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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02521740
Enrollment
150
Registered
2015-08-13
Start date
2015-03-31
Completion date
2017-10-31
Last updated
2015-08-13

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

Conditions

Caregivers

Keywords

biological marker, frailty, burden, nutrition, elderly

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).

Interventions

OTHERResearch questionnaires, blood sample

assessment of health (frailty, nutrition, physical performance, depression, burden, sense of coherence, caregiver reaction)

Sponsors

University of Liege
CollaboratorOTHER
University of Namur
CollaboratorOTHER
Centre Hospitalier Universitaire UCLouvain Namur
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Levels of biomarkers across groupsat baselinebiomarkers of inflammation (cortisol, high sensitive C-Reactive Protein,Interleukin-6), immunity (TRECS, telomere length) and transcriptomics/epigenetics

Secondary

MeasureTime frameDescription
Relation between biomarkers, subjective burden and the care receiver situationat baselinebiomarkers 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)

Other

MeasureTime frameDescription
relation between biomarkers at baseline and functional declineafter 12 month
Relation between biomarkers, subjective burden and the care receiver situationat baselinebiomarkers 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)
relation between biomarkers at baseline and burdenafter 12 month
Levels of clinical markers across groupsat baseline and after 12 monthfrailty, physical performance, nutrition, depression
comparison of health eventsafter 12 monthInstitutionalization, increase of formal home help services, hospitalisations

Countries

Belgium

Contacts

Primary Contactflorence potier, MD
florence.potier@uclouvain.be0032/81 42 21 75
Backup ContactMarie de Saint-Hubert, MD, PhD
marie.desainthubert@uclouvain.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026