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Intervention Study to Improve Adherence in Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00516633
First Posted: August 15, 2007
Last Update Posted: August 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Värmland County Council, Sweden
  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
Intervention Model: Parallel Assignment
Masking: None (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?

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 13, 2007
First Posted: August 15, 2007
Last Update Posted: August 15, 2007
Last Verified: August 2007

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