Initial Assessment of the Usability of Remote Monitoring of Respiration Parameters in the Routine Management of Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- ResMed
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Percent Successful Data Transmissions
研究概览
简要总结
This study is designed to descriptively assess improvement in quality of life and test the usability of remotely monitored respiration parameters in the routine management of recently discharged heart failure patients. It will consist of two arms: (i) intervention, and (ii) control. Participants will be randomized to either arm at time of enrollment. Every participant enrolled in the study will receive a device for remote monitoring.
详细描述
Heart failure ('HF') presents an increasing social and economic burden, especially with respect to HF related hospitalizations. Some commentators suggest that these costs may double within the next two decades. Respiration patterns are well acknowledged as having diagnostic and prognostic value in HF. In this preliminary study, the investigators assess the usability of remote monitoring of respiration parameters in the routine management of HF patients.
Objectives: (primary and important secondary objectives)
The primary aims are:
- Assess usability of the system (primary measurement is % of successful data transmissions from participants' homes, secondary measurement includes scores from the System Usability Scale)
- Assess quality of life (as measured using the KCCQ) for HF patients monitored with a non-contact respiration monitor which can be used by clinicians to guide standard therapy.
Other key secondary objectives include examining trends in healthcare utilization, descriptively assessing any differences in care patterns post hoc between participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age ≥18 years old
- •Patients admitted to hospital for worsening of heart failure; Worsening of heart failure is defined as symptoms consistent with worsening of heart failure, including dyspnea and an elevated BNP. Patients must have existing diagnosis of heart failure, either preserved ejection fraction or reduced ejection fraction (HFpEF or HFrEF)
- •Weight ≥35 kg
- •Pre-Menopausal Women ≥18 years of age must have a negative urine/serum pregnancy test or pre-menopausal women with evidence of surgical sterilization or post-menopausal women.
- •Must qualify for standard home care post discharge
- •Must be able to read and understand English and consent for themselves
排除标准
- •Under 18 years of age
- •Participant is on a form of non-invasive positive airway pressure ventilation (in such cases, respiratory rates and variability will reflect combined physiology plus machine effect)
- •Participant has an existing diagnosis in the medical record for sleep disordered breathing, whether on therapy or not
- •Participant has cognitive impairment (determined by physician) that will make it hard for them to follow instructions regarding therapy usage
- •Patients who are discharged to hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities
- •Patients who are actively being monitored using a pulmonary arterial pressure monitor (CardioMEMs)
- •Patients with COPD GOLD Stage III or IV
- •Planned procedures at time of discharge that will occur within timeframe of study that will require hospitalization etc.
- •Participant declines to participate at any time.
- •Patients involved in therapy intervention clinical trials
- •Any investigational drug use within 30 days prior to enrollment.
- •Pregnant or lactating females.
- •Participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
- •Participants who have no cellular coverage at their primary residence
结局指标
主要结局
Percent Successful Data Transmissions
时间窗: One year
Number of successful data transmissions compared to number of possible data transmissions
Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire
时间窗: One year
Quality of life as measured by Kansas City Cardiomyopathy Questionnaire
次要结局
- HF Drug Changes(One year)
- HF Drug Compliance(One year)
- Respiration Patterns(One year)
- System Usability(One year)
- Sleeping Patterns(One year)
- Healthcare Utilization(One year)
- Biomarkers(One year)