Evaluation of an Integrated Care Project

Depression Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854580
• Other study ID #: 1-Witt
• Status: Completed
• Start date: March 2013
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3960
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Atopic Eczema
• Depression
• Dermatitis, Atopic
• Headache
• Migraine
• Rhinitis
• Rhinitis, Allergic

Locations

Country	Name	City	State
Germany	Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Health related quality of life (SF-12)		3, 6 and 12 months
Secondary	Costs		3, 6, and 12 months period
Secondary	Diagnoses-specific patient reported outcomes	same parameters as for primary outcome, but different time point	3 and 12 months