Pruritus and Pemphigoid in Nursing Home Patients (SSENIOR)

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.

Study Overview

• Status: Completed
• Conditions: Pruritus; Pemphigoid
• Intervention / Treatment: Other: Blood sample

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700RB
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Inpatient of a nursing home
• Age 65 years or above
• Subject or their official representatives have signed informed consent

Exclusion Criteria:

• Age below 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Blood sample; One extra blood sample of 10 ml will be taken during a routine venapunction for immunoserology testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	For all subjects	Day 1
Sex	For all subjects	Day 1
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

Collaborators and Investigators

• Sponsor: M.F. Jonkman
• Investigators: Principal Investigator: Marcel Jonkman, MD PhD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Pruritus; Bullous pemphigoid; Neuropsychiatric symptoms; Pemphigoid; Senile pruritus
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Skin Diseases, Vesiculobullous; Skin Manifestations; Pemphigoid, Bullous; Pruritus
• Other Study ID Numbers: NL56232.042.15; METc 2015/605 (Other Identifier: Medical Ethical Committee UMCG); NTR5843 (Registry Identifier: Nederlands Trial Register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED