Levinson Anthony J, Ayers Stephanie, Clark Sandra, Woodburn Rebekah, Markle-Reid Maureen, McKenna Brian, Oliver Doug, Papaioannou Alexandra, Siu Henry, Sztramko Richard
McMaster University, Hamilton, ON, Canada.
Geras Centre for Aging Research, Hamilton, ON, Canada.
JMIR Res Protoc. 2025 Jun 4;14:e67048. doi: 10.2196/67048.
The prevalence of dementia is increasing in Canada and in many countries internationally. People living with dementia are highly dependent on family and friend care partners, who may have little knowledge of the disorder. Web-based interventions in dementia have been shown to improve care partner mental health and reduce burden, but few have been widely implemented or rigorously studied. We developed a web- and email-based dementia education platform for care partners, iGeriCare, which includes 12 asynchronous, multimedia, e-learning lessons and email-based content to reinforce the learning.
The primary objective of this pilot study is to evaluate the feasibility and care partner acceptance of the intervention, including study methods. Secondary objectives will examine the effectiveness of the educational resources on family care partners' knowledge, self-efficacy, and sense of burden.
This study is a 2-arm, pilot, feasibility, randomized controlled trial. A total of 125 family or friend care partners for a person living with dementia-who are residing in Canada, aged 16+ years, and comfortable using the internet and email-will be recruited using coinvestigator networks and Facebook digital marketing advertisements. Participants will be randomly assigned to either the intervention group (receiving the dementia web- and email-based educational intervention) or the control group (receiving an alternate topic e-learning lesson and emails) and will have 8 weeks to complete baseline surveys and the assigned e-learning. After 8 weeks, participants will have 2 weeks to complete poststudy surveys. This protocol will be repeated with a second cohort of 100 care partners recruited from a paid panel service based on learnings from initial feasibility results.
Initial recruitment began on September 6, 2022, and concluded on October 2, 2022. A total of 125 participants were randomly assigned to the intervention (n=61) or control (n=64) group. Data collection concluded in January 2023. Preliminary feasibility results showed a substantial number of participants who did not engage with the protocol as intended. A decision was made to recruit a second cohort of participants to address these protocol deviations. Secondary recruitment began on June 12, 2023, and concluded on June 27, 2023. A total of 100 participants were randomly assigned to the intervention (n=53) or control (n=47) group. Data collection concluded in September 2023. Further results will be published in peer-reviewed journals and presented at conferences.
This study is investigating the feasibility, acceptability, and effectiveness of a web- and email-based dementia care partner educational intervention. The results of this study will contribute to the planning of a larger randomized controlled trial in the future, as well as the evaluation of innovative, cost-effective, and efficient dementia care partner resources that can complement traditional approaches.
ClinicalTrials.gov NCT05114187; https://clinicaltrials.gov/study/NCT05114187.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/67048.
在加拿大及国际上的许多国家，痴呆症的患病率正在上升。痴呆症患者高度依赖家人和朋友等护理伙伴，而这些护理伙伴可能对该疾病知之甚少。基于网络的痴呆症干预措施已被证明可改善护理伙伴的心理健康并减轻负担，但很少有措施得到广泛实施或经过严格研究。我们为护理伙伴开发了一个基于网络和电子邮件的痴呆症教育平台iGeriCare，其中包括12节异步、多媒体电子学习课程以及用于强化学习的电子邮件内容。
这项试点研究的主要目的是评估该干预措施的可行性以及护理伙伴对其的接受程度，包括研究方法。次要目的将考察教育资源对家庭护理伙伴的知识、自我效能感和负担感的有效性。
本研究是一项双臂、试点、可行性随机对照试验。将通过共同研究者网络和脸书数字营销广告招募总共125名加拿大痴呆症患者的家人或朋友护理伙伴，他们年龄在16岁及以上，且习惯使用互联网和电子邮件。参与者将被随机分配到干预组（接受基于网络和电子邮件的痴呆症教育干预）或对照组（接受另一个主题的电子学习课程和电子邮件），并有8周时间完成基线调查和指定的电子学习。8周后，参与者将有2周时间完成研究后调查。将根据初步可行性结果从付费面板服务中招募第二批100名护理伙伴，重复此方案。
首次招募于2022年9月6日开始，于2022年10月2日结束。总共125名参与者被随机分配到干预组（n = 61）或对照组（n = 64）。数据收集于2023年1月结束。初步可行性结果显示，大量参与者未按预期参与方案。因此决定招募第二批参与者以解决这些方案偏差问题。二次招募于2023年6月12日开始，于2023年6月27日结束。总共100名参与者被随机分配到干预组（n = 53）或对照组（n = 47）。数据收集于2023年9月结束。进一步的结果将在同行评审期刊上发表并在会议上展示。
本研究正在调查基于网络和电子邮件的痴呆症护理伙伴教育干预措施的可行性、可接受性和有效性。本研究结果将有助于未来规划更大规模的随机对照试验，以及评估可补充传统方法的创新、经济高效的痴呆症护理伙伴资源。
ClinicalTrials.gov NCT05114187；https://clinicaltrials.gov/study/NCT05114187。
国际注册报告识别码（IRRID）：DERR1-10.2196/67048。
