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

Not Applicable

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT03423576
• Lead Sponsor: Mukoviszidose Institut gGmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-01
• Primary Completion: 2016-02-28
• Study Completion: 2016-12-31
• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-30
• Status Verified: 2018-02
• Study First Posted: 2018-02-06
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of BMI and FEV1 assessments	24 months	crude number of assessments (BMI and FEV1) performed during the study period

Secondary Outcome Measures

Name	Time	Method
Outpatient visits	24 months	Number of outpatient visits during study period
Hospitalizations	24 months	number of hospitalizations during the study period
Mortality	24 months	Number of patients deceased during the study period
Referrals for Lung Transplantation	24 months	number of patients referred for lung Transplantation during the study
Delta FEV1	24 months	Change in FEV1 from baseline to end of study
Delta BMI	24 months	Change in BMI from baseline to end of study

Trial Locations

Locations (1)

Mukoviszidose Institut; 🇩🇪 Bonn, Germany