Study for Deployment of American Heart Association Heart Failure Protocols and Educational Content Within the Intel® Health Guide System With a Congestive Heart Failure Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Percentage of Days Participants Measured Vitals and Completed Protocol Sessions
研究概览
简要总结
This purposed of this study is to ascertain if the implementation of remote patient management systems utilizing American Heart Association (AHA) guideline-based heart failure protocols and educational content can improve the management of patients with congestive heart failure.
详细描述
This prospective, comparative study uses a pre-post test design to ascertain if the implementation of remote patient management systems utilizing AHA guideline-based heart failure protocols and educational content can successfully address the following objectives:
- validate the suitability of the Intel Health Guide to deploy AHA guideline-based patient care protocols and health content to patients managing congestive heart failure
- confirm that the AHA protocols as deployed on the HGS are supportive for clinicians following the AHA guidelines in a telehealth environment
- validate and verify that the data intended to be collected was effectively collected
- measure patient and provider satisfaction with use of the system
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a diagnosis of Heart Failure NYHA and is currently in functional class II- IV status.
- •Patient has been hospitalized for an episode of acute HF decompensation within the last 30 days.
- •Patients with other co-morbidities such as atrial fibrillation, diabetes, coronary artery disease, COPD, hypertension, may be included in this evaluation. These conditions shall be documented during enrollment.
- •Have telephone line or broadband internet availability to connect Intel® Health Guide.
- •Are physically and mentally capable to complete the monitoring process or have a caregiver capable of assisting in the use of the Intel® Health Guide.
- •Will be willing and able to sign an informed consent form to participate in this evaluation for a duration of 60 days.
- •Live within a reasonable distance (30 miles or less) from the institution.
排除标准
- •Have a life expectancy of less than six months.
- •Live in a nursing home or other multi-member assisted living facility.
- •Intend to be away from their home for more than 2 weeks (14 days) total during the 60 days.
- •Are unable to read English at a minimum 5th grade level.
- •Do not live within a reasonable distance (30 miles or less) from the institution.
结局指标
主要结局
Percentage of Days Participants Measured Vitals and Completed Protocol Sessions
时间窗: 60 days
Measuring the percentage of available days the patient measures and records his/her vitals (weight, blood pressure, blood oxygen saturation level, glucose level) and completes his/her protocol sessions during the monitoring period. Utility was defined as days of activity and interaction of the patient with the monitor / days of actual monitoring possible.
Percentage of Health Sessions That Patients Measured and Recorded Vitals
时间窗: 60 days
Measuring the percentage of available health sessions that the patient measures and records his/her vitals (weight, blood pressure, blood oxygen saturation level, glucose level) and during the monitoring period. Adherence (or patient compliance) was defined as the percent of actual completed sessions from the number of scheduled sessions offered.
次要结局
- Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Clinical Summary Score Change(Baseline is taken at the beginning of the study, 2nd is at 30 days and 3rd is at 60 days.)
- Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Overall Score Change(Baseline is at the beginning of study, 2nd is at 30 days and 3rd is at 60 days.)
研究者
Ileana L. Piña
Professor of Medicine & Epidemiology and Population Health, Albert Einstein College of Medicine, Montefiore Medical Center
American Heart Association