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

Sponsor

Mukoviszidose Institut gGmbH (Other)

Overall Status

Completed

CT.gov ID

NCT03423576

Collaborator

Federal Ministry of Health, Germany (Other), Wuerzburg University Hospital (Other), Hannover Medical School (Other), University Hospital Frankfurt (Other), CF-Center Hamburg-Altona (Other), University Hospital Ulm (Other), Medical Association of Lower Saxony (Ärztekammer Niedersachsen), Germany (Other)

318

Enrollment

Location

Arms

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Behavioral: comprehensive patient-centered outpatient health service with multiple components	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

318 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking Description:

there was no masking of patients or outcome assessors

Primary Purpose:

Health Services Research

Official Title:

Effects of a Comprehensive Patient-centered Health Service With a Focus on Psychosocial Services for Patients With Rare Diseases Using Cystic Fibrosis as an Example (Evaluation Eines Ganzheitlichen Patientenzentrierten Versorgungsmodells für Patienten Mit Seltenen Erkrankungen Unter Besonderer Berücksichtigung Der Psychosozialen Versorgung am Beispiel Mukoviszidose)

Actual Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Feb 28, 2016

Actual Study Completion Date :

Dec 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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.	Behavioral: comprehensive patient-centered outpatient health service with multiple components Individualized multi-component education and counselling program coordinated by a case Manager. Other Names: Intervention
No Intervention: Control Standard care

Arm

Intervention/Treatment

Experimental: Intervention

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.

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

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

Other Names:

Intervention

No Intervention: Control

Standard care

Outcome Measures

Primary Outcome Measures

Number of BMI and FEV1 assessments [24 months]
crude number of assessments (BMI and FEV1) performed during the study period

Secondary Outcome Measures

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
Outpatient visits [24 months]
Number of outpatient visits during study period
Hospitalizations [24 months]
number of hospitalizations during the study period

Other Outcome Measures

Delta Proportion of patients with subnormal FEV1 [24 months]
Change in the Proportion of patients with an FEV1<80% predicted
Delta Proportion of Patients with well preserved BMI [24 months]
Change in the Proportion of patients with a BMI equal or greater 22 kg/m2 (females) or 23 kg/m2 (males)
Adherence to therapy [24 months]
Performance of planned assessments (four per year; eight during intervention)
Quality of Life (patients) [24 months]
Self- or proxy-Report of patients´ Quality of Life: questionnaire - EQ5D (adults) / EQ5D - Y (13-18) / CFQ-R-6-12; three assessments during intervention (begin / after 12 month /after 24 month)
Quality of Life (parents) [24 months]
self-report of parents´ Quality of Life; questionnaire - EY5D; three assessments during intervention(begin / after 12 month /after 24 month)
Emotional stress (Patients) [24 months]
Self- or proxy-Report of patients´ emotional stress; questionnaire - Hospital Anxiety and Depression Scale (HADS); three assessments during Intervention (begin / after 12 month /after 24 month)

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mukoviszidose Institut	Bonn		Germany	53117

Sponsors and Collaborators

Mukoviszidose Institut gGmbH
Federal Ministry of Health, Germany
Wuerzburg University Hospital
Hannover Medical School
University Hospital Frankfurt
CF-Center Hamburg-Altona
University Hospital Ulm
Medical Association of Lower Saxony (Ärztekammer Niedersachsen), Germany

Investigators

Study Chair: Uta Düesberg, Dr., Mukoviszidose Institut gGmbH
Study Director: Miriam Schlangen, Dr., Mukoviszidose Institut gGmbH
Principal Investigator: Lutz Goldbeck, Prof. Dr., Ulm University Hospital
Principal Investigator: Helge Hebestreit, Prof. Dr., Wuerzburg University Hospital