TRAjectories and CLinical ExpeRiences of ICD Therapy Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Semi-competing risks model of deaths and/or ICD shocks
研究概览
简要总结
This is a prospective cohort study of older patients receiving implantable cardioverter-defibrillators. The purpose of the TRACER-ICD study is to conduct a prospective cohort investigation with the goal of 500 patients age >65 receiving new primary prevention implantable cardioverter-defibrillators (ICDs). Patients will be followed quarterly for 18 months with interviews, electronic record review, and remote monitoring to characterize clinical and functional trajectories following device implantation, with permission for extended electronic follow-up for up to 10 years (Aim 1). This cohort will support validation and refinement of an established model for predicting personalized outcome profiles for ICD therapies and death (Aim 2). Lastly, we will combine electronic record review with semi-structured interviews with patients and physicians to evaluate physician and patient experiences with a prototype individualized shared decision-making (SDM) tool (Aim 3).
详细描述
Study Objectives and Design
The specific aims, applicable methods, and main hypotheses of the TRACER-ICD study are as follows:
Aim 1: To characterize the clinical course of patients aged >65 after ICD implantation by establishing a multicenter prospective cohort (N=500). Baseline (verbal and in-person) and quarterly (phone, electronic health records [EHR], remote monitoring) data collected up to 18 months or death will include: a. geriatric assessments (e.g. frailty, cognition,1 functional status; b. comorbidities; c. quality of life and symptom burden; d. health services use; e. SDM history; and f. ICD-recorded physical activity (minutes/day).
Factors associated with death and poor quality of life will be identified. Group-based trajectory modeling will identify patient clusters with distinct trajectories of functional status and quality of life following ICD implantation.
H1: A model integrating frailty and clinical factors will predict (a) death, (b) poor quality of life, and (c) unfavorable functional trajectories after ICD implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for ICD implantation will be identified at participating sites by site staff. Eligibility criteria will include the following, all of which must be met by all participants for participation:
- •Patient receiving new primary prevention ICD (single, dual chamber, or subcutaneous system)
- •Age >65 years
- •English-speaking (assessment instruments are only available/validated in English)
- •Sufficient cognitive ability to provide consent (i.e. answer simple questions on study participation, purpose and procedures)
- •Candidates meeting the following
排除标准
- •at baseline will be excluded from study participation:
- •Receipt of cardiac resynchronization therapy device
- •Participation in another investigational drug or intervention trial expected to influence any of the outcomes of interest in this study
- •Current drug or alcohol use or dependence that, in the opinion of the Site Principle Investigator, would interfere with adherence to study requirements.
结局指标
主要结局
Semi-competing risks model of deaths and/or ICD shocks
时间窗: Up to 18 months
Personalized outcome profiles for death +/- ICD shocks
Outcomes after ICD Implantation
时间窗: Up to 18 months
Death/Poor Quality of Life (combined endpoint)
Clinical Trajectories after ICD implantation
时间窗: Patients will be followed quarterly for 18 months or to death.
Group-based trajectory modeling will identify patient clusters with distinct trajectories of functional status and quality of life following ICD implantation.
次要结局
未报告次要终点
研究者
Daniel B. Kramer
Assistant Professor of Medicine
Beth Israel Deaconess Medical Center