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Pruritus and Pemphigoid in Nursing Home Patients (SSENIOR)

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ClinicalTrials.gov Identifier: NCT02823067
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
M.F. Jonkman, University Medical Center Groningen

Brief Summary:
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.

Condition or disease Intervention/treatment
Pemphigoid Pruritus 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.

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Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Pruritus and Pemphigoid in Nursing Home Patients
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Presence of pruritus [ Time Frame: Day 1 ]
    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.

  2. Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence on 1M salt-split human skin substrate [ Time Frame: Day 1 ]
    IgG autoantibodies with epidermal side staining of artificial split; positive/negative, staining intensity IgG 1+,2+,3+

  3. Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence microscopy on monkey esophagus substrate [ Time Frame: Day 1 ]
    Anti-basement membrane zone IgG autoantibodies; positive/negative, staining intensity IgG 1+,2+,3+

  4. Concentration of anti-BP180 NC16A IgG autoantibodies by ELISA [ Time Frame: Day 1 ]
    Anti-BP180 NC16A IgG index; U/mL, cut-off value 9 U/mL

  5. Concentration of anti-BP230 IgG autoantibodies by ELISA [ Time Frame: Day 1 ]
    Anti-BP230 IgG index; U/mL, cut-off value 9 U/mL

  6. Detection of circulating pemphigoid specific IgG autoantibodies by immunoblot of keratinocyte extract [ Time Frame: Day 1 ]
    Presence/absence of circulating IgG autoantibodies against BP180 (180kDa) or BP230 (230kDa)


Secondary Outcome Measures :
  1. Age [ Time Frame: Day 1 ]
    For all subjects

  2. Sex [ Time Frame: Day 1 ]
    For all subjects

  3. Comorbidities [ Time Frame: Day 1 ]
    Presence/absence of comorbidities dementia, cerebrovascular accident, Parkinson's disease, other neurological disease or other diseases

  4. Karnofsky Performance Scale [ Time Frame: Day 1 ]
    0% - 100%

  5. Medication [ Time Frame: Day 1 ]
    Registration of medication use for all subjects

  6. Neuropsychiatric symptoms [ Time Frame: Day 1 ]
    Neuropsychiatric Inventory - Nursing Home version in Dutch


Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823067


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
M.F. Jonkman
Investigators
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Principal Investigator: Marcel Jonkman, MD PhD University Medical Center Groningen

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Responsible Party: M.F. Jonkman, MD PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02823067     History of Changes
Other Study ID Numbers: NL56232.042.15
METc 2015/605 ( Other Identifier: Medical Ethical Committee UMCG )
NTR5843 ( Registry Identifier: Nederlands Trial Register )
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by M.F. Jonkman, University Medical Center Groningen:
Pemphigoid
Bullous pemphigoid
Pruritus
Senile pruritus
Neuropsychiatric symptoms
Additional relevant MeSH terms:
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Pruritus
Pemphigoid, Bullous
Skin Diseases
Skin Manifestations
Signs and Symptoms
Skin Diseases, Vesiculobullous
Autoimmune Diseases
Immune System Diseases