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

Summary

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.

Conditions

• Cystic Fibrosis

Interventions

BEHAVIORAL

comprehensive patient-centered outpatient health service with multiple components

Individualized multi-component education and counselling program coordinated by a case Manager.

Sponsors & Collaborators

• Federal Ministry of Health, Germany

  collaborator OTHER_GOV

• Wuerzburg University Hospital

  collaborator OTHER

• Hannover Medical School

  collaborator OTHER

• Goethe University

  collaborator OTHER

• CF-Center Hamburg-Altona

  collaborator UNKNOWN

• University Hospital Ulm

  collaborator OTHER

• Medical Association of Lower Saxony (Ärztekammer Niedersachsen), Germany

  collaborator UNKNOWN

• Mukoviszidose Institut gGmbH

  lead OTHER

Principal Investigators

• Uta Düesberg, Dr. · Mukoviszidose Institut gGmbH

• Miriam Schlangen, Dr. · Mukoviszidose Institut gGmbH

• Lutz Goldbeck, Prof. Dr. · Ulm University Hospital

• Helge Hebestreit, Prof. Dr. · Wuerzburg University Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Model

PARALLEL

Eligibility

Min Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-08-01

Primary Completion

2016-02-28

Completion

2016-12-31

Countries

• Germany

Study Locations