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Clinical Trials/NCT05531370
NCT05531370
Active, not recruiting
Not Applicable

Implementation of Evidence-based Breathing Retraining for Patients with Asthma in Region Zealand, Denmark

Naestved Hospital1 site in 1 country300 target enrollmentJune 30, 2022
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Naestved Hospital
Enrollment
300
Locations
1
Primary Endpoint
Adoption of intervention (Uptake)
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 30, 2022
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Adoption of intervention (Uptake)

Time Frame: Through study completion, an average of 1 year

Organization-related (Pulmonologists, general practioners, physiotherapists) outcome: Proportion of general practices and of hospitals that will adopt BR.

Implementation of intervention (Fidelity)

Time Frame: Through study completion, an average of 1 year

Organization-related (physiotherapists) outcome: % of contents delivered as planned assessed by a checklist of key aspects in the breathing retraining-intervention.

Feasibility of online sessions in Hybrid delivery mode of BR (H-BR) (Acceptability)

Time Frame: Through study completion, an average of 1 year

Patient- and Organization-related (physiotherapists) outcome: assessed by a semi-structured interview.

Effectiveness: MiniAsthma Quality of Life Questionnaire, MiniAQLQ

Time Frame: Through study completion, an average of 1 year

Patient-related outcome, disease specific quality of life questionnaire. 7-point Likert scales from 1-7, 1 = worse outcome, 7 = better outcome. Success rates of improvements minus deteriorations of individual effects, measured at 12 month follow up.

Secondary Outcomes

  • Objective steps per day (average)(Change from baseline to 12 month)
  • MiniAsthma Quality of Life Questionnaire, MiniAQLQ(Change from baseline to 12 months)
  • Objective physical activity level(Change from baseline to 12 month)
  • Breathing pattern observation(Change from baseline to 12 month)

Study Sites (1)

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