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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03423576
Recruitment Status : Completed
First Posted : February 6, 2018
Last Update Posted : February 19, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Mukoviszidose Institut gGmbH

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 318 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking:
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 : August 1, 2011
Actual Primary Completion Date : February 28, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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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 Name: Intervention
No Intervention: Control
Standard care


Outcome Measures
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Primary Outcome Measures :
  1. Number of BMI and FEV1 assessments [ Time Frame: 24 months ]
    crude number of assessments (BMI and FEV1) performed during the study period


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 24 months ]
    Number of patients deceased during the study period

  2. Referrals for Lung Transplantation [ Time Frame: 24 months ]
    number of patients referred for lung Transplantation during the study

  3. Delta FEV1 [ Time Frame: 24 months ]
    Change in FEV1 from baseline to end of study

  4. Delta BMI [ Time Frame: 24 months ]
    Change in BMI from baseline to end of study

  5. Outpatient visits [ Time Frame: 24 months ]
    Number of outpatient visits during study period

  6. Hospitalizations [ Time Frame: 24 months ]
    number of hospitalizations during the study period


Other Outcome Measures:
  1. Delta Proportion of patients with subnormal FEV1 [ Time Frame: 24 months ]
    Change in the Proportion of patients with an FEV1<80% predicted

  2. Delta Proportion of Patients with well preserved BMI [ Time Frame: 24 months ]
    Change in the Proportion of patients with a BMI equal or greater 22 kg/m2 (females) or 23 kg/m2 (males)

  3. Adherence to therapy [ Time Frame: 24 months ]
    Performance of planned assessments (four per year; eight during intervention)

  4. Quality of Life (patients) [ Time Frame: 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)

  5. Quality of Life (parents) [ Time Frame: 24 months ]
    self-report of parents´ Quality of Life; questionnaire - EY5D; three assessments during intervention(begin / after 12 month /after 24 month)

  6. Emotional stress (Patients) [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423576


Locations
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Germany
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
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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
More Information
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Publications:
Sens B, Stern M. (2012) (Hrsg).Qualitätssicherung Mukoviszidose. Überblick über den Gesundheitszustand der Patienten in Deutschland 2012, Bonn/Hannover

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Responsible Party: Mukoviszidose Institut gGmbH
ClinicalTrials.gov Identifier: NCT03423576    
Other Study ID Numbers: VEMSE-CF
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mukoviszidose Institut gGmbH:
health services
FEV1
BMI
quality of life
mental stress
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases