An E-health Letter Intervention for Caregivers

Not Applicable

Recruiting

• Conditions: Caregivers; Acquired Brain Injury

• Registration Number: NCT05882461
• Lead Sponsor: IWK Health Centre

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.

Study Timeline

• Study Start: 2021-02-17
• Study First Submitted: 2021-03-15
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-26
• Last Update Submitted: 2023-05-26
• Study First Posted: 2023-05-31
• Last Update Posted: 2023-05-31
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Caregiving self-efficacy	[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.

Secondary Outcome Measures

Name	Time	Method
Caregiver burden	[Time Frame: Twenty four months following baseline.]	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	[Time Frame: Twenty four months following baseline.]	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.
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).
Overall quality of life and general health	[Time Frame: Twenty four months following baseline.]	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.

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada