Intervention Study to Improve Adherence in Asthma
This study has been completed.
Sponsor:
Värmland County Council, Sweden
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
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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
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 June 18, 2013