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Implementation of Evidence-based Breathing Retraining for Patients With Asthma in Region Zealand (EmBRAiZ)

Primary Purpose

Asthma

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Breathing Retraining
Sponsored by
Naestved Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Implementation, Asthma, Breathing Retraining

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Doctor diagnosed asthma;
  • Incompletely controlled asthma or worse: Asthma Control Questionnaire (ACQ5) score ≥0.8;
  • Moderate inhaled cortico steroids (ICS) dose + ≥1 second controller;
  • If patient in specialist care: ≥2 visits (i.e., to achieve optimized/ stable pharmacotherapy).

Exclusion Criteria:

  • Unwilling to participate;
  • Unable to participate in the intervention due to physical or mental condition;
  • Unable to read/write Danish.

Sites / Locations

  • Naestved HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breathing Retraining (BR)

Arm Description

Patients will receive three sessions (60 min, 30 min, 30 min) of breathing retraining (BR), 1-to-1 with a trained physiotherapist. As preferred by the patient: Hybrid delivery mode of BR (H-BR): First session on-site at hospital/clinic for initial assessment and introduction, and following sessions online (MedComs VDX platform or equal; participants access using web cam and sound on smart phone, tablet, or pc). Ordinary delivery of BR: Three sessions on-site at hospital/clinic.

Outcomes

Primary Outcome Measures

Adoption of intervention (Uptake)
Organization-related (Pulmonologists, general practioners, physiotherapists) outcome: Proportion of general practices and of hospitals that will adopt BR.
Implementation of intervention (Fidelity)
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)
Patient- and Organization-related (physiotherapists) outcome: assessed by a semi-structured interview.
Effectiveness: MiniAsthma Quality of Life Questionnaire, MiniAQLQ
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 Outcome Measures

MiniAsthma Quality of Life Questionnaire, MiniAQLQ
Patient-related outcome: Mean of disease specific quality of life questionnaire. 7-point Likert scales from 1-7, 1 = worse outcome, 7 = better outcome.
Breathing pattern observation
Patient-related outcome. Pre-defined key aspects of the breathing pattern assessed qualitatively observation by the physiotherapist.
Objective physical activity level
Patient-related outcome. Objectively measured physical activity and inactivity using combined wearable thigh and wrist accelerometers, worn for seven consecutive days.
Objective steps per day (average)
Patient-related outcome. Objectively measured steps per day using combined wearable thigh and wrist accelerometers, worn for seven consecutive days.

Full Information

First Posted
July 4, 2022
Last Updated
April 26, 2023
Sponsor
Naestved Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05531370
Brief Title
Implementation of Evidence-based Breathing Retraining for Patients With Asthma in Region Zealand
Acronym
EmBRAiZ
Official Title
Implementation of Evidence-based Breathing Retraining for Patients With Asthma in Region Zealand, Denmark
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 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
Name of the Sponsor
Naestved Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Implementation, Asthma, Breathing Retraining

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breathing Retraining (BR)
Arm Type
Experimental
Arm Description
Patients will receive three sessions (60 min, 30 min, 30 min) of breathing retraining (BR), 1-to-1 with a trained physiotherapist. As preferred by the patient: Hybrid delivery mode of BR (H-BR): First session on-site at hospital/clinic for initial assessment and introduction, and following sessions online (MedComs VDX platform or equal; participants access using web cam and sound on smart phone, tablet, or pc). Ordinary delivery of BR: Three sessions on-site at hospital/clinic.
Intervention Type
Other
Intervention Name(s)
Breathing Retraining
Other Intervention Name(s)
Breathing Exercises
Intervention Description
Conforming the real-world setting, all participants will continue standard asthma care, i.e., acute and planned visits at GP or pulmonologist. BR aims to normalize the inhaled volume, nasal inhalation, exhalation to the resting position of the chest (functional residual capacity, FRC), use of the diaphragm muscle, and to move lower parts of the chest in a frequency of 12-16 per minute. This pattern is initially trained in rest (e.g., side lying or sitting), then during physical activity (e.g., walking). Uncontrolled coughing, frequent yawning or sighing is handled by a suppression technique. Relaxation technique is introduced as a separate activity but to be combined with the breathing pattern method to be used in both resting and as possible during physical activity.
Primary Outcome Measure Information:
Title
Adoption of intervention (Uptake)
Description
Organization-related (Pulmonologists, general practioners, physiotherapists) outcome: Proportion of general practices and of hospitals that will adopt BR.
Time Frame
Through study completion, an average of 1 year
Title
Implementation of intervention (Fidelity)
Description
Organization-related (physiotherapists) outcome: % of contents delivered as planned assessed by a checklist of key aspects in the breathing retraining-intervention.
Time Frame
Through study completion, an average of 1 year
Title
Feasibility of online sessions in Hybrid delivery mode of BR (H-BR) (Acceptability)
Description
Patient- and Organization-related (physiotherapists) outcome: assessed by a semi-structured interview.
Time Frame
Through study completion, an average of 1 year
Title
Effectiveness: MiniAsthma Quality of Life Questionnaire, MiniAQLQ
Description
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.
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
MiniAsthma Quality of Life Questionnaire, MiniAQLQ
Description
Patient-related outcome: Mean of disease specific quality of life questionnaire. 7-point Likert scales from 1-7, 1 = worse outcome, 7 = better outcome.
Time Frame
Change from baseline to 12 months
Title
Breathing pattern observation
Description
Patient-related outcome. Pre-defined key aspects of the breathing pattern assessed qualitatively observation by the physiotherapist.
Time Frame
Change from baseline to 12 month
Title
Objective physical activity level
Description
Patient-related outcome. Objectively measured physical activity and inactivity using combined wearable thigh and wrist accelerometers, worn for seven consecutive days.
Time Frame
Change from baseline to 12 month
Title
Objective steps per day (average)
Description
Patient-related outcome. Objectively measured steps per day using combined wearable thigh and wrist accelerometers, worn for seven consecutive days.
Time Frame
Change from baseline to 12 month
Other Pre-specified Outcome Measures:
Title
Ashma severity by Global Initiative for Asthma (GINA) treatment steps
Description
Patient-related outcome. Asthma severity assessed by pharmacotherapy level, calculated into GINA treatment steps 1-5 (1 = mild asthma, 5 = severe asthma), using a questionnaire completed by the physiotherapist during an interview with the patient.
Time Frame
Change from baseline to 12 month
Title
Adverse events (Safety)
Description
Patient-related outcome; number, % caused discontinuation.
Time Frame
Post-intervention (3-month)
Title
Asthma Control Questionnaire, ACQ5
Description
Patient-related outcome: ACQ5 i.e. item 1-5 of the ACQ. Mean of asthma symptom level questionnaire; 7-point Likert scales from 0-6, 0 = better outcome, 6 = worse outcome.
Time Frame
Change from baseline to 12 month
Title
Number of online sessions delivered
Description
Number, % of total sessions.
Time Frame
Post-intervention (3-month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen H Andreasson, Dr.
Phone
+45 24254926
Email
khad@regionsjaelland.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lars H Tang, Assoc.Prof.
Email
larta@regionsjaelland.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren T Skou, Prof.
Organizational Affiliation
Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lars H Tang, Assoc.Prof.
Organizational Affiliation
Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cecilie L Egholm, PostDoc.
Organizational Affiliation
Naestved-Slagelse-Ringsted Hospitals, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Uffe Bodtger, Prof.
Organizational Affiliation
Zealand University Hospital; University of Southern Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mike Thomas, Prof.
Organizational Affiliation
Primary Care Research University of Southampton, UK
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karen H Andreasson, Dr.
Organizational Affiliation
Naestved-Slagelse-Ringsted Hospitals; University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naestved Hospital
City
Naestved
State/Province
Region Zealand
ZIP/Postal Code
4700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen H Andreasson, Dr.
Email
khad@regionsjaelland.dk

12. IPD Sharing Statement

Learn more about this trial

Implementation of Evidence-based Breathing Retraining for Patients With Asthma in Region Zealand

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