NCT02571413

Brief Summary

Correct methods and compliance of intranasal corticosteroid (INCS) is very important for the treatment of allergic rhinitis (AR). The animated cartoon-aided teaching of INCS administration was created to decrease workload of health care professionals. The aim of this study is to compare the achievement of the children with AR in using INCS between the group which were instructed by animated cartoon-aided teaching or oral presentation without demonstration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
5.4 years until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

11 months

First QC Date

January 11, 2010

Last Update Submit

May 2, 2016

Conditions

Keywords

animated cartoon-aided teachingoral presentationallergic rhinitisintranasal corticosteroidhow to use intranasal corticosteroid

Outcome Measures

Primary Outcomes (1)

  • Scores of the correct method of intranasal corticosteroid administration technique before and after teaching

    compare the scores before and after teaching( immediately and 3 months after)

    1 year

Study Arms (2)

oral presentation

OTHER

Scoring the correct use of INC before, immediate after and 3 months after oral presentation without demonstration "how to use INCS"

Other: score before teachingOther: score immediately after teachingOther: score 3 months after teaching

animated cartoon-aided VDO

OTHER

Scoring the correct use of INC before, immediate after and 3 months after animated cartoon-aided teaching "how to use INCS"

Other: score before teachingOther: score immediately after teachingOther: score 3 months after teaching

Interventions

score the check-point of correct INCS usage before teaching

animated cartoon-aided VDOoral presentation

score the check-point of correct INCS usage immediately after teaching

animated cartoon-aided VDOoral presentation

score the check-point of correct INCS usage 3 months after teaching

animated cartoon-aided VDOoral presentation

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with 5 - 16 year old
  • children with allergic rhinitis

You may not qualify if:

  • history of intranasal corticosteroid use
  • history of other underlying disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

AsthmaRhinitis, Allergic

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Nualanong Visitsunthorn, Prof

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Somying Indradat

Study Record Dates

First Submitted

January 11, 2010

First Posted

October 8, 2015

Study Start

May 1, 2009

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

May 3, 2016

Record last verified: 2016-05

Locations