LeLaurin Jennifer H, Lamba Avi H, Eliazar-Macke Nathaniel D, Schmitzberger Magda K, Freytes I Magaly, Dang Stuti, Vogel W Bruce, Levy Charles E, Klanchar S Angelina, Beyth Rebecca J, Shorr Ronald I, Uphold Constance R
North Florida/South Georgia Veterans Health System, Gainesville, FL, United States.
Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL, United States.
JMIR Res Protoc. 2020 Nov 11;9(11):e21799. doi: 10.2196/21799.
The majority of stroke survivors return to their homes and need assistance from family caregivers to perform activities of daily living. These increased demands coupled with the lack of preparedness for their new roles lead to a high risk for caregivers developing depressive symptoms and other negative outcomes. Follow-up home support and problem-solving interventions with caregivers are crucial for maintaining stroke survivors in their homes. Problem-solving interventions are effective but are underused in practice because they require large amounts of staff time to implement and are difficult for caregivers logistically.
The aim of this study is to test a problem-solving intervention for stroke caregivers that can be delivered over the telephone during the patient's transitional care period (time when the stroke survivor is discharged to home) followed by 8 asynchronous online sessions.
The design is a two-arm parallel randomized clinical trial with repeated measures. We will enroll 240 caregivers from eight Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive a modified problem-solving intervention that uses telephone and web-based support and training with interactive modules, fact sheets, and tools on the previously developed and nationally available Resources and Education for Stroke Caregivers' Understanding and Empowerment Caregiver website. In the usual care group, no changes are made in the information, discharge planning, or care the patients who have had a stroke normally receive, and caregivers have access to existing VA resources (eg, caregiver support line, self-help materials). The primary outcome is a change in caregiver depressive symptoms at 11 and 19 weeks after baseline data collection. Secondary outcomes include changes in stroke caregivers' burden, knowledge, positive aspects of caregiving, self-efficacy, perceived stress, health-related quality of life, and satisfaction with care and changes in stroke survivors' functional abilities and health care use. The team will also determine the budgetary impact, facilitators, barriers, and best practices for implementing the intervention. Throughout all phases of the study, we will collaborate with members of an advisory panel.
Study enrollment began in June 2015 and is ongoing. The first results are expected to be submitted for publication in 2021.
This is the first known study to test a transitional care and messaging center intervention combined with technology to decrease caregiver depressive symptoms and to improve the recovery of stroke survivors. If successful, findings will support an evidence-based model that can be transported into clinical practice to improve the quality of caregiving post stroke.
ClinicalTrials.gov NCT01600131; https://www.clinicaltrials.gov/ct2/show/NCT01600131.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21799.
大多数中风幸存者会返回家中，需要家庭护理人员协助进行日常生活活动。这些需求的增加，再加上对新角色缺乏准备，导致护理人员出现抑郁症状和其他负面结果的风险很高。对护理人员进行后续家庭支持和问题解决干预对于使中风幸存者居家生活至关重要。问题解决干预是有效的，但在实践中未得到充分利用，因为它们需要大量工作人员时间来实施，并且对护理人员来说在后勤方面存在困难。
本研究的目的是测试一种针对中风护理人员的问题解决干预措施，该措施可在患者过渡护理期间（中风幸存者出院回家的时间段）通过电话提供，随后进行8次异步在线课程。
该设计为双臂平行随机临床试验，采用重复测量。我们将从8个退伍军人事务（VA）医疗中心招募240名护理人员。随机分配到干预组的参与者接受一种改良的问题解决干预，该干预使用电话和基于网络的支持与培训，包括交互式模块、情况说明书以及在先前开发的、全国可用的中风护理人员理解与赋权护理人员网站上的工具。在常规护理组中，对中风患者通常接受的信息、出院计划或护理不做改变，护理人员可使用现有的VA资源（如护理人员支持热线、自助材料）。主要结局是在基线数据收集后11周和19周时护理人员抑郁症状的变化。次要结局包括中风护理人员的负担、知识、护理的积极方面、自我效能感、感知压力、健康相关生活质量、对护理的满意度的变化，以及中风幸存者功能能力和医疗保健使用的变化。研究团队还将确定实施该干预的预算影响、促进因素、障碍和最佳实践。在研究的所有阶段，我们将与一个咨询小组的成员合作。
研究招募于2015年6月开始，目前仍在进行中。预计第一批结果将于2021年提交发表。
这是第一项已知的测试过渡护理和信息中心干预与技术相结合以减少护理人员抑郁症状并改善中风幸存者康复情况的研究。如果成功，研究结果将支持一种可应用于临床实践以提高中风后护理质量的循证模式。
ClinicalTrials.gov NCT01600131；https://www.clinicaltrials.gov/ct2/show/NCT01600131。
国际注册报告识别码（IRRID）：DERR1-10.2196/21799。
