90Second Caregiver: A Randomized Control Trial of an E-health Letter for Caregivers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- IWK Health Centre
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- Caregiving self-efficacy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
In sequence of eligibility, participants will be randomized to the treatment arm or the control arm, with a 1:1 allocation ratio stratified by gender. The randomization sequence will be generated by a trained person that is not related to the study participants in any way. The investigators and study staff will be blinded to the randomization sequence until the end of the study. Participant randomization will be performed in REDCap. REDCap maintains an automated audit trail which includes the assigned study identification number, treatment allocation, and date and time of the allocation assignment.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Caregiving self-efficacy
Time Frame: [Time Frame: Twenty four months following baseline.]
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.
Secondary Outcomes
- Savouring([Time Frame: Twenty four months following baseline.])
- Psychological strain([Time Frame: Twenty four months following baseline.])
- Caregiver burden([Time Frame: Twenty four months following baseline.])
- Overall quality of life and general health([Time Frame: Twenty four months following baseline.])
Investigators
Patrick J. McGrath
Principal Investigator
IWK Health Centre