to study search History

Workability, Health Literacy and Life Quality of Patients with Common Variable Immunodeficiency Disorders

Organizational Data

DRKS-ID:
DRKS00010838
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2016-07-19
Last update in DRKS:
2017-10-12
Registration type:
Prospective

Acronym/abbreviation of the study

WoHL-CVID

URL of the study

No Entry

Brief summary in lay language

Patients with common variable immunodeficiency suffer from an impaired immune system due to reduced antibody production. As a consequence they are often affected by colds, sinusitis, pneumonia and other infections. For a substantial proportion of CVID patients, immunoglobulin substitution can improve these symptoms. However, infection frequency, hospital admissions as well as days absent from work are still elevated among CVID patients compared to healthy individuals. Various studies also reported an impaired quality of life among CVID patients compared to healthy individuals. Little research has been performed to evaluate the impact of the disease on the workability of patients. Therefore, this study will investigate whether reduced workability is a relevant topic among the CVID patient population. In that context we will assess the health literacy of CVID patients as well as other factors with putative impact on their workability as well as their quality of life. Results of this study shall contribute to the development of a program to improve health literacy as well as workability of patients with CVID.

Brief summary in scientific language

Common variable immunodeficiency (CVID) is the most prevalent primary immune deficiency disorder in adults. Because of impaired antibody provision, CVID is linked with recurrently infections of the upper and lower respiratory tract and can lead to restricted lung function, autoimmune diseases, granuloma and cancer. Immunoglobulin substitution leads to a significant improvement of symptoms in the majority of patients. However, an increased susceptibility to viral infections often persists. Overall, the number of infections, hospitalizations or days of absence from work due to this condition is higher in patients with CVID and on average their quality of life is lower than in healthy persons. Until now, little is known about the impact of the disease on patients’ workability. The objective of this exploratory study is to find out if subgroups of CVID patients exist who are characterized by a limited workability and which factors contribute to it. In this context we will assess health literacy and other factors which could have an impact on limited workability and reduced life quality. The results of this study will support the development of a patient program fostering patients with CVID to cope with their disease.

Health condition or problem studied

ICD10:
D83 - Common variable immunodeficiency
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Patients with common variable immunodeficiency (CVID) complete one questionnaire in terms of their workability, quality of life, health literacy, infections and socio-demographic characteristics.

Endpoints

Primary outcome:
Description of the workability of patients with common variable immunodeficiency (CVID) assessed by the patient self-evaluated “Workability Index” (WAI) and by parts of the “Indicators of the Rehabilitation Status” (IRES).
Secondary outcome:
(1) Statistical correlation of workability, quality of life and health literacy. (2) Identification of risk groups of impaired workability. (3) Data generation for the development of a patient program to enhance the health literacy and to foster the workability of patients with CVID.

Study Design

Purpose:
Other
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Centrum für Chronische Immundefizienz (CCI) Freiburg im Breisgau

Recruitment period and number of participants

Planned study start date:
2016-07-21
Actual study start date:
2016-07-25
Planned study completion date:
No Entry
Actual Study Completion Date:
2016-11-18
Target Sample Size:
200
Final Sample Size:
238

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Informed consent available

Exclusion Criteria

(1) Patient with a serious progressive course of disease and short life expectancy. (2) Insufficient comprehension of German language.

Addresses

Primary Sponsor

Universitätsklinikum Freiburg, Centrum für Chronische Immundefizienz (CCI) am Zentrum für Translationale Zellforschung (ZTZ), Clinical Research Unit
PD Dr. Alexandra Nieters M.P.H
Breisacher Str. 115
79106 Freiburg
Germany
Telephone:
49 761 270-78150
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/cci
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum Freiburg, Centrum für Chronische Immundefizienz (CCI) am Zentrum für Translationale Zellforschung (ZTZ), Clinical Research Unit
PD Dr. Alexandra Nieters M.P.H
Breisacher Str. 115
79106 Freiburg
Germany
Telephone:
49 761 270-78150
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/cci

Contact for Public Queries

Universitätsklinikum Freiburg, Centrum für Chronische Immundefizienz (CCI) am Zentrum für Translationale Zellforschung (ZTZ), Clinical Research Unit
PD Dr. Alexandra Nieters M.P.H
Breisacher Str. 115
79106 Freiburg
Germany
Telephone:
49 761 270-78150
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/cci

Principal Investigator

Universitätsklinikum Freiburg, Centrum für Chronische Immundefizienz (CCI) am Zentrum für Translationale Zellforschung (ZTZ), Clinical Research Unit
PD Dr. Alexandra Nieters M.P.H
Breisacher Str. 115
79106 Freiburg
Germany
Telephone:
49 761 270-78150
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/cci

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

BMBF Bundesministerium für Bildung und Forschung
53175 53175 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
+49-761-27072630
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2016-05-10
Ethics committee number:
256/16
Vote of the Ethics Committee:
Approved
Date of the vote:
2016-07-12

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
U1111-1185-3874
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry