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]
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Berlin, 독일, 10117
- Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Diagnosis-specific patient reported outcomes
기간: 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 |
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Health related quality of life (SF-12)
기간: 3, 6 and 12 months
|
3, 6 and 12 months
|
|
|
Costs
기간: 3, 6, and 12 months period
|
3, 6, and 12 months period
|
|
|
Diagnoses-specific patient reported outcomes
기간: 3 and 12 months
|
same parameters as for primary outcome, but different time point
|
3 and 12 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Claudia M Witt, MD, MBA, Charite Universitatsmedizin Berlin
- 수석 연구원: Thomas Reinhold, PhD, Charité-Universitätsmedizin Berlin
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .