A Longitudinal Examination of Unpaid Caregivers of Acquired Brain Injury (ABI) Survivors in Nova Scotia

Recruiting

• Conditions: Caregivers

• Registration Number: NCT05302245
• Lead Sponsor: IWK Health Centre

Brief 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). 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:

1. 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.

2. 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).

3. To learn about the relationship between psychological outcome variables (e.g. psychological distress and savouring).

4. 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 Timeline

• Study Start: 2020-10-30
• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-03-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychological strain	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).

Secondary Outcome Measures

Name	Time	Method
Social support	Twenty four months following baseline.	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.
Caregiver burden	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.
Caregiving self-efficacy	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.
Caregiver's perception of brain injury services in the community	Twenty four months following baseline.	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.
Savouring	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.
Overall quality of life and general health	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