Allergic Rhinitis, Asthma, Atopic Eczema, Depression, Headache, Migraine
Conditions
Keywords
Comparative effectiveness research, health economic evaluation
Brief summary
The purpose of the study is to investigate the effectiveness and cost-effectiveness of the integrated care program of a statutory health insurance offering additional homeopathic treatment to their members
Detailed description
The German statutory health insurance 'Techniker Krankenkasse' offers an integrated additional homeopathic treatment. To date, this offer has not been evaluated. Therefore we aim to investigate the effectiveness as well as the cost-effectiveness of this program in adolescents (12-17 years) and adults with various chronic diseases. In an observational study we plan to compare patients participating in the integrated care project with matched insured persons from the Techniker Krankenkasse that do not participate in this program. Matching will be based on gender, age and diagnosis. Regarding the diagnosis, we plan to include adolescents with: asthma, allergic rhinitis and atopic eczema; and adults with asthma, allergic rhinitis and atopic migraine, headache and depression. To measure effectiveness, patients have to complete diagnosis-specific questionnaires at baseline and 3, 6 and 12 months. The primary outcome for each diagnosis is measured with diagnosis-specific questionnaire at 6 months. Secondary outcomes include quality of life (SF-12) at 3, 6 and 12 months as well as the diagnosis-specific questionnaires at 3 and 12 months.
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly registered for the integrated care program * Insured for at least 1 year at the Techniker Krankenkasse * Having access to the internet and e-mails at least once a week * Adults with any of the following diagnoses: asthma, allergic rhinitis, atopic eczema, migraine, tension headache, depression * Adolescents with any of the following diagnoses: asthma, allergic rhinitis, atopic eczema * informed written consent
Exclusion criteria
* Participation in a disease-management program * Participation in an intervention study * Cancer diagnosis * current usage of a complementary therapy (control group only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis-specific patient reported outcomes | 6 months | Questionnaires: asthma: AQLQ, (PAQLQ for adolescents) allergic rhinitis: RQLQ (AdolRQLQ for adolescents) atopic eczema: DLQI (CDLQI for adolescents) migraine and headache: days with headache (last 4 weeks) tension headache: days of headache within the last 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life (SF-12) | 3, 6 and 12 months | — |
| Costs | 3, 6, and 12 months period | — |
| Diagnoses-specific patient reported outcomes | 3 and 12 months | same parameters as for primary outcome, but different time point |
Countries
Germany
Outcome results
None listed