Clinical trial NCT05302245: A Longitudinal Examination of Unpaid Caregivers of Acquired Brain Injury (ABI) Survivors in Nova Scotia
Official title: Caring Forward: A Longitudinal Examination of Unpaid Caregivers of Acquired Brain Injury (ABI) Survivors in Nova Scotia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Caregivers
Keywords: Caregivers
Acquired brain injury
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caregivers of ABI survivors living in Nova Scotia.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Psychological strain
timeFrame: At baseline.
measure: Psychological strain
timeFrame: Six months following baseline.
measure: Psychological strain
timeFrame: Twelve months following baseline.
measure: Psychological strain
timeFrame: Eighteen months following baseline.
measure: Psychological strain
timeFrame: Twenty four months following baseline.
Secondary outcomes:
measure: Caregiver's perception of brain injury services in the community
timeFrame: At baseline.
measure: Caregiver's perception of brain injury services in the community
timeFrame: Six months following baseline.
measure: Caregiver's perception of brain injury services in the community
timeFrame: Twelve months following baseline.
measure: Caregiver's perception of brain injury services in the community
timeFrame: Eighteen months following baseline.
measure: Caregiver's perception of brain injury services in the community
timeFrame: Twenty four months following baseline.
measure: Social support
timeFrame: At baseline.
measure: Social support
timeFrame: Six months following baseline.
measure: Social support
timeFrame: Twelve months following baseline.
measure: Social support
timeFrame: Eighteen months following baseline.
measure: Social support
timeFrame: Twenty four months following baseline.
measure: Savouring
timeFrame: At baseline.
measure: Savouring
timeFrame: Six months following baseline.
measure: Savouring
timeFrame: Twelve months following baseline.
measure: Savouring
timeFrame: Eighteen months following baseline.
measure: Savouring
timeFrame: Twenty four months following baseline.
measure: Overall quality of life and general health
timeFrame: At baseline.
measure: Overall quality of life and general health
timeFrame: Six months following baseline.
measure: Overall quality of life and general health
timeFrame: Twelve months following baseline.
measure: Overall quality of life and general health
timeFrame: Eighteen months following baseline.
measure: Overall quality of life and general health
timeFrame: Twenty four months following baseline.
measure: Caregiver burden
timeFrame: At baseline.
measure: Caregiver burden
timeFrame: Six months following baseline.
measure: Caregiver burden
timeFrame: Twelve months following baseline.
measure: Caregiver burden
timeFrame: Eighteen months following baseline.
measure: Caregiver burden
timeFrame: Twenty four months following baseline.
measure: Caregiving self-efficacy
timeFrame: At baseline.
measure: Caregiving self-efficacy
timeFrame: Six months following baseline.
measure: Caregiving self-efficacy
timeFrame: Twelve months following baseline.
measure: Caregiving self-efficacy
timeFrame: Eighteen months following baseline.
measure: Caregiving self-efficacy
timeFrame: Twenty four months following baseline.
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
References: