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

Mukoviszidose Institut gGmbH

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Behavioral: comprehensive patient-centered outpatient health service with multiple components

Study type: Interventional

Funder types: Other

Identifiers

NCT03423576

VEMSE-CF

Details and patient eligibility

About

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.

Enrollment: 318 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

318 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: comprehensive patient-centered outpatient health service with multiple components

Control

No Intervention group

Description:

Standard care