90Second Caregiver: A Randomized Control Trial of an E-health Letter for Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Caregiving self-efficacy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Those receiving the 90Second Caregiver health letter
The 90Second Caregiver health letter is a weekly online publication that addresses topics relevant for caregivers. It combines scientifically-valid, evidence-based information with actionable tips to improve caregiver self efficacy and well-being. Participant in this group will receive a 90Second Caregiver health letter every week, via email.
干预措施: 90Second Caregiver health letter (Behavioral)
The usual care control group
Participants that are randomized to be in the usual care control group will continue on as participants in the Caring Forward Trials within Cohort Study (i.e. filling out questionnaires every 6-months). Participants will continue to participate in the Caring Forward Study until completion in March 2022.
结局指标
主要结局
Caregiving self-efficacy
时间窗: [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.
Caregiving self-efficacy
时间窗: [Time Frame: At 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.
Caregiving self-efficacy
时间窗: [Time Frame: Six 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.
Caregiving self-efficacy
时间窗: [Time Frame: Twelve 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.
Caregiving self-efficacy
时间窗: [Time Frame: Eighteen 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.
次要结局
- 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.])
- Psychological strain([Time Frame: At baseline.])
- Psychological strain([Time Frame: Six months following baseline.])
- Psychological strain([Time Frame: Twelve months following baseline.])
- Psychological strain([Time Frame: Eighteen months following baseline.])
- Caregiver burden([Time Frame: At baseline.])
- Caregiver burden([Time Frame: Six months following baseline.])
- Caregiver burden([Time Frame: Twelve months following baseline.])
- Caregiver burden([Time Frame: Eighteen months following baseline.])
- Savouring([Time Frame: At baseline.])
- Savouring([Time Frame: Six months following baseline.])
- Savouring([Time Frame: Twelve months following baseline.])
- Savouring([Time Frame: Eighteen months following baseline.])
- Overall quality of life and general health([Time Frame: At baseline.])
- Overall quality of life and general health([Time Frame: Six months following baseline.])
- Overall quality of life and general health([Time Frame: Twelve months following baseline.])
- Overall quality of life and general health([Time Frame: Eighteen months following baseline.])
研究者
Patrick J. McGrath
Principal Investigator
IWK Health Centre