To answer the following research questions:How is quality of life in patients with adrenal insufficiency?How is cognitive functioning in patients with adrenal insufficiency?Is there a difference in cognitive functioning between patients who did/did…
ID
Source
Brief title
Condition
- Adrenal gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical chart review
12 neuropsychological tests
7 quality of life questionnaires
5 psychopathology/personality questionnaires
Secondary outcome
not applicable
Background summary
Endocrine diseases have important effects on daily and cognitive functioning
and therefore quality of life. These impacts differ between various diseases,
since each hormone has its own effects and each disorder its own treatment
modalities. It is of great importance to study the effects of various endocrine
diseases and their treatments on patient functioning and quality of life and to
anticipate on them during treatment.
Study objective
To answer the following research questions:
How is quality of life in patients with adrenal insufficiency?
How is cognitive functioning in patients with adrenal insufficiency?
Is there a difference in cognitive functioning between patients who did/did not
postpone their hydrocortison dosis?
What is the prevalence of psychopathology and negative personality traits in
patients with adrenal insufficiency?
Study design
Cross-over design study in patients with primary adrenal insufficiency. By
letter, patients will be asked to complete several questionnaires on quality of
life, psychopathology, and personality. We will also encourage them to ask a
person nearby, with the same gender and approximately the same age (max +/-
10yr), to complete the same questionnaires.
Furthermore, patients will also be asked to come to the LUMC for a
neuropsychological screening. Half of the patients will be asked to postpone
their morning dosis hydrocortison on the day of the neuropsychological
screening to after the screening (approximately 3 hours later dan usual), while
the other half of the patients will take their usual morning dosage
hydrocortison before the screening.
After six months, patients will be asked to participate in the
neuropsychological screening again. The group that postponed their morning
doasage hydrocoritson before the first screening will be asked to take their
usual dosage before the screening and vice versa.
Study burden and risks
The neuropsychological screening will take place in the LUMC and takes
approximately 1,5-2h. The questionnaires can be filled out at home (duration
app. 1,5 hours).
Using a cross-over design, half of the patients will be asked to skip a dosis
hydrocoritson. Directly after the neuropsychological screening (1,5-2 hours
later), they can take their dosis.
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
Patients during follow-up for primary adrenal insufficiency
18-70yr
Exclusion criteria
Present or previous drug or alcohol abuse
Previous cerebral problems, like CVA or cerebral trauma
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL31984.058.10 |