Pruritus and pemphigoid in nursing home patients

Pruritus and pemphigoid in nursing home patients - SSENIOR-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43546

Enrollment

126

Registered

2016-05-13

Start date

2016-07-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pruritus

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inpatient of a nursing home Age >= 65 years Subjects or their official representatives have signed informed consent

Exclusion criteria

Exclusion criteria: Age

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Netherlands

Outcome results