- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07609134
The Development of the Walsh Asthma Self-management Programme and Feasibility of Implementation in Adults With Asthma in Primary Care
Asthma is a common medical condition in Ireland. Adult patients tend to have periods when their asthma is stable and periods when it worsens. In order to reduce these periods of worsening asthma, effective ongoing management is required day to day by adults with asthma. Teaching adults how to manage their asthma effectively, plays a huge role in improving their asthma and having a better overall quality of life. This education on managing asthma has many different parts to it. Most adults will discover they have asthma through their general practitioner (GP) and it will be continued to be checked and managed through their GP or general practice nurse (GPN) in their primary care clinic for the duration of their lives.
This research study is taking place to find out if a new education programme, will help adults manage their asthma better and improve the symptoms of asthma, reducing its overall impact on day-to-day life. This study is also looking at how easy it is to introduce and for nurses to deliver this study within a GP/ primary care centre. This study is to find out if this education programme works in a real life setting and if it can lead to better control of asthma for adults.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joanne Walsh, MSc
- Phone Number: 01-4022300
- Email: joannewalsh21@rcsi.com
Study Locations
-
-
D
-
Dublin, D, Ireland, D15 AXV5
- Recruiting
- Royal College of Surgeons Ireland
-
Contact:
- Joanne Walsh, MSc
- Phone Number: 01-4022300
- Email: joannewalsh21@rcsi.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults over 18 years old
- Adults who meet one of the following criteria:
a physician's diagnosis of asthma; coded as asthma (R96) as per the international classification of primary care (ICPC) or international classification of diseases (ICD) code J45 with associated use of asthma medications for 6 months prior to study enrolment.
Exclusion Criteria:
- Adults under 18 years old
- Adults with no diagnosis of asthma
- Adults receiving asthma education in a specialist hospital or community setting
- Adults unable to give informed consent
- Smoking ≥ 10 Pack Year History
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: WASP intervetion
|
all participants will received the WASP intervention which includes (asthma education, self-management training and behaviour change strategies)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of implementation
Time Frame: 6 months
|
In terms of: recruitment, retention, response rates and service users' views of the intervention
|
6 months
|
|
Education
Time Frame: 6 months
|
Establish the nurses' frequency of education implementation
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma Control Test Questionnaire
Time Frame: 6 months
|
To determine level of asthma control
|
6 months
|
|
Modified asthma self-efficacy questionnaire
Time Frame: 6 months
|
To determine level of asthma self-efficacy
|
6 months
|
|
Mini Asthma Quality of Life Questionnaire (mAQLQ)
Time Frame: 6 months
|
To determine level of asthma associated quality of life
|
6 months
|
|
Spirometry - Forced expiratory volume in 1 second (FEV1)
Time Frame: 6 months
|
To monitor lung function - using FEV1
|
6 months
|
|
Spirometry - Forced Vital Capacity (FVC)
Time Frame: 6 months
|
To monitor lung function using FVC measurement
|
6 months
|
|
Spirometry - Peak expiratory flow (PEF)
Time Frame: 6 months
|
To monitor lung function using PEF measurements
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC202602014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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