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

Caregivers Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02521740
• Other study ID #: 1318184
• Status: Recruiting
• Phase: N/A
• First received: June 29, 2015
• Last updated: August 10, 2015
• Start date: March 2015
• Est. completion date: October 2017

Study information

• Verified date: August 2015
• Source: Centre Hospitalier Universitaire Dinant Godinne - UCL Namur
• Contact: florence potier, MD
• Phone: 0032/81 42 21 75
• Email: florence.potier[@]uclouvain.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Caregivers

Intervention

Other:
• Research questionnaires, blood sample
assessment of health (frailty, nutrition, physical performance, depression, burden, sense of coherence, caregiver reaction)

Locations

Country	Name	City	State
Belgium	CHU Dinant-Godinne	Mont-Godinne	Yvoir

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dinant Godinne - UCL Namur	University of Liege GIGA-I3, University of Namur RUCB

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	comparison of health events	Institutionalization, increase of formal home help services, hospitalisations	after 12 month	No
Other	relation between biomarkers at baseline and functional decline		after 12 month	No
Other	Levels of clinical markers across groups	frailty, physical performance, nutrition, depression	at baseline and after 12 month	No
Other	relation between biomarkers at baseline and burden		after 12 month	No
Primary	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	No
Secondary	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	No