Clinical trial NCT03423576: Effects of a Comprehensive Patient-centered Health Service in Cystic Fibrosis (VEMSE-CF)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: health services
FEV1
BMI
quality of life
mental stress
Lead sponsor: Mukoviszidose Institut gGmbH
Sponsor class: OTHER
Collaborators: name: Federal Ministry of Health, Germany
name: Wuerzburg University Hospital
name: Hannover Medical School
name: Goethe University
name: CF-Center Hamburg-Altona
name: University Hospital Ulm
name: Medical Association of Lower Saxony (Ärztekammer Niedersachsen), Germany
First posted: 2018-02-06
Enrollment: 318
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Number of BMI and FEV1 assessments
timeFrame: 24 months
Secondary outcomes:
measure: Mortality
timeFrame: 24 months
measure: Referrals for Lung Transplantation
timeFrame: 24 months
measure: Delta FEV1
timeFrame: 24 months
measure: Delta BMI
timeFrame: 24 months
measure: Outpatient visits
timeFrame: 24 months
measure: Hospitalizations
timeFrame: 24 months
Other outcomes:
measure: Delta Proportion of patients with subnormal FEV1
timeFrame: 24 months
measure: Delta Proportion of Patients with well preserved BMI
timeFrame: 24 months
measure: Adherence to therapy
timeFrame: 24 months
measure: Quality of Life (patients)
timeFrame: 24 months
measure: Quality of Life (parents)
timeFrame: 24 months
measure: Emotional stress (Patients)
timeFrame: 24 months
Locations:
city: Bonn
country: Germany
facility: Mukoviszidose Institut
Study officials:
affiliation: Mukoviszidose Institut gGmbH
name: Uta Düesberg, Dr.
role: STUDY_CHAIR
affiliation: Mukoviszidose Institut gGmbH
name: Miriam Schlangen, Dr.
role: STUDY_DIRECTOR
affiliation: Ulm University Hospital
name: Lutz Goldbeck, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuerzburg University Hospital
name: Helge Hebestreit, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Besier T, Born A, Henrich G, Hinz A, Quittner AL, Goldbeck L; TIDES Study Group. Anxiety, depression, and life satisfaction in parents caring for children with cystic fibrosis. Pediatr Pulmonol. 2011 Jul;46(7):672-82. doi: 10.1002/ppul.21423. Epub 2011 Mar 7.
citation: Goldbeck L, Besier T, Hinz A, Singer S, Quittner AL; TIDES Group. Prevalence of symptoms of anxiety and depression in German patients with cystic fibrosis. Chest. 2010 Oct;138(4):929-36. doi: 10.1378/chest.09-2940. Epub 2010 May 14.
citation: Kerem E, Conway S, Elborn S, Heijerman H; Consensus Committee. Standards of care for patients with cystic fibrosis: a European consensus. J Cyst Fibros. 2005 Mar;4(1):7-26. doi: 10.1016/j.jcf.2004.12.002. No abstract available.
citation: Ravens-Sieberer U, Otto C, Kriston L, Rothenberger A, Dopfner M, Herpertz-Dahlmann B, Barkmann C, Schon G, Holling H, Schulte-Markwort M, Klasen F; BELLA study group. The longitudinal BELLA study: design, methods and first results on the course of mental health problems. Eur Child Adolesc Psychiatry. 2015 Jun;24(6):651-63. doi: 10.1007/s00787-014-0638-4. Epub 2014 Nov 27.
citation: Ruf K, Winkler B, Hebestreit A, Gruber W, Hebestreit H. Risks associated with exercise testing and sports participation in cystic fibrosis. J Cyst Fibros. 2010 Sep;9(5):339-45. doi: 10.1016/j.jcf.2010.05.006. Epub 2010 Jul 2.
citation: Sens B, Stern M. (2012) (Hrsg).Qualitätssicherung Mukoviszidose. Überblick über den Gesundheitszustand der Patienten in Deutschland 2012, Bonn/Hannover
citation: Graf von der Schulenburg JM, Greiner W, Jost F, Klusen N, Kubin M, Leidl R, Mittendorf T, Rebscher H, Schoeffski O, Vauth C, Volmer T, Wahler S, Wasem J, Weber C; Hanover Consensus Group. German recommendations on health economic evaluation: third and updated version of the Hanover Consensus. Value Health. 2008 Jul-Aug;11(4):539-44. doi: 10.1111/j.1524-4733.2007.00301.x. Epub 2008 Jan 11. No abstract available.