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Caregiver WellbeingPPANCT06724757

Survey for Caregivers Aged 50 and Over

An observational study of Caregiver Wellbeing and Caregiver Mental Health, run by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal at 1 site in Canada.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

There are more and more informal caregivers (PPA) in Quebec. Their increase between 2012 and 2018, according to data from the "General Social Survey - Care Given and Received," was significant, around 32%. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
What is being tested?
Health questionnaire
How many people
10,000 participants
Where
1 siteCanada
Study dates
25 Sep 2024to 25 Jun 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Caregivers aged 50 years old and older living in Quebec

Who may be able to join

  • Be a caregiver
  • Be 50 years old or older
  • Reside in Quebec for at least 6 months and 1 day of the year
  • Have an internet connection with an electronic device (computer, touch tablet or smartphone)
  • Read and understand written French or English. The questionnaire is only available in these 2 languages.

Who cannot join

  • Living in a Centre d'Hébergement et de Soins de Longue Durée (CHSLD) (long-term care centre) or in the medicalized sector of a seniors' residence.
  • Participate in a concurrent interventional study (study involving medication or therapeutic intervention, etc.).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site

  • CRIUGM

    Montreal, Quebec, H3W 1W5

Other trials in Canada

About this study

There are more and more informal caregivers (PPA) in Quebec. Their increase between 2012 and 2018, according to data from the "General Social Survey - Care Given and Received," was significant, around 32%. The available data paint a typical portrait of a Quebec caregiver: (a) she is a woman, (b) aged between 50-55 years, (c) who devotes at least 3 hours of her time per week, on a regular basis, (d) to caring for an elderly parent. To this date, there is no reliable data on the health status-whether mental, physical, or social-of caregivers in Quebec. Yet this information is crucial because it affects the ability of caregivers to fulfill their role and, consequently, the stable health of the individuals they care for, allowing them to continue living at home. This situation exposes caregivers to a decline in their own health, and by extension, the health of those they care for. The fact that the typical Quebec caregiver is 50 years old or older increases the risk of health deterioration within the caregiver-care receiver pair. Indeed, age 50 is when the effects of physiological and pathological aging begin to impact the physical capacities of the elderly. Developing new practices that focus on the health characteristics of both caregivers and care receivers, in order to prevent health deterioration, is therefore a crucial step in supporting caregivers in their role and ensuring that care receivers can stay at home in good conditions for as long as possible.

The issue of caregivers' health is still under-addressed in Quebec, both in the scientific literature and in population surveys. It seems that caregivers need a comprehensive evaluation of their health status (physical, mental, and social), given the significant impact caregiving has on their health. Research conducted within the Living Lab, led by Dr. Beauchet's team, has helped develop tools and questionnaires that effectively assess the frailty of individuals aged 50 and over and produce reports that raise awareness about their health status, enabling them to implement future care solutions that meet their needs.

The overall objective is to assess the health status (mental, physical, social) of caregivers aged 50 and over, living in Quebec-through self-assessment to make them aware of their actual health condition and engage them in a process of self-care.

Being tested
Health questionnaire

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health questionnaireOther

    The intervention involves the completion and analysis of an online questionnaire designed to assess the health (mental, physical, social) of caregivers aged 50 and over in Quebec. This assessment is based on a combination of questionnaires (CARE, 4-item Zarit scale, 4-item GDS, 3-item UCLA loneliness scale, etc.).

Study groups in NCT06724757
Study groupRoleWhat they receive
CaregiverCaregivers aged 50 years old and older living in Quebec
Receives: Other: Health questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical health using the CARE frailty scale

    CARE is a frailty scale. The AgeTeQ team has developed this scale, which enables frailty to be assessed via a standardized self-questionnaire comprising 22 simple questions, 20 of which are based on a binary response (yes versus no) and two on numerical. CARE is based on a cumulative deficit approach to measuring frailty. Each response is assigned a point 1 if there is a deficit, and 0 if there is no deficit.

    The CARE score ranges from 0 (no deficits) to 21 (maximum cumulative deficits). This score has been segmented into 3 levels using a validated approach to determine 3 levels of frailty:

    • The robust level: score between 0 and 1.
    • Pre-fragile level: score between 2 and 4.
    • Fragile level: score > 5.

    Measured: Questionnaire completed once (15 minutes) between October 2024 and February 2025

Secondary outcomes (5)

  1. Caregiver burden with the 4-item Zarit score (/20)

    The caregiver burden is assessed using the 4-item Zarit scale. This scale asks four questions that reflect how caregivers feel when caring for their loved ones. For each statement, the respondent is asked to indicate a frequency: never, rarely, sometimes, quite often and almost always.

    Measured: Questionnaire completed once (15 minutes) between October 2024 and February 2025

  2. Depression with the 4-item GDS score (/4)

    The Geriatric Depression Scale or GDS was designed to assess the presence of depressive feelings and suicidal intentions in the elderly. It is essentially a screening test for depressive impairment or state. The GDS is initially composed of 30 questions with a binary response choice (yes or no). For reasons of questionnaire length, it was decided to use an abbreviated version of the GDS with 4 items. The GDS then gives a score between 0 and 4, with 0 corresponding to a very high probability of no depression, and 1 or more corresponding to a very high probability of depression.

    Measured: Questionnaire completed once (15 minutes) between October 2024 and February 2025

  3. Social isolation

    A question is asked to measure the social isolation of caregivers, taking into account the number of contacts (in person or by telephone) with people outside the household (friends, family, professionals).

    Measured: Questionnaire completed once (15 minutes) between October 2024 and February 2025

  4. Loneliness with the UCLA score (/9)

    The 3-item UCLA scale is a screening tool for loneliness in adults. The scale consists of three questions, with frequency options: never, sometimes and often. The score can vary between 3 and 9. A high score indicates a high degree of loneliness.

    Measured: Questionnaire completed once (15 minutes) between October 2024 and February 2025

  5. Perceived health scores

    Three additional questions are asked in the form of a scale (ranging from 0 to 10) to assess the perceived health of caregivers. For each domain, the respondent is asked to indicate his or her state of perceived health, ranging from 0 (the worst state of health the respondent can imagine) to 10 (the best state of health the respondent can imagine). Three health domains are investigated: psychological health, physical health and social isolation.

    Measured: Questionnaire completed once (15 minutes) between October 2024 and February 2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2024
  2. Study start25 Sep 2024
  3. Primary completion25 Feb 2025 (estimated)
  4. Study completion25 Jun 2025 (estimated)

Resources

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 only
Time perspective
Cross-sectional
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06724757
Sponsor's protocol ID
2025-2165
Acronym
PPA
Status last verified
Dec 2024
First submitted
5 Dec 2024
Last updated
12 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Caregiver Wellbeing and Caregiver Mental Health, run by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal at 1 site in Canada.

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 5 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 12 Dec 2024. 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 Canada. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical health using the CARE frailty scale (time frame: Questionnaire completed once (15 minutes) between October 2024 and February 2025). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06724757.

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 12 Dec 2024; AzTrials last refreshed its copy on 3 Nov 2026.

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