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Completed

NCT Number: NCT03423576

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

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.

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Key information

Conditions

Cystic Fibrosis Behavior Behavioral Symptoms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases Stress, Psychological

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mukoviszidose Institut

Bonn, 53117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

comprehensive patient-centered outpatient health service with multiple components

Behavioral

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

Other names: Intervention

Primary outcomes

  1. Number of BMI and FEV1 assessments

    Time frame: 24 months

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

Secondary outcomes

  1. Mortality

    Time frame: 24 months

    Number of patients deceased during the study period

  2. Referrals for Lung Transplantation

    Time frame: 24 months

    number of patients referred for lung Transplantation during the study

  3. Delta FEV1

    Time frame: 24 months

    Change in FEV1 from baseline to end of study

  4. Delta BMI

    Time frame: 24 months

    Change in BMI from baseline to end of study

  5. Outpatient visits

    Time frame: 24 months

    Number of outpatient visits during study period

  6. Hospitalizations

    Time frame: 24 months

    number of hospitalizations during the study period

Other outcomes

  1. Delta Proportion of patients with subnormal FEV1

    Time frame: 24 months

    Change in the Proportion of patients with an FEV1<80% predicted

  2. Delta Proportion of Patients with well preserved BMI

    Time frame: 24 months

    Change in the Proportion of patients with a BMI equal or greater 22 kg/m2 (females) or 23 kg/m2 (males)

  3. Adherence to therapy

    Time frame: 24 months

    Performance of planned assessments (four per year; eight during intervention)

  4. Quality of Life (patients)

    Time frame: 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)

  5. Quality of Life (parents)

    Time frame: 24 months

    self-report of parents´ Quality of Life; questionnaire - EY5D; three assessments during intervention(begin / after 12 month /after 24 month)

  6. Emotional stress (Patients)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Mukoviszidose Institut gGmbH

Other

Collaborators

  • CF-Center Hamburg-Altona
  • Federal Ministry of Health, Germany
  • Goethe University
  • Hannover Medical School
  • Medical Association of Lower Saxony (Ärztekammer Niedersachsen), Germany
  • University Hospital Ulm
  • Wuerzburg University Hospital

Registry information

Official study 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)

Acronym: VEMSE-CF

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Feb 6, 2018
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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