AsthmaedivaNCT01854580
Evaluation of an Integrated Care Project
An observational study of Asthma and Allergic Rhinitis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma, Allergic Rhinitis, Atopic Eczema
- How many people
- 3,960 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Insured people of the statutory health insurance Techniker Krankenkasse in Germany
Who may be able to join
- 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
Who cannot join
- Participation in a disease-management program
- Participation in an intervention study
- Cancer diagnosis
- current usage of a complementary therapy (control group only)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin
Berlin, 10117
About this study
Official title: Evaluation of an Integrated Care Project of the Statutory Health Insurance Techniker Krankenkasse [Evaluation Des Integrierten Versorgungsangebots Der Techniker Krankenkasse]
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
Read the 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.
- Conditions
- Asthma, Allergic Rhinitis, Atopic Eczema, Migraine, Headache, Depression
- Keywords
- Comparative effectiveness research, health economic evaluation
- Medical subject headings
- Asthma, Rhinitis, Allergic, Dermatitis, Atopic, Migraine Disorders, Headache, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
Health related quality of life (SF-12)
Measured: 3, 6 and 12 months
Costs
Measured: 3, 6, and 12 months period
Diagnoses-specific patient reported outcomes
same parameters as for primary outcome, but different time point
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startMar 2013
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,960 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia M. Witt, Charite University, Berlin, Germany
- Investigators
- Claudia M Witt, MD, MBA, Principal investigator, Charite Universitätsmedizin BerlinThomas Reinhold, PhD, Principal investigator, Charite-Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854580
- Sponsor's protocol ID
- 1-Witt
- Acronym
- ediva
- Status last verified
- Feb 2019
- First submitted
- 22 Apr 2013
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32933511
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Integrated Care Project of the Statutory Health Insurance Techniker Krankenkasse [Evaluation Des Integrierten Versorgungsangebots Der Techniker Krankenkasse]
- ClinicalTrials.gov ID
- NCT01854580
- Acronym / sponsor ID
- ediva / 1-Witt
- Conditions
- Asthma, Allergic Rhinitis, Atopic Eczema, Migraine, Headache, Depression
- Keywords
- Comparative effectiveness research, health economic evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,960 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Insured people of the statutory health insurance Techniker Krankenkasse in Germany
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Participation in a disease-management program
- Participation in an intervention study
- Cancer diagnosis
- current usage of a complementary therapy (control group only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 32933511Kass 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia M Witt, MD, MBA principal investigator
Charite Universitätsmedizin Berlin
Thomas Reinhold, PhD principal investigator
Charite-Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Allergic Rhinitis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis-specific patient reported outcomes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01854580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.