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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Department of Otorhinolaryngology, Head and Neck Surgery & Audiology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interventions group
will receive systematic and structured nursing supervison about their adherence
|
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
|
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
Time Frame: 4 months
|
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
Time Frame: 4 months
|
min.
0 point=no symptoms, max.
110 point=many symptoms.
|
4 months
|
|
miniAQLQ - Mini asthma quality of life questionnaire
Time Frame: 4 months
|
min.
1= all the time, max.
7= not at all
|
4 months
|
|
HADS - Hospital Anxiety and Depression Scale
Time Frame: 4 months
|
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)
Time Frame: 4 months
|
There is no minimum or maximum yet
|
4 months
|
|
ACT - Asthma Control Test
Time Frame: 4 months
|
min. 5 (poor control of asthma), max. 25 (complete control of asthma),
|
4 months
|
|
ACQ-7 - Asthma Control Questionnaire
Time Frame: 4 months
|
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
Time Frame: 4 months
|
min=0 point= normal sleep, max.
24 point= severe sleepiness.
|
4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-ENT-2- adherence
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.