the first objective of this study is to quantify the impact of chronic Q-fever or QFS on work status and psychosocial functioning. Secondly, we will identify factors that are associated with these limitations, to determine which subgroups of…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters will be the summary scores on work status and
psychosocial functioning, measured with several questionnaires (e.g. the
Nijmegen Clinical Screening Instrument, SF-36, Work Ability Index and the
Maudsley Marital Questionnaire).
Secondary outcome
Various validated questionnaires will be used to measure possible mediating
factors, baseline values and/or confounders, such as: fatgue, cognitive
functioning, illness perception, age, gender, education level, health and
disease related parameters and co-morbidity.
Background summary
After the largest outbreak of Q-fever to date between 2007 and 2011, many
infected persons in the Netherlands struggle with the effects from chronic
Q-fever and Q-fever fatigue syndrome (QFS). These diseases have a major impact
on the quality of life, work status and psychosocial functioning of patients.
However, the long term problems for chronic Q-fever and QFS patients have never
been studied in detail.
Study objective
the first objective of this study is to quantify the impact of chronic Q-fever
or QFS on work status and psychosocial functioning.
Secondly, we will identify factors that are associated with these limitations,
to determine which subgroups of patients are mainly affected by these
limitations.
Thirdly, to examine which part of the limitations may be attributed to the
Q-fever infection, work status and psychosocial functioning will be compared to
reference groups.
Finally, we will perform a pilot study to quantify the activity pattern and
level of concentration and memory of chronic Q-fever and QFS patients.
Study design
observational, cross-sectional study with self-administered, computer-based or
paper questionnaires. We will use descriptive analyses for baseline data and
multiple linear regression models to determine the relation between chronic
Q-fever/QFS and long term work status and psychosocial functioning.
Study burden and risks
Participants will fill in a questionnaire once, which will be a combination of
several instruments. Overlapping subscales will be deleted from the
questionnaire, in order to minimize its length.
Geert Grooteplein Noord 21
Nijmegen 6525GA
NL
Geert Grooteplein Noord 21
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Patients meeting the criteria of proven or probable chronic Q-fever according to the Dutch consensus guidelines on chronic Q-fever diagnostics and diagnosed after the Q-fever outbreak of 2007 are eligible for this study.;Patients with QFS are diagnosed according to the following criteria:
- Fatigue persisting longer than 6 months
- Laboratory-confirmed acute Q-fever
- no recent (<3 months ago) chronic Q-fever diagnosis (as described in the previous paragraph)
- no somatic or psychiatric co-morbidity, which could explain the symptoms
- fatigue causes significant limitations in daily life (work or home)
- fatigue symptoms were not present prior to the acute Q-fever infection or since then clearly increased in severity (so-called *knikmoment* or turning point);We will only include the partner of the patients, if the patient has indicated to be married, have a registered partnership or is living together with their partner. ;Patients with diabetes will be included if they have received their diagnosis around 5 to 10 years ago, and are comparable with the Q-fever group in age and gender.
Exclusion criteria
Patients diagnosed with a possible chronic Q-fever are not eligible for participation in this study, as the majority of these patients ultimately appear not to have chronic Q-fever.;Patients with diabetes and persons in the reference group from the general population will be excluded if they have had a positive Q-fever diagnosis at any time in their life, including no diagnosis of chronic Q-fever or QFS.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55961.091.15 |