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

Cystic Fibrosis Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423576
• Other study ID #: VEMSE-CF
• Status: Completed
• Phase: N/A
• First received: January 23, 2018
• Last updated: February 15, 2018
• Start date: August 1, 2011
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2018
• Source: Mukoviszidose Institut gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: December 31, 2016
• Est. primary completion date: February 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• comprehensive patient-centered outpatient health service with multiple components
Individualized multi-component education and counselling program coordinated by a case Manager.

Locations

Country	Name	City	State
Germany	Mukoviszidose Institut	Bonn

Sponsors (8)

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

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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. — View 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. — View 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. — View 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. Review. — View Citation

Ravens-Sieberer U, Otto C, Kriston L, Rothenberger A, Döpfner M, Herpertz-Dahlmann B, Barkmann C, Schön G, Hölling 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. — View 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. — View Citation

Sens B, Stern M. (2012) (Hrsg).Qualitätssicherung Mukoviszidose. Überblick über den Gesundheitszustand der Patienten in Deutschland 2012, Bonn/Hannover

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Delta Proportion of patients with subnormal FEV1	Change in the Proportion of patients with an FEV1<80% predicted	24 months
Other	Delta Proportion of Patients with well preserved BMI	Change in the Proportion of patients with a BMI equal or greater 22 kg/m2 (females) or 23 kg/m2 (males)	24 months
Other	Adherence to therapy	Performance of planned assessments (four per year; eight during intervention)	24 months
Other	Quality of Life (patients)	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)	24 months
Other	Quality of Life (parents)	self-report of parents´ Quality of Life; questionnaire - EY5D; three assessments during intervention(begin / after 12 month /after 24 month)	24 months
Other	Emotional stress (Patients)	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)	24 months
Primary	Number of BMI and FEV1 assessments	crude number of assessments (BMI and FEV1) performed during the study period	24 months
Secondary	Mortality	Number of patients deceased during the study period	24 months
Secondary	Referrals for Lung Transplantation	number of patients referred for lung Transplantation during the study	24 months
Secondary	Delta FEV1	Change in FEV1 from baseline to end of study	24 months
Secondary	Delta BMI	Change in BMI from baseline to end of study	24 months
Secondary	Outpatient visits	Number of outpatient visits during study period	24 months
Secondary	Hospitalizations	number of hospitalizations during the study period	24 months