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

Sponsor

Centre Hospitalier Universitaire Dinant Godinne - UCL Namur (Other)

Overall Status

Unknown status

CT.gov ID

NCT02521740

Collaborator

University of Liege (Other), University of Namur (Other)

150

Enrollment

Location

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caregivers	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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2017

Anticipated Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

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

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)

Other Outcome Measures

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)
comparison of health events [after 12 month]
Institutionalization, increase of formal home help services, hospitalisations
relation between biomarkers at baseline and functional decline [after 12 month]
Levels of clinical markers across groups [at baseline and after 12 month]
frailty, physical performance, nutrition, depression
relation between biomarkers at baseline and burden [after 12 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Dinant-Godinne	Mont-Godinne	Yvoir	Belgium	5530

Sponsors and Collaborators

Centre Hospitalier Universitaire Dinant Godinne - UCL Namur
University of Liege
University of Namur

Investigators

Study Chair: Marie de Saint-Hubert, MD, PhD, CHUDinant-Godinne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Professor Maximilien Gourdin, Directeur Médical adjoint aux missions universitaires, Centre Hospitalier Universitaire Dinant Godinne - UCL Namur

ClinicalTrials.gov Identifier:

NCT02521740

Other Study ID Numbers:

1318184

First Posted:

Aug 13, 2015

Last Update Posted:

Aug 13, 2015

Last Verified:

Aug 1, 2015

Keywords provided by Professor Maximilien Gourdin, Directeur Médical adjoint aux missions universitaires, Centre Hospitalier Universitaire Dinant Godinne - UCL Namur

Study Results

No Results Posted as of Aug 13, 2015