Department of Psychiatry and Neuropsychology and Alzheimer Center Limburg, School for Mental Health and Neuroscience (MHeNS), Maastricht University, PO Box 6166200 MD, Maastricht, The Netherlands.
Department of Clinical Neuropsychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Trials. 2023 Jun 22;24(1):427. doi: 10.1186/s13063-023-07423-9.
Informal caregivers of people with dementia are crucial in dementia care. However, they are insufficiently supported and report caregiver burdens, which urges the need for cost-effective interventions aimed at supporting caregivers. This paper presents the design of a study evaluating the effectiveness, cost-effectiveness, and cost-utility of a blended self-management program for early-stage dementia caregivers.
METHODS/DESIGN: A pragmatic, cluster randomized controlled trial with a shared control group will be conducted. Participants will be informal caregivers of people with early-stage dementia and will be recruited by local care professionals. Randomization will be carried out at the level of the care professional level in a ratio of 35% to 65% (control arm vs. intervention arm). Participants in the control arm will receive care as usual and the intervention arm will receive the blended care self-management program "Partner in Balance" within a usual care setting in the Netherlands. Data will be collected at baseline and at 3-, 6-, 12-, and 24-month follow-ups. The primary outcome for effectiveness (part 1) is care management self-efficacy. For the health-economic evaluation (part 2) total care costs and the quality of life for individuals with dementia (cost-effectiveness) and quality-adjusted life years (cost-utility) will be the base case analysis. Secondary outcomes (parts 1 and 2) will include depression, anxiety, perceived informal caregiving stress, service-use self-efficacy, quality of life, caregivers' gain, and perseverance time. A process evaluation (part 3) will investigate the internal and external validity of the intervention.
In this trial, we plan to evaluate the effectiveness, cost-effectiveness, and cost-utility of "Partner in Balance" among informal caregivers of people with dementia. We expect to find a significant increase in care management self-efficacy, and the program to be cost-effective, and provide valuable insights to stakeholders of "Partner in Balance."
ClinicalTrials.gov, NCT05450146. Registered on 4 November 2022.
痴呆症患者的非专业照护者在痴呆症照护中至关重要。然而，他们的支持不足，并报告了照护者负担，这迫切需要针对照护者的具有成本效益的干预措施。本文介绍了一项评估早期痴呆症照护者混合自我管理计划的有效性、成本效益和成本效用的研究设计。
方法/设计：将开展一项实用的、集群随机对照试验，并设立共享对照组。参与者将是非专业的早期痴呆症患者的照护者，并通过当地照护专业人员进行招募。将按照 35%到 65%的比例（对照组与干预组）在照护专业人员层面进行随机分组。对照组将接受常规照护，而干预组将在荷兰的常规照护环境中接受混合自我管理计划“平衡伙伴”。数据将在基线和 3、6、12 和 24 个月的随访时收集。有效性（第 1 部分）的主要结局指标是照护管理自我效能感。对于健康经济学评估（第 2 部分），总成本和痴呆症患者的生活质量（成本效益）和质量调整生命年（成本效用）将作为基准分析。次要结局指标（第 1 部分和第 2 部分）将包括抑郁、焦虑、感知的非正式照护压力、服务使用自我效能感、生活质量、照护者获益和坚持时间。过程评估（第 3 部分）将调查干预措施的内部和外部有效性。
在这项试验中，我们计划评估“平衡伙伴”对痴呆症患者的非专业照护者的有效性、成本效益和成本效用。我们预计会发现照护管理自我效能感显著增加，且该计划具有成本效益，并为“平衡伙伴”的利益相关者提供有价值的见解。
ClinicalTrials.gov，NCT05450146。于 2022 年 11 月 4 日注册。
