Allergy management support service
| ISRCTN | ISRCTN36780877 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36780877 |
| Secondary identifying numbers | 1 |
- Submission date
- 16/11/2017
- Registration date
- 23/11/2017
- Last edited
- 07/06/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Management of allergic patients in the population is becoming more difficult because of increases both in complexity and prevalence. Although general practitioners (GPs) are expected to play an important role in the care of allergic patients, they often feel ill equipped for this task. Therefore, we aim to develop an Allergy Management Support System (AMSS) for primary care and to test the feasibility of this AMSS for primary care. Through literature review, interviewing and testing in secondary and primary care patients, an allergy history questionnaire will be constructed by allergists, dermatologists, GPs, and researchers based on primary care and specialists’ allergy guidelines and their clinical knowledge. Patterns of AMSS questionnaire responses and sIgE-test outcomes will be used to identify diagnostic categories and to develop corresponding management recommendations. Validity of the AMSS will be investigated by comparing specialist (gold standard) and AMSS diagnostic categories. The aim of this feasibility study is to evaluate if the AMSS is feasible when >70% of the AMSS recommendations are sent to the GP within ten working days of sIgE-testing.
Who can participate?
General practitioners and allergy patients/parents of an allergic child.
What does the study involve?
Participants complete the AMSS questionnaire which consists of 12 (mainly) multiple-choice questions on symptoms, triggers, severity, medication and symptom control of their allergic conditions. Participating GPs are allocated to one of two groups. Those in the first group receive the AMSS questionnaire in in addition to sIgE-test results. Those in the second group receive only the to sIgE-test results. GPs in both groups completed a short questionnaire with multiple-choice questions on diagnosis and management (medication, referral and/or non-pharmacotherapeutic recommendations) on two occasions: at the time of inclusion of the patient and at the time the sIgE test outcomes were known.
What are the possible benefits and risks of participating?
Direct benefits for GPs taking part in the study is receiving recommendations in addition to sIgE test outcomes. There are no direct risks for those taking part in the study.
Where is the study run from?
University Medical Center Groningen (Netherlands)
When is the study starting and how long is it expected to run for?
September 2009 to September 2016
Who is funding the study?
1. Phadia BV (Netherlands)
2. ALK Abelló BV (Netherlands)
3. University Medical Center Groningen (Netherlands)
Who is the main contact?
Dr Bertine Flokstra - de Blok
b.m.j.flokstra@umcg.nl
Contact information
Scientific
University Medical Center Groningen
PO Box 196
Groningen
9700 AD
Netherlands
| Phone | +31 (0)50 3616687 |
|---|---|
| b.m.j.flokstra@umcg.nl |
Study information
| Study design | Interventional |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information |
| Scientific title | Development and feasibility of an Allergy Management Support System (AMSS) for primary care |
| Study acronym | AMSS |
| Study objectives | The aim of this study is to develop a Allergy Management Support Service for primary care. |
| Ethics approval(s) | Ethics committee of University Medical Center Groningen, 23/05/2013, refs: METc 2011/273, METc 2013/129 |
| Health condition(s) or problem(s) studied | Allergy: rhinitis, asthma, atopic dermatitis and food allergy |
| Intervention | This study uses a cluster randomised controlled design. Participants are randomly allocated to one of two groups: the intervention or the control group. GPs in the intervention group receive Allergy Management Support System (AMSS) recommendations in addition to sIgE test results, while GPs in the control group perform usual care based on sIgE test results only. At inclusion, patients completed the AMSS questionnaire which consists of 12 (mainly) multiple-choice questions on symptoms, triggers, severity, medication and symptom control of their allergic conditions. GPs in both groups completed a short questionnaire with multiple-choice questions on diagnosis and management (medication, referral and/or non-pharmacotherapeutic recommendations) on two occasions: at the time of inclusion of the patient and at the time the sIgE test outcomes were known. |
| Intervention type | Other |
| Primary outcome measure | Feasibility of the AMSS is assessed using the percentage of AMSS recommendations sent to the GP within 10 working days of the slgE testing. |
| Secondary outcome measures | There are no secondary outcome measures. |
| Overall study start date | 01/09/2009 |
| Completion date | 01/09/2016 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 20 GPs and 100 patients |
| Key inclusion criteria | 1. General practitioners (GP) 2. Allergic patient or parent of allergic child with sIgE test |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 01/09/2015 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Netherlands
Sponsor information
University/education
PO Box 196
Groningen
9700 AD
Netherlands
| Phone | +31 (0)50 3616687 |
|---|---|
| b.m.j.flokstra@umcg.nl | |
"ROR" |
https://ror.org/03cv38k47 |
Funders
Funder type
Industry
No information available
No information available
Government organisation / Local government
- Alternative name(s)
- University Medical Center Groningen, UMCG
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/01/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. B.M.J. Flokstra – de Blok, b.m.j.flokstra@umcg.nl. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/05/2018 | Yes | No |
Editorial Notes
07/06/2018: Publication reference added.
