search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Pruritus and pemphigoid in nursing home patients


- candidate number24439
- NTR NumberNTR5843
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jun-2016
- Secondary IDsNL56232.042.15 
- Public TitlePruritus and pemphigoid in nursing home patients
- Scientific TitlePruritus and pemphigoid in nursing home patients
- ACRONYMSSENIOR
- hypothesisPruritus or itch is the most common skin symptom in elderly patients and is estimated to affect more than 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.
- Healt Condition(s) or Problem(s) studiedItch, Older adults, Elderly living in resdidential homes for the elderly
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Inpatient of a nursing home (UNO-UMCG)
- Age ≥ 65 years
- Subjects or their official representatives have signed informed consent
- Exclusion criteriaExclusion criteria are:
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-jun-2016
- planned closingdate31-dec-2016
- Target number of participants126
- InterventionsIntervention not applicable.
Invasive procedure: one extra 10mL blood sample will be taken during a routine venapunction
- Primary outcome- Presence and intensity of pruritus:
Intensity will be scored with the Bullous Pemphigoid Disease Area Index (BPDAI) pruritus score, which is a Visual Analogue Scale (VAS) from 0 (no itch) to 10 (maximum itch). 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 immunoserology:
- Indirect IF on monkey esophagus substrate: anti-basement membrane zone (BMZ) IgG antibodies
- 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)
- Secondary outcome- Age, sex
- Co-morbidities
- Dementia (according to DSM IV-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)
- TimepointsCross-sectional
- Trial web siteNA
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Joost M. Meijer
- CONTACT for SCIENTIFIC QUERIES Joost M. Meijer
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryHypothesis: Pruritus or itch is the most common skin symptom in elderly patients and is estimated to affect more than 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.

Objective: to determine the prevalence of pruritus and pemphigoid in nursing home patients.

Study design: cross-sectional study.

Study population: nursing home patients aged 65 years or above, living in a nursing home of one of the long-term care organisations participating in the Universitair Netwerk Ouderenzorg (UNO-UMCG).

Invasive procedure: one extra blood sample of 10 ml will be taken for immune serological testing during a routine venapunction.

Main study parameters/endpoints: the main study outcome is the prevalence of pruritus and pemphigoid in nursing home patients. Intensity of pruritus is scored with the BPDAI pruritus score and a derivative score of skin excoriations. Secondary outcomes are the relationships of demographic factors and medical risk factors with pemphigoid, including dementia and neuropsychiatric symptoms, medication use and Karnofsky activity of daily living score.
- Main changes (audit trail)
- RECORD3-jun-2016 - 28-jun-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl