CaregiversCaringForwrdNCT05302245
A Longitudinal Examination of Unpaid Caregivers of Acquired Brain Injury (ABI) Survivors in Nova Scotia
An observational study of Caregivers, run by IWK Health Centre at 1 site in Canada.
Trial summary
The purpose of the present study is to follow unpaid caregivers of ABI survivors in Nova Scotia over time to learn more about their experiences. The study is funded by the Government of Nova Scotia (i.e. Department of Health and Wellness). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregivers
- How many people
- 2,000 participants
- Where
- 1 siteCanada
- Study dates
- 30 Oct 2020to 30 Mar 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Caregivers of ABI survivors living in Nova Scotia.
Who may be able to join
- Participant is an unpaid, informal, caregiver of an ABI survivor
- Participant live in Nova Scotia
- Participant is able to read, write and understand English
- Participant has access to a tablet, smart phone, or computer with high speed internet
- Participant consents to complete online study questionnaires
Who cannot join
- Participant is a paid, professional caregiver of an ABI survivor
- Participant does not live in Nova Scotia
- Participant is not able to read, write and understand English
- Participant does not have access to a tablet, smart phone, or computer with high speed internet
- Participant does not consent to complete online study questionnaires
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
IWK Health Centre
Halifax, Nova Scotia
Andre Lauzon, (902) 470-8160, Andre.Lauzon@iwk.nshealth.ca
Patrick McGrath
About this study
Official title: Caring Forward: A Longitudinal Examination of Unpaid Caregivers of Acquired Brain Injury (ABI) Survivors in Nova Scotia
The purpose of the present study is to follow unpaid caregivers of ABI survivors in Nova Scotia over time to learn more about their experiences. The study is funded by the Government of Nova Scotia (i.e. Department of Health and Wellness). The present longitudinal cohort study will help increase knowledge about ABI caregivers at a provincial level. Findings will also be used in developing future interventions to help caregivers in this population.
The goals of the research study are:
- To understand the natural experiences of unpaid caregivers over time. More specifically, the investigators hope to learn about the experiences of unpaid caregivers of acquired brain injury survivors in Nova Scotia.
- To examine the connection between study demographic variables (e.g. the amount of time spent caregiving in hours per week), and psychological outcome variables (e.g. caregiver burden).
- To learn about the relationship between psychological outcome variables (e.g. psychological distress and savouring).
- To provide a platform for future studies using the Trials within Cohort (TwiC) study design.
Read the detailed description
The Investigators are employing a Trials within Cohorts research design. That is, they are conducting a prospective longitudinal cohort study, with the cohort serving as a platform in which future studies or interventions can be tested. In accordance with this approach, eligible participants who have given consent to be contacted in the future may be selected and approached for future participation in randomized controlled trials.
- Conditions
- Caregivers
- Keywords
- Caregivers, Acquired brain injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers of ABI survivors | Unpaid caregivers of acquired brain injury survivors living in Nova Scotia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological strain
The Depression, Anxiety, and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995), a 21-item self-report measure that will assess caregiver's levels of psychological strain over the last week in three distinct categories; depression (e.g. hopelessness, depressed mood), anxiety (e.g. fear, anticipation of negative events), and stress (e.g. prolonged state of arousal, difficulty relaxing).
Measured: At baseline.
Psychological strain
The Depression, Anxiety, and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995), a 21-item self-report measure that will assess caregiver's levels of psychological strain over the last week in three distinct categories; depression (e.g. hopelessness, depressed mood), anxiety (e.g. fear, anticipation of negative events), and stress (e.g. prolonged state of arousal, difficulty relaxing).
Measured: Six months following baseline.
Psychological strain
The Depression, Anxiety, and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995), a 21-item self-report measure that will assess caregiver's levels of psychological strain over the last week in three distinct categories; depression (e.g. hopelessness, depressed mood), anxiety (e.g. fear, anticipation of negative events), and stress (e.g. prolonged state of arousal, difficulty relaxing).
Measured: Twelve months following baseline.
Psychological strain
The Depression, Anxiety, and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995), a 21-item self-report measure that will assess caregiver's levels of psychological strain over the last week in three distinct categories; depression (e.g. hopelessness, depressed mood), anxiety (e.g. fear, anticipation of negative events), and stress (e.g. prolonged state of arousal, difficulty relaxing).
Measured: Eighteen months following baseline.
Psychological strain
The Depression, Anxiety, and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995), a 21-item self-report measure that will assess caregiver's levels of psychological strain over the last week in three distinct categories; depression (e.g. hopelessness, depressed mood), anxiety (e.g. fear, anticipation of negative events), and stress (e.g. prolonged state of arousal, difficulty relaxing).
Measured: Twenty four months following baseline.
Secondary outcomes (30)
Caregiver's perception of brain injury services in the community
Services Obstacles Scale (SOS; Kolakowsky-Hayner et al., 2000), a 6-item scale that will be used to assess caregivers' perceptions of brain injury services in the community. The scale has three main components upon which the questions are based: 1) satisfaction with treatment resources; 2) finances as an obstacle to receiving services; and 3) transportation as an obstacle to receiving services.
Measured: At baseline.
Caregiver's perception of brain injury services in the community
Services Obstacles Scale (SOS; Kolakowsky-Hayner et al., 2000), a 6-item scale that will be used to assess caregivers' perceptions of brain injury services in the community. The scale has three main components upon which the questions are based: 1) satisfaction with treatment resources; 2) finances as an obstacle to receiving services; and 3) transportation as an obstacle to receiving services.
Measured: Six months following baseline.
Caregiver's perception of brain injury services in the community
Services Obstacles Scale (SOS; Kolakowsky-Hayner et al., 2000), a 6-item scale that will be used to assess caregivers' perceptions of brain injury services in the community. The scale has three main components upon which the questions are based: 1) satisfaction with treatment resources; 2) finances as an obstacle to receiving services; and 3) transportation as an obstacle to receiving services.
Measured: Twelve months following baseline.
Caregiver's perception of brain injury services in the community
Services Obstacles Scale (SOS; Kolakowsky-Hayner et al., 2000), a 6-item scale that will be used to assess caregivers' perceptions of brain injury services in the community. The scale has three main components upon which the questions are based: 1) satisfaction with treatment resources; 2) finances as an obstacle to receiving services; and 3) transportation as an obstacle to receiving services.
Measured: Eighteen months following baseline.
Caregiver's perception of brain injury services in the community
Services Obstacles Scale (SOS; Kolakowsky-Hayner et al., 2000), a 6-item scale that will be used to assess caregivers' perceptions of brain injury services in the community. The scale has three main components upon which the questions are based: 1) satisfaction with treatment resources; 2) finances as an obstacle to receiving services; and 3) transportation as an obstacle to receiving services.
Measured: Twenty four months following baseline.
Social support
The Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al., 1988), a 12-item scale that will assess caregivers' perceived social support from three sources; family, friends, and a significant other.
Measured: At baseline.
Social support
The Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al., 1988), a 12-item scale that will assess caregivers' perceived social support from three sources; family, friends, and a significant other.
Measured: Six months following baseline.
Social support
The Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al., 1988), a 12-item scale that will assess caregivers' perceived social support from three sources; family, friends, and a significant other.
Measured: Twelve months following baseline.
Social support
The Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al., 1988), a 12-item scale that will assess caregivers' perceived social support from three sources; family, friends, and a significant other.
Measured: Eighteen months following baseline.
Social support
The Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al., 1988), a 12-item scale that will assess caregivers' perceived social support from three sources; family, friends, and a significant other.
Measured: Twenty four months following baseline.
Savouring
The Savouring Configuration Inventory (SCI; Lauzon \& Green-Demers, 2020), which measures hedonic savouring, and eudaimonic savouring of meaning of life, spirituality, self-reflection, inspiration, appreciation, and gratitude. It comprises 28 scenarios (4 subscales), paired with a single item.
Measured: At baseline.
Savouring
The Savouring Configuration Inventory (SCI; Lauzon \& Green-Demers, 2020), which measures hedonic savouring, and eudaimonic savouring of meaning of life, spirituality, self-reflection, inspiration, appreciation, and gratitude. It comprises 28 scenarios (4 subscales), paired with a single item.
Measured: Six months following baseline.
Savouring
The Savouring Configuration Inventory (SCI; Lauzon \& Green-Demers, 2020), which measures hedonic savouring, and eudaimonic savouring of meaning of life, spirituality, self-reflection, inspiration, appreciation, and gratitude. It comprises 28 scenarios (4 subscales), paired with a single item.
Measured: Twelve months following baseline.
Savouring
The Savouring Configuration Inventory (SCI; Lauzon \& Green-Demers, 2020), which measures hedonic savouring, and eudaimonic savouring of meaning of life, spirituality, self-reflection, inspiration, appreciation, and gratitude. It comprises 28 scenarios (4 subscales), paired with a single item.
Measured: Eighteen months following baseline.
Savouring
The Savouring Configuration Inventory (SCI; Lauzon \& Green-Demers, 2020), which measures hedonic savouring, and eudaimonic savouring of meaning of life, spirituality, self-reflection, inspiration, appreciation, and gratitude. It comprises 28 scenarios (4 subscales), paired with a single item.
Measured: Twenty four months following baseline.
Overall quality of life and general health
The World Health Organization Quality of Life Assessment -BREF (WHOQOL-BREF; Whoqol Group, 1998), a 26-item measure that assesses quality of life in four distinct domains: physical health, psychological health, social relationships and the environment. A weighted summary score from 0-100 is calculated for each domain, with higher scores indicating higher quality of life.
Measured: At baseline.
Overall quality of life and general health
The World Health Organization Quality of Life Assessment -BREF (WHOQOL-BREF; Whoqol Group, 1998), a 26-item measure that assesses quality of life in four distinct domains: physical health, psychological health, social relationships and the environment. A weighted summary score from 0-100 is calculated for each domain, with higher scores indicating higher quality of life.
Measured: Six months following baseline.
Overall quality of life and general health
The World Health Organization Quality of Life Assessment -BREF (WHOQOL-BREF; Whoqol Group, 1998), a 26-item measure that assesses quality of life in four distinct domains: physical health, psychological health, social relationships and the environment. A weighted summary score from 0-100 is calculated for each domain, with higher scores indicating higher quality of life.
Measured: Twelve months following baseline.
Overall quality of life and general health
The World Health Organization Quality of Life Assessment -BREF (WHOQOL-BREF; Whoqol Group, 1998), a 26-item measure that assesses quality of life in four distinct domains: physical health, psychological health, social relationships and the environment. A weighted summary score from 0-100 is calculated for each domain, with higher scores indicating higher quality of life.
Measured: Eighteen months following baseline.
Overall quality of life and general health
The World Health Organization Quality of Life Assessment -BREF (WHOQOL-BREF; Whoqol Group, 1998), a 26-item measure that assesses quality of life in four distinct domains: physical health, psychological health, social relationships and the environment. A weighted summary score from 0-100 is calculated for each domain, with higher scores indicating higher quality of life.
Measured: Twenty four months following baseline.
Caregiver burden
The Zarit Burden Interview-Short Form (ZBI-SF; Bedard et al., 2001), a 12-item measure that assesses individuals' perceived burden of providing care to their loved one.
Measured: At baseline.
Caregiver burden
The Zarit Burden Interview-Short Form (ZBI-SF; Bedard et al., 2001), a 12-item measure that assesses individuals' perceived burden of providing care to their loved one.
Measured: Six months following baseline.
Caregiver burden
The Zarit Burden Interview-Short Form (ZBI-SF; Bedard et al., 2001), a 12-item measure that assesses individuals' perceived burden of providing care to their loved one.
Measured: Twelve months following baseline.
Caregiver burden
The Zarit Burden Interview-Short Form (ZBI-SF; Bedard et al., 2001), a 12-item measure that assesses individuals' perceived burden of providing care to their loved one.
Measured: Eighteen months following baseline.
Caregiver burden
The Zarit Burden Interview-Short Form (ZBI-SF; Bedard et al., 2001), a 12-item measure that assesses individuals' perceived burden of providing care to their loved one.
Measured: Twenty four months following baseline.
Caregiving self-efficacy
The Controlling Upsetting Thoughts about Caregiving subscale from the 15-item Revised Scale for Caregiving Self-Efficacy (RSCSE; Steffen et al. 2002), that measure caregivers level of confidence with higher scores indicating higher levels of self-efficacy.
Measured: At baseline.
Caregiving self-efficacy
The Controlling Upsetting Thoughts about Caregiving subscale from the 15-item Revised Scale for Caregiving Self-Efficacy (RSCSE; Steffen et al. 2002), that measure caregivers level of confidence with higher scores indicating higher levels of self-efficacy.
Measured: Six months following baseline.
Caregiving self-efficacy
The Controlling Upsetting Thoughts about Caregiving subscale from the 15-item Revised Scale for Caregiving Self-Efficacy (RSCSE; Steffen et al. 2002), that measure caregivers level of confidence with higher scores indicating higher levels of self-efficacy.
Measured: Twelve months following baseline.
Caregiving self-efficacy
The Controlling Upsetting Thoughts about Caregiving subscale from the 15-item Revised Scale for Caregiving Self-Efficacy (RSCSE; Steffen et al. 2002), that measure caregivers level of confidence with higher scores indicating higher levels of self-efficacy.
Measured: Eighteen months following baseline.
Caregiving self-efficacy
The Controlling Upsetting Thoughts about Caregiving subscale from the 15-item Revised Scale for Caregiving Self-Efficacy (RSCSE; Steffen et al. 2002), that measure caregivers level of confidence with higher scores indicating higher levels of self-efficacy.
Measured: Twenty four months following baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start30 Oct 2020
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick J. McGrath, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302245
- Sponsor's protocol ID
- 1025568
- Other IDs
- 1025253
- Acronym
- CaringForwrd
- Status last verified
- May 2023
- First submitted
- 15 Mar 2021
- Last updated
- 30 May 2023
- Results posted
- No
- Individual data sharing
- Yes: Participants will be asked to indicate during Informed Consent whether their de-identified data may be shared with other researchers, provided the study is approved by an ethics board and researchers agree to use the data only for the purposes described in the approved research study. De-identified data from all outcome measures will be made available to approved researchers upon request, provided individual participants have provided consent.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring Forward: A Longitudinal Examination of Unpaid Caregivers of Acquired Brain Injury (ABI) Survivors in Nova Scotia
- ClinicalTrials.gov ID
- NCT05302245
- Acronym / sponsor ID
- CaringForwrd / 1025568
- Conditions
- Caregivers
- Keywords
- Caregivers, Acquired brain injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 31 Mar 2022 (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.
The purpose of the present study is to follow unpaid caregivers of ABI survivors in Nova Scotia over time to learn more about their experiences. The study is funded by the Government of Nova Scotia (i.e. Department of Health and Wellness). The present longitudinal cohort study will help increase knowledge about ABI caregivers at a provincial level. Findings will also be used in developing future interventions to help caregivers in this population.
The goals of the research study are:
- To understand the natural experiences of unpaid caregivers over time. More specifically, the investigators hope to learn about the experiences of unpaid caregivers of acquired brain injury survivors in Nova Scotia.
- To examine the connection between study demographic variables (e.g. the amount of time spent caregiving in hours per week), and psychological outcome variables (e.g. caregiver burden).
- To learn about the relationship between psychological outcome variables (e.g. psychological distress and savouring).
- To provide a platform for future studies using the Trials within Cohort (TwiC) study design.
Detailed description
The Investigators are employing a Trials within Cohorts research design. That is, they are conducting a prospective longitudinal cohort study, with the cohort serving as a platform in which future studies or interventions can be tested. In accordance with this approach, eligible participants who have given consent to be contacted in the future may be selected and approached for future participation in randomized controlled trials.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers of ABI survivors | – | –Unpaid caregivers of acquired brain injury survivors living in Nova Scotia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Caregivers of ABI survivors living in Nova Scotia.
Key inclusion criteria (5 listed)
- Participant is an unpaid, informal, caregiver of an ABI survivor
- Participant live in Nova Scotia
- Participant is able to read, write and understand English
- Participant has access to a tablet, smart phone, or computer with high speed internet
- Participant consents to complete online study questionnaires
Key exclusion criteria (5 listed)
- Participant is a paid, professional caregiver of an ABI survivor
- Participant does not live in Nova Scotia
- Participant is not able to read, write and understand English
- Participant does not have access to a tablet, smart phone, or computer with high speed internet
- Participant does not consent to complete online study questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychological strain
Time frame: At baseline.
The Depression, Anxiety, and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995), a 21-item self-report measure that will assess caregiver's levels of psychological strain over the last week in three distinct categories; depression (e.g. hopelessness, depressed mood), anxiety (e.g. fear, anticipation of negative events), and stress (e.g. prolonged state of arousal, difficulty relaxing).
Psychological strain
Time frame: Six months following baseline.
The Depression, Anxiety, and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995), a 21-item self-report measure that will assess caregiver's levels of psychological strain over the last week in three distinct categories; depression (e.g. hopelessness, depressed mood), anxiety (e.g. fear, anticipation of negative events), and stress (e.g. prolonged state of arousal, difficulty relaxing).
Psychological strain
Time frame: Twelve months following baseline.
The Depression, Anxiety, and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995), a 21-item self-report measure that will assess caregiver's levels of psychological strain over the last week in three distinct categories; depression (e.g. hopelessness, depressed mood), anxiety (e.g. fear, anticipation of negative events), and stress (e.g. prolonged state of arousal, difficulty relaxing).
Psychological strain
Time frame: Eighteen months following baseline.
The Depression, Anxiety, and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995), a 21-item self-report measure that will assess caregiver's levels of psychological strain over the last week in three distinct categories; depression (e.g. hopelessness, depressed mood), anxiety (e.g. fear, anticipation of negative events), and stress (e.g. prolonged state of arousal, difficulty relaxing).
Psychological strain
Time frame: Twenty four months following baseline.
The Depression, Anxiety, and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995), a 21-item self-report measure that will assess caregiver's levels of psychological strain over the last week in three distinct categories; depression (e.g. hopelessness, depressed mood), anxiety (e.g. fear, anticipation of negative events), and stress (e.g. prolonged state of arousal, difficulty relaxing).
30 secondary outcomes
Caregiver's perception of brain injury services in the community
Time frame: At baseline.
Caregiver's perception of brain injury services in the community
Time frame: Six months following baseline.
Caregiver's perception of brain injury services in the community
Time frame: Twelve months following baseline.
Caregiver's perception of brain injury services in the community
Time frame: Eighteen months following baseline.
Caregiver's perception of brain injury services in the community
Time frame: Twenty four months following baseline.
Social support
Time frame: At baseline.
Social support
Time frame: Six months following baseline.
Social support
Time frame: Twelve months following baseline.
Social support
Time frame: Eighteen months following baseline.
Social support
Time frame: Twenty four months following baseline.
Savouring
Time frame: At baseline.
Savouring
Time frame: Six months following baseline.
Savouring
Time frame: Twelve months following baseline.
Savouring
Time frame: Eighteen months following baseline.
Savouring
Time frame: Twenty four months following baseline.
Overall quality of life and general health
Time frame: At baseline.
Overall quality of life and general health
Time frame: Six months following baseline.
Overall quality of life and general health
Time frame: Twelve months following baseline.
Overall quality of life and general health
Time frame: Eighteen months following baseline.
Overall quality of life and general health
Time frame: Twenty four months following baseline.
Caregiver burden
Time frame: At baseline.
Caregiver burden
Time frame: Six months following baseline.
Caregiver burden
Time frame: Twelve months following baseline.
Caregiver burden
Time frame: Eighteen months following baseline.
Caregiver burden
Time frame: Twenty four months following baseline.
Caregiving self-efficacy
Time frame: At baseline.
Caregiving self-efficacy
Time frame: Six months following baseline.
Caregiving self-efficacy
Time frame: Twelve months following baseline.
Caregiving self-efficacy
Time frame: Eighteen months following baseline.
Caregiving self-efficacy
Time frame: Twenty four months following baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: Yes. Participants will be asked to indicate during Informed Consent whether their de-identified data may be shared with other researchers, provided the study is approved by an ethics board and researchers agree to use the data only for the purposes described in the approved research study. De-identified data from all outcome measures will be made available to approved researchers upon request, provided individual participants have provided consent.
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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.
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 IWK Health Centre 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 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 30 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological strain (time frame: At baseline.). The study lists 5 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 30 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.