NCT01854580

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,960

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

5.8 years

First QC Date

April 22, 2013

Last Update Submit

February 13, 2019

Conditions

Keywords

Comparative effectiveness researchhealth economic evaluation

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

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

MeSH Terms

Conditions

AsthmaRhinitis, AllergicDermatitis, AtopicMigraine DisordersHeadacheDepression

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Claudia M Witt, MD, MBA

    Charite Universitätsmedizin Berlin

    PRINCIPAL INVESTIGATOR
  • Thomas Reinhold, PhD

    Charite-Universitätsmedizin Berlin

    PRINCIPAL INVESTIGATOR

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

Locations