CAREGIVER2, Caregiver's Health Assessment : Clinical and Biological Markers
10. august 2015 opdateret af: Professor Maximilien Gourdin, Centre Hospitalier Universitaire Dinant Godinne - UCL Namur
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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Observationel
Tilmelding (Forventet)
150
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Yvoir
-
Mont-Godinne, Yvoir, Belgien, 5530
- Rekruttering
- CHU Dinant-Godinne
-
Kontakt:
- florence potier, MD
- E-mail: florence.potier@uclouvain.be
-
Ledende efterforsker:
- Florence Potier, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
70 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
- caregivers of a community dwelling dependent elderly (≥70years)
- controls : poeple who lives with a healthy elderly (≥70years)
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
caregivers
someone who takes care and lives with a disabled elderly
|
assessment of health (frailty, nutrition, physical performance, depression, burden, sense of coherence, caregiver reaction)
|
|
controls
someone who lives with an healthy elderly
|
assessment of health (frailty, nutrition, physical performance, depression, burden, sense of coherence, caregiver reaction)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Levels of biomarkers across groups
Tidsramme: at baseline
|
biomarkers of inflammation (cortisol, high sensitive C-Reactive Protein,Interleukin-6), immunity (TRECS, telomere length) and transcriptomics/epigenetics
|
at baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Relation between biomarkers, subjective burden and the care receiver situation
Tidsramme: 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)
|
at baseline
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Relation between biomarkers, subjective burden and the care receiver situation
Tidsramme: 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)
|
at baseline
|
|
comparison of health events
Tidsramme: after 12 month
|
Institutionalization, increase of formal home help services, hospitalisations
|
after 12 month
|
|
relation between biomarkers at baseline and functional decline
Tidsramme: after 12 month
|
after 12 month
|
|
|
Levels of clinical markers across groups
Tidsramme: at baseline and after 12 month
|
frailty, physical performance, nutrition, depression
|
at baseline and after 12 month
|
|
relation between biomarkers at baseline and burden
Tidsramme: after 12 month
|
after 12 month
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Marie de Saint-Hubert, MD, PhD, CHUDinant-Godinne
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2015
Primær færdiggørelse (Forventet)
1. oktober 2017
Studieafslutning (Forventet)
1. oktober 2017
Datoer for studieregistrering
Først indsendt
29. juni 2015
Først indsendt, der opfyldte QC-kriterier
10. august 2015
Først opslået (Skøn)
13. august 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. august 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2015
Sidst verificeret
1. august 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 1318184
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .