Adherence in Global Airways (AIR2022)
Primary Purpose
Chronic Rhinosinusitis Without Nasal Polyps, Asthma, Chronic Rhinosinusitis With Nasal Polyps
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Controlgroup
Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis Without Nasal Polyps focused on measuring Adherence, Nurse, Global airways, Astma, Chronic Rhinosinusitis with Nasal Polyps
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
Sites / Locations
- Department of Otorhinolaryngology, Head and Neck Surgery & Audiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Interventions group
Control group
Arm Description
will receive systematic and structured nursing supervison about their adherence
Will receive usual care
Outcomes
Primary Outcome Measures
MARS-5 L/N - Medication adherence report scale both for upper and lower airways
Min. 0 point= non adherent, max. 25 point=adherent
Secondary Outcome Measures
SNOT-22 - The Sino-Nasal Outcome Test 22
min. 0 point=no symptoms, max. 110 point=many symptoms.
miniAQLQ - Mini asthma quality of life questionnaire
min. 1= all the time, max. 7= not at all
HADS - Hospital Anxiety and Depression Scale
Min 0 point=no risk, Max 21 point=high risk. It applies both anxiety and depression
STARR-15 ) Standard test for asthma, rhinitis and chronic rhinosinusitis (15 questions)
There is no minimum or maximum yet
ACT - Asthma Control Test
min. 5 (poor control of asthma), max. 25 (complete control of asthma),
ACQ-7 - Asthma Control Questionnaire
min. 0 point= complete control of asthma, max 6 point= poor control of asthma Rigtig dårlig kontrol er > 1.5
ESS - EPWORTH SLEEPINESS SCALE
min=0 point= normal sleep, max. 24 point= severe sleepiness.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05553951
Brief Title
Adherence in Global Airways
Acronym
AIR2022
Official Title
Adherence in Global Airways - Difference Between Structured and Systematic Nursing Supervison vs Usual Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christiane Haase
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventions group
Arm Type
Experimental
Arm Description
will receive systematic and structured nursing supervison about their adherence
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Will receive usual care
Intervention Type
Behavioral
Intervention Name(s)
Controlgroup
Intervention Description
The control group and intervention group will receive daily text message reminders twice a week to take their medications and to rinse their nose.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
MARS-5 L/N - Medication adherence report scale both for upper and lower airways
Description
Min. 0 point= non adherent, max. 25 point=adherent
Time Frame
4 months
Secondary Outcome Measure Information:
Title
SNOT-22 - The Sino-Nasal Outcome Test 22
Description
min. 0 point=no symptoms, max. 110 point=many symptoms.
Time Frame
4 months
Title
miniAQLQ - Mini asthma quality of life questionnaire
Description
min. 1= all the time, max. 7= not at all
Time Frame
4 months
Title
HADS - Hospital Anxiety and Depression Scale
Description
Min 0 point=no risk, Max 21 point=high risk. It applies both anxiety and depression
Time Frame
4 months
Title
STARR-15 ) Standard test for asthma, rhinitis and chronic rhinosinusitis (15 questions)
Description
There is no minimum or maximum yet
Time Frame
4 months
Title
ACT - Asthma Control Test
Description
min. 5 (poor control of asthma), max. 25 (complete control of asthma),
Time Frame
4 months
Title
ACQ-7 - Asthma Control Questionnaire
Description
min. 0 point= complete control of asthma, max 6 point= poor control of asthma Rigtig dårlig kontrol er > 1.5
Time Frame
4 months
Title
ESS - EPWORTH SLEEPINESS SCALE
Description
min=0 point= normal sleep, max. 24 point= severe sleepiness.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vibeke P Backer
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
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Adherence in Global Airways
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