CAREGIVER2, Caregiver's Health Assessment : Clinical and Biological Markers

• Conditions: Caregivers

• Registration Number: NCT02521740
• Lead Sponsor: Centre Hospitalier Universitaire UCLouvain Namur

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).

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-06-29
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-10
• Last Update Submitted: 2015-08-10
• Study First Posted: 2015-08-13
• Last Update Posted: 2015-08-13
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Levels of biomarkers across groups	at baseline	biomarkers of inflammation (cortisol, high sensitive C-Reactive Protein,Interleukin-6), immunity (TRECS, telomere length) and transcriptomics/epigenetics

Secondary Outcome Measures

Name	Time	Method
Relation between biomarkers, subjective burden and the care receiver situation	at baseline	biomarkers of inflammation (cortisol, high sensitive C-Reactive Protein,Interleukin-6), immunity (TRECS, telomere length) and transcriptomics/epigenetics and their relations with the Zarit burden, the caregiver reaction assessment, the depression scale and the sense of coherence scale and with the situation of the care receiver ( Katz index, cognitive impairment, behavioral disturbance)

Trial Locations

Locations (1)

CHU Dinant-Godinne; 🇧🇪 Mont-Godinne, Yvoir, Belgium

CHU Dinant-Godinne

🇧🇪Mont-Godinne, Yvoir, Belgium

florence potier, MD

Contact

florence.potier@uclouvain.be

Florence Potier, MD

Principal Investigator