CaregiversNCT02521740
CAREGIVER2, Caregiver's Health Assessment : Clinical and Biological Markers
An observational study of Caregivers, run by Centre Hospitalier Universitaire UCLouvain Namur at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers
- What is being tested?
- Research questionnaires, blood sample
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2015to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: * caregivers of a community dwelling dependent elderly (≥70years) * controls : poeple who lives with a healthy elderly (≥70years)
Who may be able to join
- 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)
Who cannot join
- institutionalised elderly
- inability to understand and speak french
- Acute disease within the past month
- Anti-inflammatory or immuno-suppressive treatment
- End-of-life care
Trial locations and contacts
1 site in 1 country.
Marie de Saint-Hubert, MD, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
CHU Dinant-Godinne
Mont-Godinne, Yvoir, 5530
florence potier, MD, florence.potier@uclouvain.be
Florence Potier, MD
About this study
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.
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.
Read the 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).
- Conditions
- Caregivers
- Being tested
- Research questionnaires, blood sample
- Keywords
- biological marker, frailty, burden, nutrition, elderly
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research questionnaires, blood sampleOther
assessment of health (frailty, nutrition, physical performance, depression, burden, sense of coherence, caregiver reaction)
| Study group | Role | What they receive |
|---|---|---|
| caregivers | someone who takes care and lives with a disabled elderly Receives: Other: Research questionnaires, blood sample | |
| controls | someone who lives with an healthy elderly Receives: Other: Research questionnaires, blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of biomarkers across groups
biomarkers of inflammation (cortisol, high sensitive C-Reactive Protein,Interleukin-6), immunity (TRECS, telomere length) and transcriptomics/epigenetics
Measured: at baseline
Secondary outcomes (1)
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)
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiversStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire UCLouvain Namur
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liege, University of Namur
- Responsible party
- Principal investigator, Professor Maximilien Gourdin, Centre Hospitalier Universitaire UCLouvain Namur
- Investigators
- Marie de Saint-Hubert, MD, PhD, Study chair, CHUDinant-Godinne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521740
- Sponsor's protocol ID
- 1318184
- Status last verified
- Aug 2015
- First submitted
- 29 Jun 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02521740
- Acronym / sponsor ID
- 1318184
- Conditions
- Caregivers
- Keywords
- biological marker, frailty, burden, nutrition, elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire UCLouvain NamurUniversity, hospital or other
- Collaborators
- University of Liege, University of Namur
- Study start
- Mar 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| caregivers | – | Other: Research questionnaires, blood samplesomeone who takes care and lives with a disabled elderly |
| controls | – | Other: Research questionnaires, blood samplesomeone who lives with an healthy elderly |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- * caregivers of a community dwelling dependent elderly (≥70years) * controls : poeple who lives with a healthy elderly (≥70years)
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- institutionalised elderly
- inability to understand and speak french
- Acute disease within the past month
- Anti-inflammatory or immuno-suppressive treatment
- End-of-life care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research questionnaires, blood sampleassessment of health (frailty, nutrition, physical performance, depression, burden, sense of coherence, caregiver reaction) | Other | caregivers, controls |
Primary outcome
Levels of biomarkers across groups
Time frame: at baseline
biomarkers of inflammation (cortisol, high sensitive C-Reactive Protein,Interleukin-6), immunity (TRECS, telomere length) and transcriptomics/epigenetics
1 secondary outcome
Relation between biomarkers, subjective burden and the care receiver situation
Time frame: at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie de Saint-Hubert, MD, PhD contact
Marie de Saint-Hubert, MD, PhD study chair
CHUDinant-Godinne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregivers, run by Centre Hospitalier Universitaire UCLouvain Namur at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact florence potier, MD (0032/81 42 21 75, florence.potier@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of biomarkers across groups (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.