Evaluation of an Integrated Care Project
ediva
1 other identifier
observational
3,960
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 22, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFebruary 15, 2019
February 1, 2019
5.8 years
April 22, 2013
February 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Health related quality of life (SF-12)
3, 6 and 12 months
Costs
3, 6, and 12 months period
Diagnoses-specific patient reported outcomes
3 and 12 months
Study Arms (2)
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.
Eligibility Criteria
Insured people of the statutory health insurance Techniker Krankenkasse in Germany
You may qualify if:
- 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
You may not qualify if:
- Participation in a disease-management program
- Participation in an intervention study
- Cancer diagnosis
- current usage of a complementary therapy (control group only)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin
Berlin, 10117, Germany
Related Publications (1)
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.
PMID: 32933511DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudia M Witt, MD, MBA
Charite Universitätsmedizin Berlin
- PRINCIPAL INVESTIGATOR
Thomas Reinhold, PhD
Charite-Universitätsmedizin Berlin
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med, MBA
Study Record Dates
First Submitted
April 22, 2013
First Posted
May 15, 2013
Study Start
March 1, 2013
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
February 15, 2019
Record last verified: 2019-02