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Clinical Trials/NCT02521740
NCT02521740
Unknown
Not Applicable

Soutien Des Soins Informels Aux Personnes âgées Fragiles : Accompagnement Des Aidants Sur Base d'Une évaluation Clinique et Biologique de la Charge de Soins.

Centre Hospitalier Universitaire UCLouvain Namur1 site in 1 country150 target enrollmentMarch 2015
ConditionsCaregivers

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Caregivers
Sponsor
Centre Hospitalier Universitaire UCLouvain Namur
Enrollment
150
Locations
1
Primary Endpoint
Levels of biomarkers across groups
Last Updated
10 years ago

Overview

Brief Summary

Providing care for a disabled elderly may represent a risk for the health of the caregiver. The objective of the study is to assess the impact of caregiving in terms of clinical and biological markers in relation to disability and cognitive impairment.

Detailed Description

The investigators hypothesize that an accumulation of stressful events related to care giving may induce a stress response to the caregiver. This stress response can be measured by biological markers (inflammation, transcription and immunity) and also by clinical markers (frailty, physical performance, nutrition). This stress response can be influenced by the subjective burden of the caregiver and by the severity of the disease of the care receiver (Activity of daily life capabilities, cognitive function, behavioral disturbance).

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
October 2017
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire UCLouvain Namur
Responsible Party
Principal Investigator
Principal Investigator

Professor Maximilien Gourdin

Directeur Médical adjoint aux missions universitaires

Centre Hospitalier Universitaire UCLouvain Namur

Eligibility Criteria

Inclusion Criteria

  • living with the care-receiver ( or with a healthy elderly for the controls)
  • care-receiver dependent for at least one Activity of the daily living ( Katz index) or having cognitive disorder ( \>2 Global Deterioration Scale)

Exclusion Criteria

  • institutionalised elderly
  • inability to understand and speak french
  • Acute disease within the past month
  • Anti-inflammatory or immuno-suppressive treatment
  • End-of-life care

Outcomes

Primary Outcomes

Levels of biomarkers across groups

Time Frame: at baseline

biomarkers of inflammation (cortisol, high sensitive C-Reactive Protein,Interleukin-6), immunity (TRECS, telomere length) and transcriptomics/epigenetics

Secondary Outcomes

  • Relation between biomarkers, subjective burden and the care receiver situation(at baseline)

Study Sites (1)

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