Evaluation of an Integrated Care Project (ediva)

Charité University Medicine Berlin

Status: Completed

Conditions: Asthma; Allergic Rhinitis; Migraine; Depression; Atopic Eczema; Headache

Study type: Observational

Funder types: Other

Identifiers

NCT01854580

1-Witt

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,960 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

3,960 participants in 2 patient groups

Integrated care

Description:

Insured people in the Techniker Krankenkasse that are registered in the integrated care project.

Control group

Description:

Insured people in the Techniker Krankenkasse that are not registered in the integrated care project.