Resources for Enhancing Alzheimer's Caregiver Health in Vietnam (REACH VN): study protocol for a cluster randomized controlled trial to test the efficacy of a family dementia caregiver intervention in Vietnam.
Resources for Enhancing Alzheimer's Caregiver Health in Vietnam (REACH VN): study protocol for a cluster randomized controlled trial to test the efficacy of a family dementia caregiver intervention in Vietnam.
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由于人口迅速老龄化，阿尔茨海默病和相关痴呆症（AD/ADRD）对越南来说是一个公共卫生挑战。然而，很少有基于社区的项目来支持 AD/ADRD 患者及其家庭护理人员。越南增强阿尔茨海默病护理人员健康资源 (REACH VN) 是一种适应文化的家庭护理人员干预措施，试点研究表明，初步疗效是可行且有希望的。我们描述了一项更大的整群随机对照试验 (RCT) 的方案，以测试 REACH VN 对越南河内以外半农村地区痴呆症患者家庭护理人员的有效性。拥有约 350 名护理人员的 32 个集群将被随机分配接受 REACH VN 干预或强化常规护理。 REACH VN 是一种在 2 至 3 个月的时间内在家中或通过电话提供的多成分干预措施。要符合资格，家庭护理人员必须年满 18 岁，是为痴呆症患者提供最多日常护理的人，并且在 Zarit Burden Interview-4 中得分 ≥ 6。主要结局是护理人员负担（Zarit Burden Interview-12）和心理困扰（患者健康调查问卷-4）。次要结果包括护理人员的躯体症状（患者健康问卷-15）和感知压力（感知压力量表-10）。这些结果将在基线、3 个月和 6 个月时进行评估。还计划进行探索性分析，以检查主要结果的潜在中介因素。据我们所知，这是越南第一项测试基于社区的家庭痴呆症护理人员干预效果的大规模研究。这项研究的结果将有助于为在越南和其他低收入和中等收入国家 (LMIC) 广泛实施 REACH VN 干预措施或类似的基于社区的家庭痴呆症护理人员支持计划提供信息。临床试验.govNCT04542317。注册日期：2020年9月9日
Alzheimer’s disease and related dementias (AD/ADRD) are a public health challenge for Vietnam because of its rapidly aging population. However, very few community-based programs exist to support people living with AD/ADRD and their family caregivers. Resources for Enhancing Alzheimer’s Caregiver Health in Vietnam (REACH VN) is a culturally adapted family caregiver intervention shown in a pilot study to be feasible and promising in terms of preliminary efficacy. We describe the protocol for a larger cluster randomized controlled trial (RCT) to test the efficacy of REACH VN among family caregivers of people living with dementia in a semi-rural area outside of Hanoi, Vietnam. Thirty-two clusters with approximately 350 caregivers will be randomized to either REACH VN intervention or enhanced usual care. REACH VN is a multicomponent intervention delivered in-home or by phone over the course of 2 to 3 months. To be eligible, family caregivers need to be ≥18 years old, be the person who provides the most day-to-day care for people living with dementia, and have a score ≥ 6 on the Zarit Burden Interview-4. The primary outcomes are caregiver burden (Zarit Burden Interview-12) and psychological distress (Patient Health Questionnaire-4). Secondary outcomes include caregiver somatic symptoms (Patient Health Questionnaire-15) and perceived stress (Perceived Stress Scale-10). These outcomes will be assessed at baseline, 3 months, and 6 months. Exploratory analyses to examine potential mediators of primary outcomes are also planned. To our knowledge, this is the first large-scale study to test the efficacy of a community-based family dementia caregiver intervention in Vietnam. Results from this study will help inform efforts to widely deliver the REACH VN intervention or similar community-based family dementia caregiver support programs in Vietnam and other low- and middle-income countries (LMIC). ClinicalTrials.govNCT04542317. Registered on 9 September 2020