AIS LIFE 

Beneficiary responsible for implementation: IFC-CNR Action in progress according the project protocol.

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Status: Completed

 

Foreseen start date: July 1st 2014                               Actual start date: July 1st 2014

Foreseen end date: May 31st 2017                             Actual end date: May 31st 2017

 

Action B2 has the purpose of designing and applying the research questionnaires needed to collect data on respiratory health status, disease exacerbations, symptoms, risk factors, direct/indirect costs, quality of life in the selected samples. Basically, the action had to develop: a) health questionnaire, b) satisfaction questionnaire and c) daily diary - to be filled in by the investigated subjects.

 

Update:

The Screening Questionnaire, the Health Questionnaire and the Satisfaction Questionnaire were completed in Italian and English versions according to pre-existing validated questionnaires and partner's revisions (Deliverable B2.1, see Annex 7.2.12 7.2.13, 7.2.14,

7.2.15). Indeed, the Screening Questionnaire was not expected within B2.1 deliverable but it has  been  proposed  and  accepted  by  the  Coordinators  and  the  beneficiaries,  in  order  to optimize and standardize the sample enrolment.

The Symptom module (patient's hay fever diary - PHD) for PPI has been provided by MUW

partner for an appropriate translation from English to Italian.

A brief guide to the mobile PPI application and the daily diary data entry form were realized

(Italian and English versions) (Deliverable B2.1, Annex 7.2.16). Study sample

The field survey will be performed on subjects affected by pollen allergies in the three

involved countries (Italy, France and Austria). The same inclusion criteria and methodological protocol will be used in the three countries, apart from specific actions to be taken in case of need, in order to enlarge the samples.

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Performed activities

 

 

The activities carried out were:

 

1. realization of  the  Screening Questionnaire, the  Health  Questionnaire and  the Satisfaction Questionnaire in Italian and English  versions according to pre-existing validated  questionnaires and  partner's  revisions (Deliverable B2.1, Annex 7.2.12,

7.2.13, 7.2.14, 7.2.15 submitted in Mid Term Report);

 

 

2. translation from English to Italian of the Symptom module (patient's hay fever diary

- PHD) provided by MUW partner for PPI implementation;

 

 

3.  realization of a brief guide to the mobile PPI application and the Daily Diary data entry form (Italian and English versions) (Deliverable B2.1, Annex 7.2.16 submitted in Mid Term Report);

 

 

4. preparation of excel forms for imputing Italian, French and Austrian data collected through the Screening Questionnaires, Health Questionnaires (I and II observational phases) and Satisfaction Questionnaires (Annex 7.2.17, 7.2.18. 7.2.19)

5. creation of the centralized database relating to the I observational phase for the assessment  of the health status associated with pollen-related  asthma and allergic rhinitis through the Health Questionnaire data;

 

 

6. creation of the centralized database relating to the II observational phase for the assessment  of the health status associated with pollen-related  asthma and allergic rhinitis through the Health Questionnaire data;

 

 

7. creation of the centralized database relating to the II observational phase for the assessment of perceived usefulness and accessibility of the IIS and PPI through the Satisfaction Questionnaire data;

 

 

8. creation of the longitudinal  centralized database relating to the I-II observational phases for the assessment of the effects of using the AIS on allergy sufferers in terms of disease control, quality of life,  drugs consumption,  indirect costs,  use of health service;

9. realization of quality control and validation of the data collected by questionnaires. The research tools  developed in  Action  B2, to  collect data on  respiratory health

status, disease exacerbations, symptoms, risk factors, direct/indirect  costs, quality of

life in the selected samples, were used within the field surveys carried out in Action

B1.

In particular, the Health Questionnaire was filled in during the I and II observational phase by the three groups of subjects (A, B, C); the Satisfaction Questionnaire was filled in during the II observational phase by the two groups of intervention (A, B); the Daily Diary was filled in during the implementation phase of the PPI by the group B.

 

It should be noted that the Screening Questionnaire was not expected within Action B2 but it has been proposed and accepted by the Coordinators and the beneficiaries, in order to optimize and standardize the sample enrolment in the three countries.

In particular, in order to perform statistical analyses, data collected in Pisa, Paris, and Vienna, were entered directly into SPSS or by means of an Excel data matrix in order to prepare the following Databases:

1.       Satisfaction database, that includes data on accessibility, easiness of use, and perceived usefulness of AIS;

2.       Health databases, that include data on health status, quality of life and disease control related to  allergic rhinitis/asthma, collected in Phase 1, Phase 2 and Phases 1-

2;

3.       Environmental database 1, that includes daily data of considered air pollutants and pollens;

4.       Environmental  database 2,  that  included  annual  cumulative  indicators  of pollens.

 

 

It should be noted that a comprehensive statistics of the field surveys, I and II phases, with all three countries analysed together is presented in the Deliverables C2.1 and C2.2 (Annex 7.2.23 and 7.2.24) which include all the data and all the questionnaires collected from the enrolled patients.

 

 

Indicators of progress

• Number of Daily Dairies structured and ready for release by Month 4: 2

• Number of Health Questionnaires structured and ready for release by Month 12: 2

• Number of Satisfaction Questionnaires structured and ready for release by Month

12: 2

• Number of centralised databases ready for data insertion from all project areas by

Month 20, Month 32 and Month 33: 6.