Evaluation of an Integrated Care Project (ediva)
Evaluation of an Integrated Care Project of the Statutory Health Insurance Techniker Krankenkasse [Evaluation Des Integrierten Versorgungsangebots Der Techniker Krankenkasse]
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Berlin、ドイツ、10117
- Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Integrated care
Insured people in the Techniker Krankenkasse that are registered in the integrated care project.
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Control group
Insured people in the Techniker Krankenkasse that are not registered in the integrated care project.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Diagnosis-specific patient reported outcomes
時間枠:6 months
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Health related quality of life (SF-12)
時間枠:3, 6 and 12 months
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3, 6 and 12 months
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Costs
時間枠:3, 6, and 12 months period
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3, 6, and 12 months period
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Diagnoses-specific patient reported outcomes
時間枠:3 and 12 months
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same parameters as for primary outcome, but different time point
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3 and 12 months
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協力者と研究者
捜査官
- 主任研究者:Claudia M Witt, MD, MBA、Charite Universitatsmedizin Berlin
- 主任研究者:Thomas Reinhold, PhD、Charité-Universitätsmedizin Berlin
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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