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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01854580
Other study ID # 1-Witt
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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