Evaluation of an Integrated Care Project

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of an Integrated Care Project of the Statutory Health Insurance Techniker Krankenkasse [Evaluation Des Integrierten Versorgungsangebots Der Techniker Krankenkasse]

Conditions
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Asthma, Allergic Rhinitis, Atopic Eczema, Migraine, Headache, Depression

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Integrated care<br>Insured people in the Techniker Krankenkasse that are registered in the integrated care project. | |
| Control group<br>Insured people in the Techniker Krankenkasse that are not registered in the integrated care project. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis-specific patient reported outcomes | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life (SF-12) |  | 3, 6 and 12 months | 
| Costs |  | 3, 6, and 12 months period | 
| Diagnoses-specific patient reported outcomes | same parameters as for primary outcome, but different time point | 3 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comparative effectiveness research, health economic evaluation