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An E-health Letter Intervention for Caregivers (90Second)

Primary Purpose

Caregivers, Acquired Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
90Second Caregiver health letter
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caregivers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • IWK Health CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Those receiving the 90Second Caregiver health letter

The usual care control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 15, 2021
Last Updated
May 26, 2023
Sponsor
IWK Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05882461
Brief Title
An E-health Letter Intervention for Caregivers
Acronym
90Second
Official Title
90Second Caregiver: A Randomized Control Trial of an E-health Letter for Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IWK Health Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregivers, Acquired Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
In sequence of eligibility, participants will be randomized to the treatment arm or the control arm, with a 1:1 allocation ratio stratified by gender. The randomization sequence will be generated by a trained person that is not related to the study participants in any way. The investigators and study staff will be blinded to the randomization sequence until the end of the study. Participant randomization will be performed in REDCap. REDCap maintains an automated audit trail which includes the assigned study identification number, treatment allocation, and date and time of the allocation assignment.
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Those receiving the 90Second Caregiver health letter
Arm Type
Experimental
Arm Description
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.
Arm Title
The usual care control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
90Second Caregiver health letter
Intervention Description
Participant receives the weekly health letter via email
Primary Outcome Measure Information:
Title
Caregiving self-efficacy
Description
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.
Time Frame
[Time Frame: At baseline.]
Title
Caregiving self-efficacy
Description
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.
Time Frame
[Time Frame: Six months following baseline.]
Title
Caregiving self-efficacy
Description
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.
Time Frame
[Time Frame: Twelve months following baseline.]
Title
Caregiving self-efficacy
Description
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.
Time Frame
[Time Frame: Eighteen months following baseline.]
Title
Caregiving self-efficacy
Description
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.
Time Frame
[Time Frame: Twenty four months following baseline.]
Secondary Outcome Measure Information:
Title
Psychological strain
Description
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).
Time Frame
[Time Frame: At baseline.]
Title
Psychological strain
Description
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).
Time Frame
[Time Frame: Six months following baseline.]
Title
Psychological strain
Description
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).
Time Frame
[Time Frame: Twelve months following baseline.]
Title
Psychological strain
Description
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).
Time Frame
[Time Frame: Eighteen months following baseline.]
Title
Psychological strain
Description
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).
Time Frame
[Time Frame: Twenty four months following baseline.]
Title
Caregiver burden
Description
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.
Time Frame
[Time Frame: At baseline.]
Title
Caregiver burden
Description
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.
Time Frame
[Time Frame: Six months following baseline.]
Title
Caregiver burden
Description
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.
Time Frame
[Time Frame: Twelve months following baseline.]
Title
Caregiver burden
Description
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.
Time Frame
[Time Frame: Eighteen months following baseline.]
Title
Caregiver burden
Description
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.
Time Frame
[Time Frame: Twenty four months following baseline.]
Title
Savouring
Description
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.
Time Frame
[Time Frame: At baseline.]
Title
Savouring
Description
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.
Time Frame
[Time Frame: Six months following baseline.]
Title
Savouring
Description
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.
Time Frame
[Time Frame: Twelve months following baseline.]
Title
Savouring
Description
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.
Time Frame
[Time Frame: Eighteen months following baseline.]
Title
Savouring
Description
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.
Time Frame
[Time Frame: Twenty four months following baseline.]
Title
Overall quality of life and general health
Description
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.
Time Frame
[Time Frame: At baseline.]
Title
Overall quality of life and general health
Description
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.
Time Frame
[Time Frame: Six months following baseline.]
Title
Overall quality of life and general health
Description
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.
Time Frame
[Time Frame: Twelve months following baseline.]
Title
Overall quality of life and general health
Description
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.
Time Frame
[Time Frame: Eighteen months following baseline.]
Title
Overall quality of life and general health
Description
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.
Time Frame
[Time Frame: Twenty four months following baseline.]
Other Pre-specified Outcome Measures:
Title
Usability of the 90Second Caregiver health letter
Description
The current study will also assess the usability of the 90Second Caregiver health letter by evaluating the relevance of topic, learnability, and acceptability of the program. The usability questionnaire was developed for the current study.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Lauzon
Phone
(902) 470-8160
Email
Andre.Lauzon@iwk.nshealth.ca
First Name & Middle Initial & Last Name & Degree
Patrick McGrath

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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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An E-health Letter Intervention for Caregivers

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