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

Caregivers Clinical Trial

— CaringForwrd  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05302245
• Other study ID #: 1025568
• Secondary ID: 1025253
• Status: Recruiting
• Start date: October 30, 2020
• Est. completion date: March 30, 2024

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Brain Injuries
• Caregivers

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
Primary	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).	At baseline.
Primary	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).	Six months following baseline.
Primary	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).	Twelve months following baseline.
Primary	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).	Eighteen months following baseline.
Primary	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).	Twenty four months following baseline.
Secondary	Caregiver's perception of brain injury services in the community	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.	At baseline.
Secondary	Caregiver's perception of brain injury services in the community	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.	Six months following baseline.
Secondary	Caregiver's perception of brain injury services in the community	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.	Twelve months following baseline.
Secondary	Caregiver's perception of brain injury services in the community	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.	Eighteen months following baseline.
Secondary	Caregiver's perception of brain injury services in the community	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.	Twenty four months following baseline.
Secondary	Social support	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.	At baseline.
Secondary	Social support	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.	Six months following baseline.
Secondary	Social support	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.	Twelve months following baseline.
Secondary	Social support	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.	Eighteen months following baseline.
Secondary	Social support	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Twenty four months following baseline.
Secondary	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.	At baseline.
Secondary	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.	Six months following baseline.
Secondary	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.	Twelve months following baseline.
Secondary	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.	Eighteen months following baseline.
Secondary	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.	Twenty four months following baseline.