Clinical trial NCT05882461: An E-health Letter Intervention for Caregivers
Official title: 90Second Caregiver: A Randomized Control Trial of an E-health Letter for Caregivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caregivers
Acquired Brain Injury
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will conduct a two-arm Randomized Control Trial (RCT), comparing a group assigned to receive the 90Second Caregiver Caregiver health letter, with a usual care control group.
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to conduct a two-arm Randomized Control Trial (RCT) comparing individuals receiving the 90Second Caregiver health letter, with a usual care (routine care received by caregivers) control group.

The goals of the present study are:

* To evaluate the effectiveness of the 90Second Caregiver health letter in improving caregiver's self-efficacy (primary outcome), savouring, and quality of life (secondary outcomes).
* To evaluate the effectiveness of the 90Second Caregiver health letter in reducing caregiver's psychological strain and caregiver burden (secondary outcomes).
* To examine the impact of levels of engagement with the 90Second Caregiver health letter on primary and secondary outcomes.
* To assess the usability of the 90Second Caregiver health letter, as it relates to the relevance of topic, user friendliness, and appropriateness of the readability levels.
* To evaluate psychometric properties of self-constructed measures in 90Second newsletter.

Detailed description: The present study will examine the effectiveness of the 90Second Caregiver health letter in increasing self-efficacy in a sample of informal caregivers of ABI survivors in Nova Scotia. Participants in this study will be recruited from the Caring Forward Trials within Cohort Study (REB#1025253). The study is funded by the Nova Scotia Department of Health and Wellness.

Eligibility criteria: Inclusion Criteria:

* Participant is currently enrolled in the Caring Forward Trials within Cohort study (REB#1025253)
* Participant has agreed to be contacted for future studies by Dr. McGrath's staff
* Participant has agreed for their data to be used for future studies
* Participant has mild levels of distress, as indicated by mild scores on the DASS-21 and/or the ZBI-SF

Exclusion Criteria:

* Participant is NOT currently enrolled in the Caring Forward Trials within Cohort study (REB#1025253)
* Participant has NOT agreed to be contacted for future studies by Dr. McGrath's staff
* Participant has NOT agreed for their data to be used in future studies
* Participant does NOT report mild levels of distress, as indicated by mild scores on the DASS-21 and/or the ZBI-SF

Primary outcomes:
measure: Caregiving self-efficacy
timeFrame: [Time Frame: At baseline.]
measure: Caregiving self-efficacy
timeFrame: [Time Frame: Six months following baseline.]
measure: Caregiving self-efficacy
timeFrame: [Time Frame: Twelve months following baseline.]
measure: Caregiving self-efficacy
timeFrame: [Time Frame: Eighteen months following baseline.]
measure: Caregiving self-efficacy
timeFrame: [Time Frame: Twenty four months following baseline.]
Secondary outcomes:
measure: Psychological strain
timeFrame: [Time Frame: At baseline.]
measure: Psychological strain
timeFrame: [Time Frame: Six months following baseline.]
measure: Psychological strain
timeFrame: [Time Frame: Twelve months following baseline.]
measure: Psychological strain
timeFrame: [Time Frame: Eighteen months following baseline.]
measure: Psychological strain
timeFrame: [Time Frame: Twenty four months following baseline.]
measure: Caregiver burden
timeFrame: [Time Frame: At baseline.]
measure: Caregiver burden
timeFrame: [Time Frame: Six months following baseline.]
measure: Caregiver burden
timeFrame: [Time Frame: Twelve months following baseline.]
measure: Caregiver burden
timeFrame: [Time Frame: Eighteen months following baseline.]
measure: Caregiver burden
timeFrame: [Time Frame: Twenty four months following baseline.]
measure: Savouring
timeFrame: [Time Frame: At baseline.]
measure: Savouring
timeFrame: [Time Frame: Six months following baseline.]
measure: Savouring
timeFrame: [Time Frame: Twelve months following baseline.]
measure: Savouring
timeFrame: [Time Frame: Eighteen months following baseline.]
measure: Savouring
timeFrame: [Time Frame: Twenty four months following baseline.]
measure: Overall quality of life and general health
timeFrame: [Time Frame: At baseline.]
measure: Overall quality of life and general health
timeFrame: [Time Frame: Six months following baseline.]
measure: Overall quality of life and general health
timeFrame: [Time Frame: Twelve months following baseline.]
measure: Overall quality of life and general health
timeFrame: [Time Frame: Eighteen months following baseline.]
measure: Overall quality of life and general health
timeFrame: [Time Frame: Twenty four months following baseline.]
Other outcomes:
measure: Usability of the 90Second Caregiver health letter
timeFrame: through study completion, an average of 1 year
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
References: