Improving teenage self-management of asthma
| ISRCTN | ISRCTN47088337 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47088337 |
| Protocol serial number | 19303 |
| Sponsor | Southampton University Hospitals NHS Trust & University of Southampton |
| Funder | Asthma UK |
- Submission date
- 22/07/2015
- Registration date
- 23/07/2015
- Last edited
- 20/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Simone Holley
Public
Public
Southampton General Hospital
Mailpoint 803
Southampton University Hospital NHS Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Screening, Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Improving teenage self-management of asthma: randomised controlled trial |
| Study acronym | ITSMyAsthma RCT |
| Study objectives | The aim of this study is to assess the effectiveness of a teenage asthma toolkit, designed to support healthcare professionals to empower teenagers to self manage their asthma. |
| Ethics approval(s) | 15/NW/0551 |
| Health condition(s) or problem(s) studied | Topic: Children, Respiratory disorders; Subtopic: All Diagnoses, Respiratory (all Subtopics); Disease: Respiratory, All Diseases |
| Intervention | Clinic – HCPs (doctors and nurses) will use the self-efficacy questionnaire to identify where participants need additional support to improve their asthma self-management skills. The needs of individual patients will then be used to identify specific behavioural interventions. These interventions will be applied in clinic. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
The primary outcome measure will be the asthma control test |
| Key secondary outcome measure(s) |
N/A |
| Completion date | 30/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 350 |
| Key inclusion criteria | 1. Aged 12-18 years 2. Able to consent to participation in the study 3. Doctor diagnosed asthma 4. Prescription of a regular prophylactic medication for asthma (eg inhaled corticosteroid, montelukast) |
| Key exclusion criteria | 1. Lack of informed consent from them or their parent 2. Very poorly controlled asthma that, in the view of their paediatrician, requires a step up in preventer therapy 3. Significant other long term medical condition that has a day to day impact on their lives (should not usually include con-existing atopic diseases) |
| Date of first enrolment | 15/07/2015 |
| Date of final enrolment | 31/05/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Southampton General Hospital
Mailpoint 803
Southampton University Hospital NHS Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom
Southampton University Hospital NHS Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 20/05/2021 | No | No | ||
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/05/2021: Publication reference added.
16/05/2017: The overall trial end date has been updated from 31/05/2016 to 30/09/2017.
07/03/2016: Verifying study status with principal investigator.
