global Airways - Difference Between Structured and Systematic Nursing Supervison vs Usual Care
Actual Study Start Date : October 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025
Arm Intervention/treatment

Experimental: Interventions group

will receive systematic and structured nursing supervison about their adherence

Behavioral: Intervention

Placebo Comparator: Control group

Will receive usual care

Behavioral: Controlgroup

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Adherence in Global Airways

Location Details


Please Choose a site



Adherence in Global Airways

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Denmark,

Department of Otorhinolaryngology, Head and Neck Surgery & Audiology

Copenhagen, Denmark, 2100

Loading...