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Completed

NCT Number: NCT01854580

Evaluation of an Integrated Care Project

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

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Key information

Conditions

Asthma Allergic Rhinitis Atopic Eczema Behavior Behavioral Symptoms Brain Diseases Bronchial Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Depression Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Headache Headache Disorders Headache Disorders, Primary Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Migraine Migraine Disorders Nervous System Diseases Neurologic Manifestations Nose Diseases Otorhinolaryngologic Diseases Pain Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Health related quality of life (SF-12)

    Time frame: 3, 6 and 12 months

  2. Costs

    Time frame: 3, 6, and 12 months period

  3. Diagnoses-specific patient reported outcomes

    Time frame: 3 and 12 months

    same parameters as for primary outcome, but different time point

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: ediva

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 15, 2013
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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