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.

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.

Study Overview

• Status: Unknown
• Conditions: Caregivers
• Intervention / Treatment: Other: Research questionnaires, blood sample

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Belgium
  • Yvoir
    • Mont-Godinne, Yvoir, Belgium, 5530
      • Recruiting
      • CHU Dinant-Godinne
      • Contact: florence potier, MD; Email: florence.potier@uclouvain.be
      • Principal Investigator: Florence Potier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• caregivers of a community dwelling dependent elderly (≥70years)
• controls : poeple who lives with a healthy elderly (≥70years)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
caregivers; someone who takes care and lives with a disabled elderly	Other: Research questionnaires, blood sample; assessment of health (frailty, nutrition, physical performance, depression, burden, sense of coherence, caregiver reaction)
controls; someone who lives with an healthy elderly	Other: Research questionnaires, blood sample; assessment of health (frailty, nutrition, physical performance, depression, burden, sense of coherence, caregiver reaction)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relation between biomarkers, subjective burden and the care receiver situation	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)	at baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relation between biomarkers, subjective burden and the care receiver situation	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)	at baseline
comparison of health events	Institutionalization, increase of formal home help services, hospitalisations	after 12 month
relation between biomarkers at baseline and functional decline		after 12 month
Levels of clinical markers across groups	frailty, physical performance, nutrition, depression	at baseline and after 12 month
relation between biomarkers at baseline and burden		after 12 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dinant Godinne - UCL Namur
• Collaborators: University of Liege; University of Namur
• Investigators: Study Chair: Marie de Saint-Hubert, MD, PhD, CHUDinant-Godinne

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: August 10, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 10, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: frailty; nutrition; elderly; burden; biological marker
• Other Study ID Numbers: 1318184