Effects of a Comprehensive Patient-centered Health Service in Cystic Fibrosis (VEMSE-CF) (VEMSE-CF)

Effects of a Comprehensive Patient-centered Health Service With a Focus on Psychosocial Services for Patients With Rare Diseases Using Cystic Fibrosis as an Example (Evaluation Eines Ganzheitlichen Patientenzentrierten Versorgungsmodells für Patienten Mit Seltenen Erkrankungen Unter Besonderer Berücksichtigung Der Psychosozialen Versorgung am Beispiel Mukoviszidose)

Federal Ministry of Health, Germany, Wuerzburg University Hospital, Hannover Medical School, Goethe University, CF-Center Hamburg-Altona, University Hospital Ulm, Medical Association of Lower Saxony (Ärztekammer Niedersachsen), Germany

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.

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.

Change in the Proportion of patients with a BMI equal or greater 22 kg/m2 (females) or 23 kg/m2 (males)

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)

self-report of parents´ Quality of Life; questionnaire - EY5D; three assessments during intervention(begin / after 12 month /after 24 month)

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)

Inclusion Criteria: confirmed diagnosis of Cystic Fibrosis - written informed consent intervention group: care in one of the 3 CF-centers control group: care in one of the 13 control CF-centers Exclusion Criteria: post lung Transplantation listed for lung Transplantation and planned inpatient stay for more than 4 weeks

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