Cystic Fibrosis
Conditions
Keywords
health services, FEV1, BMI, quality of life, mental stress
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.
Interventions
BEHAVIORALcomprehensive patient-centered outpatient health service with multiple components
Individualized multi-component education and counselling program coordinated by a case Manager.
Sponsors
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
Mukoviszidose Institut gGmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking description
there was no masking of patients or outcome assessors
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of BMI and FEV1 assessments | 24 months | crude number of assessments (BMI and FEV1) performed during the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 24 months | Number of patients deceased during the study period |
| Referrals for Lung Transplantation | 24 months | number of patients referred for lung Transplantation during the study |
| Delta FEV1 | 24 months | Change in FEV1 from baseline to end of study |
| Delta BMI | 24 months | Change in BMI from baseline to end of study |
| Outpatient visits | 24 months | Number of outpatient visits during study period |
| Hospitalizations | 24 months | number of hospitalizations during the study period |
Other
| Measure | Time frame | Description |
|---|---|---|
| Delta Proportion of Patients with well preserved BMI | 24 months | Change in the Proportion of patients with a BMI equal or greater 22 kg/m2 (females) or 23 kg/m2 (males) |
| Adherence to therapy | 24 months | Performance of planned assessments (four per year; eight during intervention) |
| Quality of Life (patients) | 24 months | 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) |
| Quality of Life (parents) | 24 months | self-report of parents´ Quality of Life; questionnaire - EY5D; three assessments during intervention(begin / after 12 month /after 24 month) |
| Emotional stress (Patients) | 24 months | 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) |
| Delta Proportion of patients with subnormal FEV1 | 24 months | Change in the Proportion of patients with an FEV1\<80% predicted |
Countries
Germany
Outcome results
None listed