Caregivers90SecondNCT05882461
An E-health Letter Intervention for Caregivers
A study testing 90Second Caregiver health letter in people with Caregivers and Acquired Brain Injury, run by IWK Health Centre at 1 site in Canada.
Trial summary
The purpose of the present study is to conduct a two-arm Randomized Control Trial (RCT) comparing individuals receiving the 90Second Caregiver health letter, with a usual care (routine care received by caregivers) control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregivers, Acquired Brain Injury
- What is being tested?
- 90Second Caregiver health letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteCanada
- Study dates
- 17 Feb 2021to Mar 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is currently enrolled in the Caring Forward Trials within Cohort study (REB#1025253)
- Participant has agreed to be contacted for future studies by Dr. McGrath's staff
- Participant has agreed for their data to be used for future studies
- Participant has mild levels of distress, as indicated by mild scores on the DASS-21 and/or the ZBI-SF
Who cannot join
- Participant is NOT currently enrolled in the Caring Forward Trials within Cohort study (REB#1025253)
- Participant has NOT agreed to be contacted for future studies by Dr. McGrath's staff
- Participant has NOT agreed for their data to be used in future studies
- Participant does NOT report mild levels of distress, as indicated by mild scores on the DASS-21 and/or the ZBI-SF
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: 90Second Caregiver: A Randomized Control Trial of an E-health Letter for Caregivers
The purpose of the present study is to conduct a two-arm Randomized Control Trial (RCT) comparing individuals receiving the 90Second Caregiver health letter, with a usual care (routine care received by caregivers) control group.
The goals of the present study are:
- To evaluate the effectiveness of the 90Second Caregiver health letter in improving caregiver's self-efficacy (primary outcome), savouring, and quality of life (secondary outcomes).
- To evaluate the effectiveness of the 90Second Caregiver health letter in reducing caregiver's psychological strain and caregiver burden (secondary outcomes).
- To examine the impact of levels of engagement with the 90Second Caregiver health letter on primary and secondary outcomes.
- To assess the usability of the 90Second Caregiver health letter, as it relates to the relevance of topic, user friendliness, and appropriateness of the readability levels.
- To evaluate psychometric properties of self-constructed measures in 90Second newsletter.
Read the detailed description
The present study will examine the effectiveness of the 90Second Caregiver health letter in increasing self-efficacy in a sample of informal caregivers of ABI survivors in Nova Scotia. Participants in this study will be recruited from the Caring Forward Trials within Cohort Study (REB#1025253). The study is funded by the Nova Scotia Department of Health and Wellness.
- Conditions
- Caregivers, Acquired Brain Injury
- Being tested
- 90Second Caregiver health letter
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90Second Caregiver health letterBehavioural
Participant receives the weekly health letter via email
| Study group | Role | What they receive |
|---|---|---|
| Those receiving the 90Second Caregiver health letter | Experimental | The 90Second Caregiver health letter is a weekly online publication that addresses topics relevant for caregivers. It combines scientifically-valid, evidence-based information with actionable tips to improve caregiver self efficacy and well-being. Participant in this group will receive a 90Second Caregiver health letter every week, via email. Receives: Behavioral: 90Second Caregiver health letter |
| The usual care control group | No intervention | Participants that are randomized to be in the usual care control group will continue on as participants in the Caring Forward Trials within Cohort Study (i.e. filling out questionnaires every 6-months). Participants will continue to participate in the Caring Forward Study until completion in March 2022. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: Twenty four months following baseline.]
Secondary outcomes (20)
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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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 May 2023
- Study start17 Feb 2021
- Primary completionMar 2024 (estimated)
- Study completionMar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will conduct a two-arm Randomized Control Trial (RCT), comparing a group assigned to receive the 90Second Caregiver Caregiver health letter, with a usual care control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 330 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
- NCT05882461
- Sponsor's protocol ID
- 1025834
- Acronym
- 90Second
- Status last verified
- May 2023
- First submitted
- 15 Mar 2021
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 90Second Caregiver: A Randomized Control Trial of an E-health Letter for Caregivers
- ClinicalTrials.gov ID
- NCT05882461
- Acronym / sponsor ID
- 90Second / 1025834
- Conditions
- Caregivers, Acquired Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 31 May 2023 (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 conduct a two-arm Randomized Control Trial (RCT) comparing individuals receiving the 90Second Caregiver health letter, with a usual care (routine care received by caregivers) control group.
The goals of the present study are:
- To evaluate the effectiveness of the 90Second Caregiver health letter in improving caregiver's self-efficacy (primary outcome), savouring, and quality of life (secondary outcomes).
- To evaluate the effectiveness of the 90Second Caregiver health letter in reducing caregiver's psychological strain and caregiver burden (secondary outcomes).
- To examine the impact of levels of engagement with the 90Second Caregiver health letter on primary and secondary outcomes.
- To assess the usability of the 90Second Caregiver health letter, as it relates to the relevance of topic, user friendliness, and appropriateness of the readability levels.
- To evaluate psychometric properties of self-constructed measures in 90Second newsletter.
Detailed description
The present study will examine the effectiveness of the 90Second Caregiver health letter in increasing self-efficacy in a sample of informal caregivers of ABI survivors in Nova Scotia. Participants in this study will be recruited from the Caring Forward Trials within Cohort Study (REB#1025253). The study is funded by the Nova Scotia Department of Health and Wellness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will conduct a two-arm Randomized Control Trial (RCT), comparing a group assigned to receive the 90Second Caregiver Caregiver health letter, with a usual care control group.
| Arm | Type | Receives |
|---|---|---|
| Those receiving the 90Second Caregiver health letter | Experimental | Behavioral: 90Second Caregiver health letterThe 90Second Caregiver health letter is a weekly online publication that addresses topics relevant for caregivers. It combines scientifically-valid, evidence-based information with actionable tips to improve caregiver self efficacy and well-being. Participant in this group will receive a 90Second Caregiver health letter every week, via email. |
| The usual care control group | No intervention | –Participants that are randomized to be in the usual care control group will continue on as participants in the Caring Forward Trials within Cohort Study (i.e. filling out questionnaires every 6-months). Participants will continue to participate in the Caring Forward Study until completion in March 2022. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is currently enrolled in the Caring Forward Trials within Cohort study (REB#1025253)
- Participant has agreed to be contacted for future studies by Dr. McGrath's staff
- Participant has agreed for their data to be used for future studies
- Participant has mild levels of distress, as indicated by mild scores on the DASS-21 and/or the ZBI-SF
Key exclusion criteria (4 listed)
- Participant is NOT currently enrolled in the Caring Forward Trials within Cohort study (REB#1025253)
- Participant has NOT agreed to be contacted for future studies by Dr. McGrath's staff
- Participant has NOT agreed for their data to be used in future studies
- Participant does NOT report mild levels of distress, as indicated by mild scores on the DASS-21 and/or the ZBI-SF
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 |
|---|---|---|
| 90Second Caregiver health letterParticipant receives the weekly health letter via email | Behavioural | Those receiving the 90Second Caregiver health letter |
Primary outcome
Caregiving self-efficacy
Time frame: [Time Frame: At baseline.]
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.
Caregiving self-efficacy
Time frame: [Time Frame: Six months following baseline.]
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.
Caregiving self-efficacy
Time frame: [Time Frame: Twelve months following baseline.]
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.
Caregiving self-efficacy
Time frame: [Time Frame: Eighteen months following baseline.]
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.
Caregiving self-efficacy
Time frame: [Time Frame: Twenty four months following baseline.]
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.
20 secondary outcomes
Psychological strain
Time frame: [Time Frame: At baseline.]
Psychological strain
Time frame: [Time Frame: Six months following baseline.]
Psychological strain
Time frame: [Time Frame: Twelve months following baseline.]
Psychological strain
Time frame: [Time Frame: Eighteen months following baseline.]
Psychological strain
Time frame: [Time Frame: Twenty four months following baseline.]
Caregiver burden
Time frame: [Time Frame: At baseline.]
Caregiver burden
Time frame: [Time Frame: Six months following baseline.]
Caregiver burden
Time frame: [Time Frame: Twelve months following baseline.]
Caregiver burden
Time frame: [Time Frame: Eighteen months following baseline.]
Caregiver burden
Time frame: [Time Frame: Twenty four months following baseline.]
Savouring
Time frame: [Time Frame: At baseline.]
Savouring
Time frame: [Time Frame: Six months following baseline.]
Savouring
Time frame: [Time Frame: Twelve months following baseline.]
Savouring
Time frame: [Time Frame: Eighteen months following baseline.]
Savouring
Time frame: [Time Frame: Twenty four months following baseline.]
Overall quality of life and general health
Time frame: [Time Frame: At baseline.]
Overall quality of life and general health
Time frame: [Time Frame: Six months following baseline.]
Overall quality of life and general health
Time frame: [Time Frame: Twelve months following baseline.]
Overall quality of life and general health
Time frame: [Time Frame: Eighteen months following baseline.]
Overall quality of life and general health
Time frame: [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 31 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?
A study testing 90Second Caregiver health letter in people with Caregivers and Acquired Brain Injury, 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 4 inclusion and 4 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 31 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?
Caregiving self-efficacy (time frame: [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 31 May 2023.