Intervention Study to Improve Adherence in Asthma

This study has been completed.
Sponsor:
Information provided by:
Värmland County Council, Sweden
ClinicalTrials.gov Identifier:
NCT00516633
First received: August 13, 2007
Last updated: August 14, 2007
Last verified: August 2007
  Purpose

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.


Condition Intervention
Asthma
Behavioral: Extra information and support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Improved Information in the Form of Group Discussions With Parents of Newly Diagnosed Asth-Matic Children Lead to a Better Quality of Life for the Families, an Improved Adherence and Better Devel-Opment of the Lung Function of the Children?

Resource links provided by NLM:


Further study details as provided by Värmland County Council, Sweden:

Primary Outcome Measures:
  • Adherence [ Time Frame: 18 months and 6 years ]

Secondary Outcome Measures:
  • Burden of asthma on the individual and on the health care system [ Time Frame: 18 months and 6 years ]

Enrollment: 60
Study Start Date: April 1998
Study Completion Date: December 2005
Arms Assigned Interventions
No Intervention: CG
The control group had regular individual information and support in connection with ordinary clinical follow-ups
Experimental: IG
The intervention group had extra support and information in the form of four group discussions with parents
Behavioral: Extra information and support
Four group discussions with parents in close connection to diagnosing the children

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00516633

Locations
Sweden
Barn-ungdomsmedicinska mottagningen VC Gripen
Karlstad, Sweden, 651 12
Sponsors and Collaborators
Värmland County Council, Sweden
Investigators
Study Chair: Gunilla Hedlin, Professor Karolinska Institutet Stockholm Sweden
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00516633     History of Changes
Other Study ID Numbers: LIVFOU-8215
Study First Received: August 13, 2007
Last Updated: August 14, 2007
Health Authority: Sweden: The National Board of Health and Wellfare

Keywords provided by Värmland County Council, Sweden:
Asthma
Adherence
Burden of asthma
Quality of life
Questionnaires

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 01, 2014