Evaluation of an Integrated Care Project

NCT ID: NCT01854580

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3960 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Allergic Rhinitis Atopic Eczema Migraine Headache Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Integrated care

Insured people in the Techniker Krankenkasse that are registered in the integrated care project.

No interventions assigned to this group

Control group

Insured people in the Techniker Krankenkasse that are not registered in the integrated care project.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Claudia M. Witt

Prof. Dr. med, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Claudia M Witt, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Charite Universitätsmedizin Berlin

Thomas Reinhold, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite-Universitätsmedizin Berlin

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32933511 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1-Witt

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Homeogenomic Trial
NCT02018341 WITHDRAWN NA
Effectiveness of Chinese Herbal Therapy for Asthma
NCT00712296 TERMINATED PHASE1/PHASE2
Homeopathic Drug Provings
NCT00809263 WITHDRAWN NA