Clinical trial NCT01854580: Evaluation of an Integrated Care Project
Official title: Evaluation of an Integrated Care Project of the Statutory Health Insurance Techniker Krankenkasse [Evaluation Des Integrierten Versorgungsangebots Der Techniker Krankenkasse]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Allergic Rhinitis
Atopic Eczema
Migraine
Headache
Depression
Keywords: Comparative effectiveness research
health economic evaluation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 3960
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Insured people of the statutory health insurance Techniker Krankenkasse in Germany

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Diagnosis-specific patient reported outcomes
timeFrame: 6 months
Secondary outcomes:
measure: Health related quality of life (SF-12)
timeFrame: 3, 6 and 12 months
measure: Costs
timeFrame: 3, 6, and 12 months period
measure: Diagnoses-specific patient reported outcomes
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite Universitätsmedizin Berlin
name: Claudia M Witt, MD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite-Universitätsmedizin Berlin
name: Thomas Reinhold, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kass B, Icke K, Witt CM, Reinhold T. Effectiveness and cost-effectiveness of treatment with additional enrollment to a homeopathic integrated care contract in Germany. BMC Health Serv Res. 2020 Sep 15;20(1):872. doi: 10.1186/s12913-020-05706-4.