AIR2022: Adherence in Global Airways

Sponsor
Christiane Haase (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05553951
Collaborator
(none)
90
1
2
39
2.3

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Controlgroup
  • Behavioral: Intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Adherence in Global Airways - Difference Between Structured and Systematic Nursing Supervison vs Usual Care
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interventions group

will receive systematic and structured nursing supervison about their adherence

Behavioral: Intervention
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

Behavioral: Controlgroup
The control group and intervention group will receive daily text message reminders twice a week to take their medications and to rinse their nose.

Outcome Measures

Primary Outcome Measures

  1. MARS-5 L/N - Medication adherence report scale both for upper and lower airways [4 months]

    Min. 0 point= non adherent, max. 25 point=adherent

Secondary Outcome Measures

  1. SNOT-22 - The Sino-Nasal Outcome Test 22 [4 months]

    min. 0 point=no symptoms, max. 110 point=many symptoms.

  2. miniAQLQ - Mini asthma quality of life questionnaire [4 months]

    min. 1= all the time, max. 7= not at all

  3. HADS - Hospital Anxiety and Depression Scale [4 months]

    Min 0 point=no risk, Max 21 point=high risk. It applies both anxiety and depression

  4. STARR-15 ) Standard test for asthma, rhinitis and chronic rhinosinusitis (15 questions) [4 months]

    There is no minimum or maximum yet

  5. ACT - Asthma Control Test [4 months]

    min. 5 (poor control of asthma), max. 25 (complete control of asthma),

  6. ACQ-7 - Asthma Control Questionnaire [4 months]

    min. 0 point= complete control of asthma, max 6 point= poor control of asthma Rigtig dårlig kontrol er > 1.5

  7. ESS - EPWORTH SLEEPINESS SCALE [4 months]

    min=0 point= normal sleep, max. 24 point= severe sleepiness.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Otorhinolaryngology, Head and Neck Surgery & Audiology Copenhagen Denmark 2100

Sponsors and Collaborators

  • Christiane Haase

Investigators

  • Study Chair: Vibeke P Backer, Rigshospitalet, Denmark

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Christiane Haase, Clinical nurse specialist and Phd-student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT05553951
Other Study ID Numbers:
  • 2022-ENT-2- adherence
First Posted:
Sep 26, 2022
Last Update Posted:
Sep 26, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christiane Haase, Clinical nurse specialist and Phd-student, Rigshospitalet, Denmark
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 26, 2022