Clinical trial NCT05531370: Implementation of Evidence-based Breathing Retraining for Patients with Asthma in Region Zealand
Official title: Implementation of Evidence-based Breathing Retraining for Patients with Asthma in Region Zealand, Denmark
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma
Keywords: Implementation
Asthma
Breathing Retraining
Lead sponsor: Naestved Hospital
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to implement the evidence-based intervention breathing retraining into clinical care of patients with symptomatic asthma irrespective of asthma severity or comorbidities, and in a diverse multicentre setting to evaluate implementation outcomes. This will meet patients' needs and improve health and life situation in patients with uncontrolled asthma. Further, the study will evaluate implementation outcomes.

Detailed description: This study is a hybrid-designed prospective multicenter implementation evaluation study, in which the investigators secondarily will maintain measuring effectiveness of breathing retraining in a real-world setting including primary and secondary health care and add cross-sectorial co-operation. Thus, investigators include more primary outcomes.

The study is part of Exercise First-project, a collaboration of The National Health Service, Region Zealand and the research unit PROgrez, Department of Physiotherapy and Occupational Therapy at Næstved, Slagelse, Ringsted hospitals.

Eligibility criteria: Inclusion Criteria:

* Doctor diagnosed asthma;
* Incompletely controlled asthma or worse: Asthma Control Questionnaire (ACQ5) score ≥0.8;
* Residence (or asthma treatment program) in Region Zealand, Denmark;
* Able to read and understand Danish or available assistance to help understand information material, intervention content and respond to questionnaires.

Exclusion Criteria:

* Unwilling to participate;
* Unable to participate in the intervention due to physical or mental condition.

Primary outcomes:
measure: Adoption of intervention (Uptake)
timeFrame: Through study completion, an average of 1 year
measure: Implementation of intervention (Fidelity)
timeFrame: Through study completion, an average of 1 year
measure: Feasibility of online sessions in Hybrid delivery mode of BR (H-BR) (Acceptability)
timeFrame: Through study completion, an average of 1 year
measure: Effectiveness: MiniAsthma Quality of Life Questionnaire, MiniAQLQ
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: MiniAsthma Quality of Life Questionnaire, MiniAQLQ
timeFrame: Change from baseline to 12 months
measure: Breathing pattern observation
timeFrame: Change from baseline to 12 month
measure: Objective physical activity level
timeFrame: Change from baseline to 12 month
measure: Objective steps per day (average)
timeFrame: Change from baseline to 12 month
Other outcomes:
measure: Ashma severity by Global Initiative for Asthma (GINA) treatment steps
timeFrame: Change from baseline to 12 month
measure: Adverse events (Safety)
timeFrame: Post-intervention (3-month)
measure: Asthma Control Questionnaire, ACQ5
timeFrame: Change from baseline to 12 month
measure: Number of online sessions delivered
timeFrame: Post-intervention (3-month)
Locations:
city: Naestved
country: Denmark
facility: Naestved Hospital
state: Region Zealand
Study officials:
affiliation: Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark
name: Søren T Skou, Prof.
role: STUDY_CHAIR
affiliation: Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark
name: Lars H Tang, Assoc.Prof.
role: STUDY_CHAIR
affiliation: Naestved-Slagelse-Ringsted Hospitals, Denmark
name: Cecilie L Egholm, PostDoc.
role: STUDY_CHAIR
affiliation: Zealand University Hospital; University of Southern Denmark
name: Uffe Bodtger, Prof.
role: STUDY_CHAIR
affiliation: Primary Care Research University of Southampton, UK
name: Mike Thomas, Prof.
role: STUDY_CHAIR
affiliation: Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark
name: Karen H Andreasson, Dr.
role: PRINCIPAL_INVESTIGATOR
References: