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一种针对痴呆症患者及其护理伙伴诊断后早期的实时视频复原力二元干预:痴呆症共同复原力开放试点方案。

A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-Partners Early After Diagnosis: Protocol for Open Pilot of Resilient Together for Dementia.

作者信息

McCage Sydney, Walker Kristin, Cornelius Talea, Parker Robert A, Dams-O'Connor Kristen, Dickerson Brad, Ritchie Christine, Vranceanu Ana-Maria, Bannon Sarah

机构信息

Brain Injury Research Center, Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY, United States.

Department of Psychology, Stony Brook University, Stony Brook, NY, United States.

出版信息

JMIR Res Protoc. 2025 Jan 15;14:e60382. doi: 10.2196/60382.

Abstract

BACKGROUND

Alzheimer disease and related dementias (ADRDs) are increasingly common progressive conditions that have a substantial impact on individuals and their primary care partners-together described as a dyad. The stressors experienced by dyad members at around the time of ADRD diagnosis commonly produce clinically elevated emotional distress (ie, depression and anxiety symptoms), which can become chronic and negatively impact health, relationships, and the overall quality of life. Dyads commonly report unmet needs for early support to address these challenges early after diagnosis.

OBJECTIVE

This study is part of a larger study that has the primary objective to develop, adapt, and establish the feasibility of Resilient Together for Dementia (RT-ADRD), a novel dyadic skills-based intervention aimed at preventing chronic emotional distress early after diagnosis. The present study protocol describes an open pilot of the RT-ADRD intervention. This study will allow the study team to gather feedback on intervention components, administration of study measures, issues within general protocol, and perceptions about live video interventions prior to a larger feasibility trial.

METHODS

All study procedures will be conducted on the web (via phone and health care system-supported videoconferencing) to optimize accessibility, inclusion, and representativeness. Eligible dyads will include couples (up to N=10) referred from Mount Sinai Hospital (MSH) clinics within 3 months of an ADRD diagnosis. Dyads will be referred by their diagnosing clinicians (eg, neurologists, geriatricians, and neuropsychologists) and screened for eligibility. Eligible dyads will have at least one member who exhibits clinically elevated emotional distress and will demonstrate capacity to consent to research participation on a standardized assessment. Consenting dyads will complete baseline assessments of emotional distress, quality of life, relationship functioning, and resiliency skills. Dyads will then participate in 6 weekly RT-ADRD sessions together (30-60 minutes each). After the conclusion of the intervention, dyad members will complete posttest assessments with similar measures as the pretest. Finally, dyads will participate together in a single 60-minute exit interview to gather information on intervention content and procedures to refine the intervention before a pilot feasibility trial.

RESULTS

This study has been approved by the MSH institutional review board and is registered on ClinicalTrials.gov (NCT06421545). We anticipate that the study will be completed by late 2024.

CONCLUSIONS

We will use these results to administer changes and develop procedures for a pilot feasibility trial of RT-ADRD relative to a minimally enhanced control condition. Our study will allow us to gather comprehensive information on proposed RT-ADRD procedures and content and the best ways of delivering prevention-focused interventions to reduce the potential for chronic emotional distress stemming from ADRDs.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60382.

摘要

背景

阿尔茨海默病及相关痴呆症(ADRDs)是日益常见的进行性疾病,对患者及其主要照护伙伴(二者统称为二元组)产生重大影响。ADRD诊断前后二元组成员所经历的压力源通常会导致临床上情绪困扰加剧(即抑郁和焦虑症状),这些症状可能会持续存在并对健康、人际关系和整体生活质量产生负面影响。二元组通常表示在诊断后早期未得到满足的早期支持需求,难以应对这些挑战。

目的

本研究是一项更大规模研究的一部分,该研究的主要目的是开发、调整并确定痴呆症共同复原力(RT - ADRD)的可行性,这是一种基于二元组技能的新型干预措施,旨在预防诊断后早期的慢性情绪困扰。本研究方案描述了RT - ADRD干预的开放性试点。本研究将使研究团队能够在更大规模的可行性试验之前,收集关于干预组成部分、研究措施的实施、总体方案中的问题以及对实时视频干预的看法的反馈。

方法

所有研究程序将通过网络(通过电话和医疗保健系统支持的视频会议)进行,以优化可及性、包容性和代表性。符合条件的二元组将包括在ADRD诊断后3个月内从西奈山医院(MSH)诊所转诊的夫妇(最多N = 10对)。二元组将由其诊断临床医生(如神经科医生、老年科医生和神经心理学家)转诊并进行资格筛选。符合条件的二元组将至少有一名成员表现出临床上情绪困扰加剧,并将在标准化评估中证明有能力同意参与研究。同意参与的二元组将完成情绪困扰、生活质量、关系功能和复原力技能的基线评估。然后,二元组将一起参加6次每周一次的RT - ADRD课程(每次30 - 60分钟)。干预结束后,二元组成员将使用与预测试类似的测量方法完成后测试评估。最后,二元组将一起参加一次60分钟的退出访谈,以收集有关干预内容和程序的信息,以便在试点可行性试验之前完善干预措施。

结果

本研究已获得MSH机构审查委员会的批准,并已在ClinicalTrials.gov上注册(NCT06421545)。我们预计该研究将于2024年底完成。

结论

我们将利用这些结果对RT - ADRD相对于最低限度强化对照条件的试点可行性试验进行修改并制定程序。我们的研究将使我们能够收集关于拟议的RT - ADRD程序和内容以及提供以预防为重点的干预措施以减少ADRDs导致的慢性情绪困扰可能性的最佳方法的全面信息。

国际注册报告识别码(IRRID):DERR1 - 10.2196/60382。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1710/11780288/2cb9d8a00bd4/resprot_v14i1e60382_fig1.jpg

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