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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: comprehensive patient-centered outpatient health service with multiple components


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Individualized multi-component education and counselling program coordinated by a case Manager.<br>* Other names: Intervention;|
| No Intervention: Control<br>Standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of BMI and FEV1 assessments | crude number of assessments (BMI and FEV1) performed during the study period | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Number of patients deceased during the study period | 24 months | 
| Referrals for Lung Transplantation | number of patients referred for lung Transplantation during the study | 24 months | 
| Delta FEV1 | Change in FEV1 from baseline to end of study | 24 months | 
| Delta BMI | Change in BMI from baseline to end of study | 24 months | 
| Outpatient visits | Number of outpatient visits during study period | 24 months | 
| Hospitalizations | number of hospitalizations during the study period | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health services, FEV1, BMI, quality of life, mental stress