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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Enrollment
318
Individualized multi-component education and counselling program coordinated by a case Manager.
Mukoviszidose Institut
Bonn, Germany
Number of BMI and FEV1 assessments
crude number of assessments (BMI and FEV1) performed during the study period
Time frame: 24 months
Mortality
Number of patients deceased during the study period
Time frame: 24 months
Referrals for Lung Transplantation
number of patients referred for lung Transplantation during the study
Time frame: 24 months
Delta FEV1
Change in FEV1 from baseline to end of study
Time frame: 24 months
Delta BMI
Change in BMI from baseline to end of study
Time frame: 24 months
Outpatient visits
Number of outpatient visits during study period
Time frame: 24 months
Hospitalizations
number of hospitalizations during the study period
Time frame: 24 months
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