Social IsolationNCT05099042
Evaluating Quebec's Red-Cross Intervention
A study testing Recommendations and re-orientation towards appropriate physical, mental, and social health ressources in people with Social Isolation and Aging, run by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal at 1 site in Canada.
Trial summary
With the COVID-19 pandemic, elderly people (EP) living at home have seen their health deteriorated, thus increasing their needs in support and care. Indeed, while it was estimated that before the pandemic120 000 unattended living at home EP required care and services (taking bath, access to medication and food, etc.)… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Social Isolation, Aging
- What is being tested?
- Recommendations and re-orientation towards appropriate physical, mental, and social health ressources
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jun 2021to 27 Jul 2022
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 and more
- Living at home
- Be registered at the waiting list of GACO at the CIUSSS-Centre-Sud de l'île-de-Montréal (CCSMTL)
Who cannot join
- Principal address outside of the CCSMTL territory
- Participate at another clinical trial, to avoid interferences
- Not understand written or spoken French or English, questionnaires are only available in French and English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seniors Waiting for Medico-social Care at the CIUSSS-Centre-Sud de l'île de Montréal's Territory Waiting List (GACO) : Evaluation of the Intervention of a New Partner - Quebec's Red-Cross
With the COVID-19 pandemic, elderly people (EP) living at home have seen their health deteriorated, thus increasing their needs in support and care. Indeed, while it was estimated that before the pandemic120 000 unattended living at home EP required care and services (taking bath, access to medication and food, etc.), the number doubled after COVID-19. Therefore, the waiting list for socio-medical services for unattended vulnerable clientele without a family doctor grew from 1300 to 1715 EP in a couple of months during the pandemic. With these numbers, it becomes clear that an intervention is needed. Truly, the Institut National d'Excellence en Santé et Services Sociaux (INESSS) concludes that it was pivotal to first identify the most vulnerable EP and second re-orient them according to their needs.
Thus the principal investigator developed the Évaluation et orientation SOcio-GÉRiatrique (ESOGER) questionnaire available on a secure digital platform enabling both a rapid evaluation and intervention to asses EP needs and provide the adequate ressources. The principal investigator's previous research has demonstrated that ESOGER is one of the rare clinical tools of first contact in telehealth while being global, multidimensional, and equitable.
Hence, the principal investigator hypothesizes that ESOGER is a clinical tool enabling first line care by the Red-Cross to vulnerable EP without a family doctor, which will lead to an improvement in their health, autonomy and quality of life. Moreover, the principal investigator also hypothesizes that for a better deployment, the tool needs to be adapted to Red-Cross' need and EP service providers.
- Conditions
- Social Isolation, Aging
- Being tested
- Recommendations and re-orientation towards appropriate physical, mental, and social health ressources
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommendations and re-orientation towards appropriate physical, mental, and social health ressourcesOther
Resources recommendations and interventions curated to the needs of the EP such as refering them to a social activity for socially isolated EP.
| Study group | Role | What they receive |
|---|---|---|
| Group intervention - questionnaire and recommendations | Experimental | The intervention group will take the ESOGER questionnaire at month 0 and month 3 ( beginning and end) and receive recommendations following their needs. Receives: Other: Recommendations and re-orientation towards appropriate physical, mental, and social health ressources |
| Group control - questionnaire without recommendations | No intervention | The participants will only take the ESOGER questionnaire at month 0 and month 3 without recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 symptoms assessed through a questionnaire
presence or not of fever, cough, and shortness of breath (binary question)
Measured: 3 months
psychological fraility
Anxiety verbal analogic scale, score from 0= no anxiety to 10= extremly anxious
Measured: 3 months
Social health measured through a questionnaire
Issues related to medication and food delivery and access to home care. Presence or not of a shortage in food, medication and home care ( binary question)
Measured: 3 months
Socio-economic characteristics
Presence or not of socio-economic problems (binary questions)
Measured: 3 months
Participant's Quality of life
Measured by the EQ-5D scale with two parts, scale 1 score from 1= no problem to 5 ( sever health problems) and scale 2 visual analogic scale score from 0= worst possible health to 100= best possible health.
Measured: 3 months
Autonomy
ADL scale score from 0= very dependent to 6= very independent and IADL scale score 0= not autonomous 4= autonomous.
Measured: 3 months
Secondary outcomes (1)
Caregiver burden
Based on Zarit scale, score from 0= no burden to 16= high caregiver burden
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start28 Jun 2021
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social IsolationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Olivier Beauchet, Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099042
- Sponsor's protocol ID
- 2022-1418
- Status last verified
- Apr 2024
- First submitted
- 20 Sep 2021
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seniors Waiting for Medico-social Care at the CIUSSS-Centre-Sud de l'île de Montréal's Territory Waiting List (GACO) : Evaluation of the Intervention of a New Partner - Quebec's Red-Cross
- ClinicalTrials.gov ID
- NCT05099042
- Acronym / sponsor ID
- 2022-1418
- Conditions
- Social Isolation, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-MontréalOther government
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 29 Oct 2021 (actual)
- 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.
With the COVID-19 pandemic, elderly people (EP) living at home have seen their health deteriorated, thus increasing their needs in support and care. Indeed, while it was estimated that before the pandemic120 000 unattended living at home EP required care and services (taking bath, access to medication and food, etc.), the number doubled after COVID-19. Therefore, the waiting list for socio-medical services for unattended vulnerable clientele without a family doctor grew from 1300 to 1715 EP in a couple of months during the pandemic. With these numbers, it becomes clear that an intervention is needed. Truly, the Institut National d'Excellence en Santé et Services Sociaux (INESSS) concludes that it was pivotal to first identify the most vulnerable EP and second re-orient them according to their needs.
Thus the principal investigator developed the Évaluation et orientation SOcio-GÉRiatrique (ESOGER) questionnaire available on a secure digital platform enabling both a rapid evaluation and intervention to asses EP needs and provide the adequate ressources. The principal investigator's previous research has demonstrated that ESOGER is one of the rare clinical tools of first contact in telehealth while being global, multidimensional, and equitable.
Hence, the principal investigator hypothesizes that ESOGER is a clinical tool enabling first line care by the Red-Cross to vulnerable EP without a family doctor, which will lead to an improvement in their health, autonomy and quality of life. Moreover, the principal investigator also hypothesizes that for a better deployment, the tool needs to be adapted to Red-Cross' need and EP service providers.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group intervention - questionnaire and recommendations | Experimental | Other: Recommendations and re-orientation towards appropriate physical, mental, and social health ressourcesThe intervention group will take the ESOGER questionnaire at month 0 and month 3 ( beginning and end) and receive recommendations following their needs. |
| Group control - questionnaire without recommendations | No intervention | –The participants will only take the ESOGER questionnaire at month 0 and month 3 without recommendations. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 65 and more
- Living at home
- Be registered at the waiting list of GACO at the CIUSSS-Centre-Sud de l'île-de-Montréal (CCSMTL)
Key exclusion criteria (3 listed)
- Principal address outside of the CCSMTL territory
- Participate at another clinical trial, to avoid interferences
- Not understand written or spoken French or English, questionnaires are only available in French and English.
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 |
|---|---|---|
| Recommendations and re-orientation towards appropriate physical, mental, and social health ressourcesResources recommendations and interventions curated to the needs of the EP such as refering them to a social activity for socially isolated EP. | Other | Group intervention - questionnaire and recommendations |
Primary outcome
COVID-19 symptoms assessed through a questionnaire
Time frame: 3 months
presence or not of fever, cough, and shortness of breath (binary question)
psychological fraility
Time frame: 3 months
Anxiety verbal analogic scale, score from 0= no anxiety to 10= extremly anxious
Social health measured through a questionnaire
Time frame: 3 months
Issues related to medication and food delivery and access to home care. Presence or not of a shortage in food, medication and home care ( binary question)
Socio-economic characteristics
Time frame: 3 months
Presence or not of socio-economic problems (binary questions)
Participant's Quality of life
Time frame: 3 months
Measured by the EQ-5D scale with two parts, scale 1 score from 1= no problem to 5 ( sever health problems) and scale 2 visual analogic scale score from 0= worst possible health to 100= best possible health.
Autonomy
Time frame: 3 months
ADL scale score from 0= very dependent to 6= very independent and IADL scale score 0= not autonomous 4= autonomous.
1 secondary outcome
Caregiver burden
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recommendations and re-orientation towards appropriate physical, mental, and social health ressources in people with Social Isolation and Aging, 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 10 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
COVID-19 symptoms assessed through a questionnaire (time frame: 3 months). The study lists 6 primary outcomes in all. 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 10 Apr 2024.