Evaluation of an Integrated Care Project

Overview

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 Title of Study: “Evaluation of an Integrated Care Project of the Statutory Health Insurance Techniker Krankenkasse [Evaluation Des Integrierten Versorgungsangebots Der Techniker Krankenkasse]”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2018

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.

Arms, Groups and Cohorts

  • Integrated care
    • Insured people in the Techniker Krankenkasse that are registered in the integrated care project.
  • Control group
    • Insured people in the Techniker Krankenkasse that are not registered in the integrated care project.

Clinical Trial Outcome Measures

Primary Measures

  • Diagnosis-specific patient reported outcomes
    • Time Frame: 6 months
    • 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

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Charite University, Berlin, Germany
  • Provider of Information About this Clinical Study
    • Principal Investigator: Claudia M. Witt, Prof. Dr. med, MBA – Charite University, Berlin, Germany
  • Overall Official(s)
    • Claudia M Witt, MD, MBA, Principal Investigator, Charite Universitätsmedizin Berlin
    • Thomas Reinhold, PhD, Principal Investigator, Charite-Universitätsmedizin Berlin

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