- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Joanne Walsh, MSc
- Telefonnummer: 01-4022300
- E-post: joannewalsh21@rcsi.com
Studiesteder
-
-
D
-
Dublin, D, Irland, D15 AXV5
- Rekruttering
- Royal College of Surgeons Ireland
-
Ta kontakt med:
- Joanne Walsh, MSc
- Telefonnummer: 01-4022300
- E-post: joannewalsh21@rcsi.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: WASP intervetion
|
all participants will received the WASP intervention which includes (asthma education, self-management training and behaviour change strategies)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of implementation
Tidsramme: 6 months
|
In terms of: recruitment, retention, response rates and service users' views of the intervention
|
6 months
|
|
Education
Tidsramme: 6 months
|
Establish the nurses' frequency of education implementation
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Asthma Control Test Questionnaire
Tidsramme: 6 months
|
To determine level of asthma control
|
6 months
|
|
Modified asthma self-efficacy questionnaire
Tidsramme: 6 months
|
To determine level of asthma self-efficacy
|
6 months
|
|
Mini Asthma Quality of Life Questionnaire (mAQLQ)
Tidsramme: 6 months
|
To determine level of asthma associated quality of life
|
6 months
|
|
Spirometry - Forced expiratory volume in 1 second (FEV1)
Tidsramme: 6 months
|
To monitor lung function - using FEV1
|
6 months
|
|
Spirometry - Forced Vital Capacity (FVC)
Tidsramme: 6 months
|
To monitor lung function using FVC measurement
|
6 months
|
|
Spirometry - Peak expiratory flow (PEF)
Tidsramme: 6 months
|
To monitor lung function using PEF measurements
|
6 months
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- REC202602014
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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