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

NCT02521740 | Unknown

• 1 other identifier: 1318184
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregivers

Keywords

biological marker; frailty; burden; nutrition; elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Relation between biomarkers, subjective burden and the care receiver situation

  at baseline

Other Outcomes (5)

• Relation between biomarkers, subjective burden and the care receiver situation

  at baseline

• comparison of health events

  after 12 month

• relation between biomarkers at baseline and functional decline

  after 12 month

Study Arms (2)

caregivers

someone who takes care and lives with a disabled elderly

Other: Research questionnaires, blood sample

controls

someone who lives with an healthy elderly

Other: Research questionnaires, blood sample

Interventions

Research questionnaires, blood sample OTHER

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

caregivers; controls

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire UCLouvain Namur: lead
• University of Liege: collaborator
• University of Namur: collaborator

Study Sites (1)

CHU Dinant-Godinne

Mont-Godinne, Yvoir, 5530, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples taken between 8 and 11 am. Blood parameters including cell counts and assays of acute phase proteins (C-reactive protein (CRP), albumin, pre-albumin) are determined according to the routine of the hospital. PBMC are isolated by centrifugation in a Lympho-Ficoll gradient by the biobank of CHU Dinant Godinne. Collected plasma is stored at -80 °C until analysis. The amounts of insulin-like growth factor-1 (IGF-1), interleukin-6 (IL-6) are essayed by enzyme-linked immunosorbent assay (ELISA). PBMC are sent to Liege (GIGAI3) and Namur (URBC) for respectively ADN and ARN analyses. ADN analyses concerned the immunity markers and ARN analyses concerned the transcriptomics and epigenetic markers. The biobank of the CHU Dinant-Godinne meets the requirements of the quality book developed by the biobanks of Walonnie-Bruxelles (BWB).

MeSH Terms

Conditions

Frailty

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Marie de Saint-Hubert, MD, PhD

  CHUDinant-Godinne

  STUDY CHAIR

Central Study Contacts

florence potier, MD

CONTACT

0032/81 42 21 75; florence.potier@uclouvain.be

Marie de Saint-Hubert, MD, PhD

CONTACT

marie.desainthubert@uclouvain.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Directeur Médical adjoint aux missions universitaires

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: August 13, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

BE (1)