NCT03423576

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

4.6 years

First QC Date

January 23, 2018

Last Update Submit

February 15, 2018

Conditions

Cystic Fibrosis

Keywords

health servicesFEV1BMIquality of lifemental stress

Outcome Measures

Primary Outcomes (1)

  • Number of BMI and FEV1 assessments

    crude number of assessments (BMI and FEV1) performed during the study period

    24 months

Secondary Outcomes (6)

  • Mortality

    24 months

  • Referrals for Lung Transplantation

    24 months

  • Delta FEV1

    24 months

  • Delta BMI

    24 months

  • Outpatient visits

    24 months

  • +1 more secondary outcomes

Other Outcomes (6)

  • Delta Proportion of patients with subnormal FEV1

    24 months

  • Delta Proportion of Patients with well preserved BMI

    24 months

  • Adherence to therapy

    24 months

  • +3 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Standard care

Interventions

comprehensive patient-centered outpatient health service with multiple componentsBEHAVIORAL

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

Also known as: Intervention
Intervention

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • post lung Transplantation
  • listed for lung Transplantation and planned inpatient stay for more than 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mukoviszidose Institut

Bonn, 53117, Germany

Location

Related 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.

    PMID: 21384564BACKGROUND

  • 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.

    PMID: 20472857BACKGROUND

  • 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.

    PMID: 15752677BACKGROUND

  • 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.

    PMID: 25428179BACKGROUND

  • 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.

    PMID: 20584632BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 18194408BACKGROUND

MeSH Terms

Conditions

Cystic FibrosisStress, Psychological

Interventions

Methods

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Uta Düesberg, Dr.

    Mukoviszidose Institut gGmbH

    STUDY CHAIR

  • Miriam Schlangen, Dr.

    Mukoviszidose Institut gGmbH

    STUDY DIRECTOR

  • Lutz Goldbeck, Prof. Dr.

    Ulm University Hospital

    PRINCIPAL INVESTIGATOR

  • Helge Hebestreit, Prof. Dr.

    Wuerzburg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking Details
there was no masking of patients or outcome assessors
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2018

First Posted

February 6, 2018

Study Start

August 1, 2011

Primary Completion

February 28, 2016

Study Completion

December 31, 2016

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

DE(1)