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| Name | Class |
|---|---|
| Federal Ministry of Health, Germany | OTHER_GOV |
| Wuerzburg University Hospital | OTHER |
| Hannover Medical School | OTHER |
| Goethe University |
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For the Project VEMSE-CF, a comprehensive patient-centered outpatient health service model was developed offering focused interventions in different areas. These included patient education, as well as nutritional and exercise counselling. Special emphasis was given to the psycho-social services. The implementation was supported by a case manager. The model was implemented in three German CF-Centers. For evaluation, Patient data from 13 additional German CF-Centers offering standard care was used as comparison. In total, 153 patients in the Intervention Group and 163 control patients aged 5-52 years contributed data. The primary endpoint was the number of BMI- and FEV1-measurements over 24 months. Secondary endpoints included mortality, lung transplantation, FEV1, BMI, adherence to therapy, Quality of life, and mental stress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | comprehensive patient-centered outpatient health service with multiple components. These components included the addition of a case-manager, structured interventions to improve patient education and adherence to therapy, psychological counselling, social services, and exercise advice. For each Patient, relevant components were identified and a written Intervention plan was negotiated and signed. |
|
| Control | No Intervention | Standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comprehensive patient-centered outpatient health service with multiple components | Behavioral | Individualized multi-component education and counselling program coordinated by a case Manager. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of BMI and FEV1 assessments | crude number of assessments (BMI and FEV1) performed during the study period | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Number of patients deceased during the study period | 24 months |
| Referrals for Lung Transplantation | number of patients referred for lung Transplantation during the study |
| Measure | Description | Time Frame |
|---|---|---|
| Delta Proportion of patients with subnormal FEV1 | Change in the Proportion of patients with an FEV1<80% predicted | 24 months |
| Delta Proportion of Patients with well preserved BMI | Change in the Proportion of patients with a BMI equal or greater 22 kg/m2 (females) or 23 kg/m2 (males) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uta Düesberg, Dr. | Mukoviszidose Institut gGmbH | Study Chair |
| Miriam Schlangen, Dr. | Mukoviszidose Institut gGmbH | Study Director |
| Lutz Goldbeck, Prof. Dr. | Ulm University Hospital | Principal Investigator |
| Helge Hebestreit, Prof. Dr. | Wuerzburg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mukoviszidose Institut | Bonn | 53117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21384564 | Background | Besier T, Born A, Henrich G, Hinz A, Quittner AL, Goldbeck L; TIDES Study Group. Anxiety, depression, and life satisfaction in parents caring for children with cystic fibrosis. Pediatr Pulmonol. 2011 Jul;46(7):672-82. doi: 10.1002/ppul.21423. Epub 2011 Mar 7. | |
| 20472857 | Background | Goldbeck L, Besier T, Hinz A, Singer S, Quittner AL; TIDES Group. Prevalence of symptoms of anxiety and depression in German patients with cystic fibrosis. Chest. 2010 Oct;138(4):929-36. doi: 10.1378/chest.09-2940. Epub 2010 May 14. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| OTHER |
| CF-Center Hamburg-Altona | UNKNOWN |
| University Hospital Ulm | OTHER |
| Medical Association of Lower Saxony (Ärztekammer Niedersachsen), Germany | UNKNOWN |
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there was no masking of patients or outcome assessors
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|
| 24 months |
| Delta FEV1 | Change in FEV1 from baseline to end of study | 24 months |
| Delta BMI | Change in BMI from baseline to end of study | 24 months |
| Outpatient visits | Number of outpatient visits during study period | 24 months |
| Hospitalizations | number of hospitalizations during the study period | 24 months |
| 24 months |
| Adherence to therapy | Performance of planned assessments (four per year; eight during intervention) | 24 months |
| Quality of Life (patients) | Self- or proxy-Report of patients´ Quality of Life: questionnaire - EQ5D (adults) / EQ5D - Y (13-18) / CFQ-R-6-12; three assessments during intervention (begin / after 12 month /after 24 month) | 24 months |
| Quality of Life (parents) | self-report of parents´ Quality of Life; questionnaire - EY5D; three assessments during intervention(begin / after 12 month /after 24 month) | 24 months |
| Emotional stress (Patients) | Self- or proxy-Report of patients´ emotional stress; questionnaire - Hospital Anxiety and Depression Scale (HADS); three assessments during Intervention (begin / after 12 month /after 24 month) | 24 months |
| 15752677 | Background | Kerem E, Conway S, Elborn S, Heijerman H; Consensus Committee. Standards of care for patients with cystic fibrosis: a European consensus. J Cyst Fibros. 2005 Mar;4(1):7-26. doi: 10.1016/j.jcf.2004.12.002. No abstract available. |
| 25428179 | Background | Ravens-Sieberer U, Otto C, Kriston L, Rothenberger A, Dopfner M, Herpertz-Dahlmann B, Barkmann C, Schon G, Holling H, Schulte-Markwort M, Klasen F; BELLA study group. The longitudinal BELLA study: design, methods and first results on the course of mental health problems. Eur Child Adolesc Psychiatry. 2015 Jun;24(6):651-63. doi: 10.1007/s00787-014-0638-4. Epub 2014 Nov 27. |
| 20584632 | Background | Ruf K, Winkler B, Hebestreit A, Gruber W, Hebestreit H. Risks associated with exercise testing and sports participation in cystic fibrosis. J Cyst Fibros. 2010 Sep;9(5):339-45. doi: 10.1016/j.jcf.2010.05.006. Epub 2010 Jul 2. |
| Background | Sens B, Stern M. (2012) (Hrsg).Qualitätssicherung Mukoviszidose. Überblick über den Gesundheitszustand der Patienten in Deutschland 2012, Bonn/Hannover |
| 18194408 | Background | Graf von der Schulenburg JM, Greiner W, Jost F, Klusen N, Kubin M, Leidl R, Mittendorf T, Rebscher H, Schoeffski O, Vauth C, Volmer T, Wahler S, Wasem J, Weber C; Hanover Consensus Group. German recommendations on health economic evaluation: third and updated version of the Hanover Consensus. Value Health. 2008 Jul-Aug;11(4):539-44. doi: 10.1111/j.1524-4733.2007.00301.x. Epub 2008 Jan 11. No abstract available. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |