An E-health Letter Intervention for Caregivers

Acquired Brain Injury Clinical Trial

— 90Second  

Official title:

90Second Caregiver: A Randomized Control Trial of an E-health Letter for Caregivers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05882461
• Other study ID #: 1025834
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: March 2024

Study information

• Verified date: May 2023
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Caregivers

Intervention

Behavioral:
• 90Second Caregiver health letter
Participant receives the weekly health letter via email

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Usability of the 90Second Caregiver health letter	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.	through study completion, an average of 1 year
Primary	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.	[Time Frame: At baseline.]
Primary	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.	[Time Frame: Six months following baseline.]
Primary	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.	[Time Frame: Twelve months following baseline.]
Primary	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.	[Time Frame: Eighteen months following baseline.]
Primary	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.	[Time Frame: Twenty four months following baseline.]
Secondary	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).	[Time Frame: At baseline.]
Secondary	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).	[Time Frame: Six months following baseline.]
Secondary	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).	[Time Frame: Twelve months following baseline.]
Secondary	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).	[Time Frame: Eighteen months following baseline.]
Secondary	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).	[Time Frame: Twenty four months following baseline.]
Secondary	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.	[Time Frame: At baseline.]
Secondary	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.	[Time Frame: Six months following baseline.]
Secondary	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.	[Time Frame: Twelve months following baseline.]
Secondary	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.	[Time Frame: Eighteen months following baseline.]
Secondary	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.	[Time Frame: Twenty four months following baseline.]
Secondary	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.	[Time Frame: At baseline.]
Secondary	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.	[Time Frame: Six months following baseline.]
Secondary	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.	[Time Frame: Twelve months following baseline.]
Secondary	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.	[Time Frame: Eighteen months following baseline.]
Secondary	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.	[Time Frame: Twenty four months following baseline.]
Secondary	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.	[Time Frame: At baseline.]
Secondary	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.	[Time Frame: Six months following baseline.]
Secondary	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.	[Time Frame: Twelve months following baseline.]
Secondary	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.	[Time Frame: Eighteen months following baseline.]
Secondary	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.	[Time Frame: Twenty four months following baseline.]