NCT00516633

Brief Summary

We wanted to investigate if it was possible to improve adherence to prescriptions and advice in pre-school children with newly diagnosed asthma. The intervention was intense information and support in the form of four group discussions with the parents of four children in close connection to diagnosing the child. The control children received the usual care with individual polyclinic visits to the physi-cian/nurse. We evaluated the effect with the help of questionnaires, physical examinations, blood tests, lung function tests and control of treatment adherence after 18 months and 6 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Apr 1998

Longer than P75 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

April 1, 1998

Completed
7.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2007

Completed
Last Updated

August 15, 2007

Status Verified

August 1, 2007

First QC Date

August 13, 2007

Last Update Submit

August 14, 2007

Conditions

Keywords

AsthmaAdherenceBurden of asthmaQuality of lifeQuestionnaires

Outcome Measures

Primary Outcomes (1)

  • Adherence

    18 months and 6 years

Secondary Outcomes (1)

  • Burden of asthma on the individual and on the health care system

    18 months and 6 years

Study Arms (2)

CG

NO INTERVENTION

The control group had regular individual information and support in connection with ordinary clinical follow-ups

IG

EXPERIMENTAL

The intervention group had extra support and information in the form of four group discussions with parents

Behavioral: Extra information and support

Interventions

Four group discussions with parents in close connection to diagnosing the children

IG

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of asthma and fullfilling the criteria utilized to indicate high risk for persistent asthma: the presence of atopic disease among close relatives, confirmed allergy, symptoms of another atopic disease or asthma that appeared between bouts of the common cold.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barn-ungdomsmedicinska mottagningen VC Gripen

Karlstad, 651 12, Sweden

Location

Related Publications (3)

  • Hederos CA, Janson S, Hedlin G. Group discussions with parents have long-term positive effects on the management of asthma with good cost-benefit. Acta Paediatr. 2005 May;94(5):602-8. doi: 10.1111/j.1651-2227.2005.tb01946.x.

  • Hederos CA. Neuropsychologic changes and inhaled corticosteroids. J Allergy Clin Immunol. 2004 Aug;114(2):451-2. doi: 10.1016/j.jaci.2004.03.045. No abstract available.

  • Hederos CA, Janson S, Andersson H, Hedlin G. Chest X-ray investigation in newly discovered asthma. Pediatr Allergy Immunol. 2004 Apr;15(2):163-5. doi: 10.1046/j.1399-3038.2003.00098.x.

MeSH Terms

Conditions

Asthma

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Gunilla Hedlin, Professor

    Karolinska Institutet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 15, 2007

Study Start

April 1, 1998

Study Completion

December 1, 2005

Last Updated

August 15, 2007

Record last verified: 2007-08

Locations