Condition category
Respiratory
Date applied
16/11/2017
Date assigned
23/11/2017
Last edited
07/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bertine Flokstra - de Blok

ORCID ID

Contact details

University Medical Center Groningen
PO Box 196
Groningen
9700 AD
Netherlands
+31 (0)50 3616687
b.m.j.flokstra@umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Development and feasibility of an Allergy Management Support System (AMSS) for primary care

Acronym

AMSS

Study hypothesis

The aim of this study is to develop a Allergy Management Support Service for primary care.

Ethics approval

Ethics committee of University Medical Center Groningen, 23/05/2013, refs: METc 2011/273, METc 2013/129

Study design

Interventional

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information

Condition

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

Phase

Drug names

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 trial start date

01/09/2009

Overall trial end date

01/09/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. General practitioners (GP)
2. Allergic patient or parent of allergic child with sIgE test

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

20 GPs and 100 patients

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/02/2010

Recruitment end date

01/09/2015

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
9700 AD
Netherlands

Sponsor information

Organisation

University Medical Center Groningen

Sponsor details

PO Box 196
Groningen
9700 AD
Netherlands
+31 (0)50 3616687
b.m.j.flokstra@umcg.nl

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Phadia BV

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

ALK Abelló BV

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Universitair Medisch Centrum Groningen

Alternative name(s)

University Medical Center Groningen, UMCG

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Netherlands

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
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.

Intention to publish date

01/01/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29872524

Publication citations

Additional files

Editorial Notes

07/06/2018: Publication reference added.