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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05302245
Other study ID # 1025568
Secondary ID 1025253
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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.
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