Cystic FibrosisVEMSE-CFNCT03423576
Effects of a Comprehensive Patient-centered Health Service in Cystic Fibrosis (VEMSE-CF)
A study testing comprehensive patient-centered outpatient health service with multiple components in people with Cystic Fibrosis, run by Mukoviszidose Institut gGmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- comprehensive patient-centered outpatient health service with multiple components
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2011to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- post lung Transplantation
- listed for lung Transplantation and planned inpatient stay for more than 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Cystic Fibrosis
- Being tested
- comprehensive patient-centered outpatient health service with multiple components
- Keywords
- health services, FEV1, BMI, quality of life, mental stress
- Medical subject headings
- Cystic Fibrosis, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive patient-centered outpatient health service with multiple componentsBehavioural
Also called Intervention
Individualized multi-component education and counselling program coordinated by a case Manager.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: comprehensive patient-centered outpatient health service with multiple components |
| Control | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of BMI and FEV1 assessments
crude number of assessments (BMI and FEV1) performed during the study period
Measured: 24 months
Secondary outcomes (6)
Mortality
Number of patients deceased during the study period
Measured: 24 months
Referrals for Lung Transplantation
number of patients referred for lung Transplantation during the study
Measured: 24 months
Delta FEV1
Change in FEV1 from baseline to end of study
Measured: 24 months
Delta BMI
Change in BMI from baseline to end of study
Measured: 24 months
Outpatient visits
Number of outpatient visits during study period
Measured: 24 months
Hospitalizations
number of hospitalizations during the study period
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start1 Aug 2011
- Primary completion28 Feb 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mukoviszidose Institut gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Ministry of Health, Germany, Wuerzburg University Hospital, Hannover Medical School, Goethe University, CF-Center Hamburg-Altona, University Hospital Ulm, Medical Association of Lower Saxony (Ärztekammer Niedersachsen), Germany
- Responsible party
- Sponsor
- Investigators
- Uta Düesberg, Dr., Study chair, Mukoviszidose Institut gGmbHMiriam Schlangen, Dr., Study director, Mukoviszidose Institut gGmbHLutz Goldbeck, Prof. Dr., Principal investigator, Ulm University HospitalHelge Hebestreit, Prof. Dr., Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423576
- Sponsor's protocol ID
- VEMSE-CF
- Acronym
- VEMSE-CF
- Status last verified
- Feb 2018
- First submitted
- 23 Jan 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21384564Goldbeck 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.
PubMed 20472857Kerem 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.
PubMed 15752677Ravens-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.
PubMed 25428179Ruf 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.
PubMed 20584632Sens B, Stern M. (2012) (Hrsg).Qualitätssicherung Mukoviszidose. Überblick über den Gesundheitszustand der Patienten in Deutschland 2012, Bonn/Hannover
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.
PubMed 18194408
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03423576
- Acronym / sponsor ID
- VEMSE-CF / VEMSE-CF
- Conditions
- Cystic Fibrosis
- Keywords
- health services, FEV1, BMI, quality of life, mental stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Mukoviszidose Institut gGmbHUniversity, hospital or other
- Collaborators
- Federal Ministry of Health, Germany, Wuerzburg University Hospital, Hannover Medical School, Goethe University, CF-Center Hamburg-Altona, University Hospital Ulm, Medical Association of Lower Saxony (Ärztekammer Niedersachsen), Germany
- Study start
- 1 Aug 2011 (actual)
- Primary completion
- 28 Feb 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: comprehensive patient-centered outpatient health service with multiple componentscomprehensive 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. |
| Control | No intervention | –Standard care |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- post lung Transplantation
- listed for lung Transplantation and planned inpatient stay for more than 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comprehensive patient-centered outpatient health service with multiple componentsAlso: InterventionIndividualized multi-component education and counselling program coordinated by a case Manager. | Behavioural | Intervention |
Primary outcome
Number of BMI and FEV1 assessments
Time frame: 24 months
crude number of assessments (BMI and FEV1) performed during the study period
6 secondary outcomes
Mortality
Time frame: 24 months
Referrals for Lung Transplantation
Time frame: 24 months
Delta FEV1
Time frame: 24 months
Delta BMI
Time frame: 24 months
Outpatient visits
Time frame: 24 months
Hospitalizations
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Background: PubMed 21384564Besier 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.
- Background: PubMed 20472857Goldbeck 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.
- Background: PubMed 15752677Kerem 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.
- Background: PubMed 25428179Ravens-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.
- Background: PubMed 20584632Ruf 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.
- BackgroundSens B, Stern M. (2012) (Hrsg).Qualitätssicherung Mukoviszidose. Überblick über den Gesundheitszustand der Patienten in Deutschland 2012, Bonn/Hannover
- Background: PubMed 18194408Graf 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uta Düesberg, Dr. study chair
Mukoviszidose Institut gGmbH
Miriam Schlangen, Dr. study director
Mukoviszidose Institut gGmbH
Lutz Goldbeck, Prof. Dr. principal investigator
Ulm University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comprehensive patient-centered outpatient health service with multiple components in people with Cystic Fibrosis, run by Mukoviszidose Institut gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of BMI and FEV1 assessments (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03423576, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.