To determine the prevalence of pruritus and pemphigoid in nursing home patients.To assess the relationship of demographic and medical risk factors with pemphigoid in nursing home patients.To assess the association between pruritus and…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the prevalence of pruritus and pemphigoid in nursing
home patients.
Presence of pruritus
We will assess pruritus as follows:
Presence and intensity of pruritus will be determined (hetero-)anamnestically.
Intensity will be scored with the Bullous Pemphigoid Disease Area Index (BPDAI)
pruritus score, which is a validated score that covers the grade of intensity
of pruritus with a Visual Analogue Scale (VAS) from 0 (no itch) to 10 (maximum
itch), answering the question *How severe is your itching today/week/month? A
total score is calculated from this out of 30. Additionally, presence and
intensity of pruritus will be determined hetero-anamnestically in all patients
based on the derivative score of the extent of excoriations in the BPDAI
pruritus score. Other present skin lesions will be classified using the ILDS
skin efflorescence classification (e.g. excoriations, blisters, vesicles,
papules, urticarial, erythema), other relevant skin diseases will be registered
from the medical record.
Pemphigoid immune-serology testing
• Indirect IF on monkey esophagus substrate
• Anti-basement membrane zone (BMZ) IgG antibodies: positive/negative
• Indirect IF on human salt-split skin substrate
• IgG antibodies with epidermal side staining of artificial split: positive/
negative
• ELISA BP180 NC16A
• Anti-BP180 NC16A IgG index (cut-off value positive >=9 U/ml)
• ELISA BP230
• Anti-BP230 IgG index (cut-off value positive >=9 U/ml)
• Immunoblot keratinocyte extract
• Presence of circulating IgG antibodies against BP180 (180kDa) or BP230 (230
kDa)
Determination of ANA, anti-SSA, and anti-SSB antibodies will be used as a
standard internal quality control.
Secondary outcome
Secondary explorative parameters are the associations between demographic and
medical risk factors and pemphigoid in nursing home patients, including:
• Age, sex
• Co-morbidities
• Dementia (according to DSM-criteria)
• Cerebrovascular accident
• Parkinson*s disease
• Other neurodegenerative disease
• Neuropsychiatric symptoms: Neuro Psychiatric Inventory - Nursing Home version
(NPI-NH, hetero-anamnestic)
• Activities of Daily Living: Karnofsky Performance Scale
• Medication use (medical file)
Background summary
Pruritus or itch is the most common skin symptom in elderly patients and is
estimated to affect up to 30% of nursing home patients. Clinical and
experimental evidence suggests pruritus in elderly patients may be linked to
pemphigoid. Pemphigoid is the most common autoimmune skin blistering diseases
and mainly affects the elderly. It is successfully treatable with systemic
therapy. However, pemphigoid is often missed as a cause of pruritus in elderly
patients. Although nursing home patients and patients with dementia in
particular have the highest risk for development of pemphigoid, no study has
been performed in this population so far. Including serological screening for
pemphigoid in the diagnostic evaluation of chronic pruritus in nursing home
patients may lead to the diagnosis of pemphigoid. Furthermore, chronic itch may
be an unrecognized cause of neuropsychiatric symptoms in nursing home patients
with dementia.
Study objective
To determine the prevalence of pruritus and pemphigoid in nursing home patients.
To assess the relationship of demographic and medical risk factors with
pemphigoid in nursing home patients.
To assess the association between pruritus and neuropsychiatric symptoms.
Study design
This study is designed as a cross-sectional study. It will be conducted in at
least 3 of the 13 long-term care organisations participating in the UNO-UMCG
network. Assessment of pruritus and registration of co-morbidities,
neuropsychiatric symptoms and medication use will be conducted on these
locations. Laboratory measurements (immune serological testing) will be
conducted by the Dermatological Laboratory at the UMCG.
Study burden and risks
This non-therapeutic observational research concerns elderly nursing home
patients including those with incapacitating (psycho)geriatric disease.
Pruritus and pemphigoid have not been studied before in nursing home patients,
while these patients have the highest risk for development of pemphigoid with
the presence of multiple risk factors, such as high age (mean age 85 years
old), neurological co-morbidities associated with pemphigoid and the use of
psychotropic drugs. This study in elderly nursing home patients may be
beneficial for this group of subjects and cannot be conducted without their
participation. Chronic pruritus may remain unnoticed by caregivers and the
cause of itch is often not determined. Chronic pruritus may be identified as a
possible cause of neuropsychiatric symptoms. This study may have an important
practical implication in general since screening of a blood sample for
pemphigoid may become standard of care for interpreting pruritus in nursing
home patients and screening for pruritus may become part of the standard
work-up for neuropsychiatric symptoms. The study is designed in such a way that
burden and risks for participants are minimized, whereas the study outcome may
lead to relief of those with unnoticed or *incurable* itch and a possible cause
for neuropsychiatric symptoms. The risks associated with participation and
consequently one extra blood sample during the routine venapunction can be
considered negligible and the burden can be considered minimal.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Inpatient of a nursing home
Age >= 65 years
Subjects or their official representatives have signed informed consent
Exclusion criteria
Age < 65 years
Subjects who do not have signed informed consent
Receiving treatment with (any) systemic immunosuppressive agents
Terminally ill patients with a life expectancy of less than 4 weeks
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL56232.042.15 |
| OMON | NL-OMON26576 |