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

NCT05302245 | Unknown

• 2 other identifiers: 10255681025253
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.To learn about the relationship between psychological outcome variables (e.g. psychological distress and savouring).
4. 4.To provide a platform for future studies using the Trials within Cohort (TwiC) study design.

Conditions

Caregivers

Keywords

Caregivers; Acquired brain injury

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (30)

• Caregiver's perception of brain injury services in the community

  At baseline.

• Caregiver's perception of brain injury services in the community

  Six months following baseline.

• Caregiver's perception of brain injury services in the community

  Twelve months following baseline.

• Caregiver's perception of brain injury services in the community

  Eighteen months following baseline.

• Caregiver's perception of brain injury services in the community

  Twenty four months following baseline.

Study Arms (1)

Caregivers of ABI survivors

Unpaid caregivers of acquired brain injury survivors living in Nova Scotia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caregivers of ABI survivors living in Nova Scotia.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, Canada

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 31, 2022
• Study Start: October 30, 2020
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CA (1)