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

NCT03423576 NA COMPLETED

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.

Details

Lead sponsor	Mukoviszidose Institut gGmbH
Phase	NA
Status	COMPLETED
Enrolment	318
Start date	Mon Aug 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Sat Dec 31 2016 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Cystic Fibrosis

Interventions

• comprehensive patient-centered outpatient health service with multiple components

Countries

Germany