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| ID | Type | Description | Link |
|---|---|---|---|
| METc 2015/605 | Other Identifier | Medical Ethical Committee UMCG | |
| NTR5843 | Registry Identifier | Nederlands Trial Register |
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The primary objective of this observational study is to describe the prevalence of pruritus and pemphigoid in nursing home patients. Secondary outcomes are the relationships of demographic factors and medical risk factors with pemphigoid, including dementia and neuropsychiatric symptoms, medication use and Karnofsky score.
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 (nonbullous cutaneous pemphigoid). 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nursing home patients | Nursing home patients aged 65 years or above. One extra blood sample of 10 ml will be taken during a routine venapunction for immunoserology testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Other | One extra blood sample of 10 ml will be taken during a routine venapunction for immunoserology testing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of pruritus | Presence and intensity of pruritus will be determined (hetero-)anamnestically with the Bullous Pemphigoid Disease Area Index (BPDAI) VAS score and derivative score for all subjects. | Day 1 |
| Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence on 1M salt-split human skin substrate | IgG autoantibodies with epidermal side staining of artificial split; positive/negative, staining intensity IgG 1+,2+,3+ | Day 1 |
| Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence microscopy on monkey esophagus substrate | Anti-basement membrane zone IgG autoantibodies; positive/negative, staining intensity IgG 1+,2+,3+ | Day 1 |
| Concentration of anti-BP180 NC16A IgG autoantibodies by ELISA | Anti-BP180 NC16A IgG index; U/mL, cut-off value 9 U/mL | Day 1 |
| Concentration of anti-BP230 IgG autoantibodies by ELISA | Anti-BP230 IgG index; U/mL, cut-off value 9 U/mL | Day 1 |
| Detection of circulating pemphigoid specific IgG autoantibodies by immunoblot of keratinocyte extract | Presence/absence of circulating IgG autoantibodies against BP180 (180kDa) or BP230 (230kDa) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Age | For all subjects | Day 1 |
| Sex | For all subjects | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of 126 nursing home patients aged 65 years or above, living in a nursing home of the University Network Care of the Elderly - UMCG.
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| Name | Affiliation | Role |
|---|---|---|
| Marcel Jonkman, MD PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9700RB | Netherlands |
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| ID | Term |
|---|---|
| D010391 | Pemphigoid, Bullous |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Serum
| Comorbidities |
Presence/absence of comorbidities dementia, cerebrovascular accident, Parkinson's disease, other neurological disease or other diseases |
| Day 1 |
| Karnofsky Performance Scale | 0% - 100% | Day 1 |
| Medication | Registration of medication use for all subjects | Day 1 |
| Neuropsychiatric symptoms | Neuropsychiatric Inventory - Nursing Home version in Dutch | Day 1 |
| D007154 | Immune System Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |