Design of a Mobile Technology-Based System for Patient Engagement and Physician-Directed Remote Management of Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Patients' Engagement score
研究概览
简要总结
This pilot study is to assess the feasibility, preliminary utility and acceptance of a digital technology-based system for heart failure management.
详细描述
Heart failure continues to be a major public health problem. High-value, guideline-directed medical therapies (GDMT) for heart failure can reduce mortality and improve quality of life. However, large gaps in treatment with GDMT persist. While prior quality improvement efforts have focused on heart failure hospitalizations, there is a critical need to improve the quality-of-care post-discharge when the initiation and up-titration of GDMT is critical to optimizing outcomes. The main purpose of this pilot study is to assess the feasibility, preliminary utility and acceptance of a digital technology-based system for heart failure management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Diagnosis of heart failure
- •Most recent left ventricular ejection fraction ≤ 40% in the prior year based on echocardiogram, MRI, CT, or nuclear perfusion
- •Primary cardiologist enrolled in the study
- •Currently admitted with upcoming discharge or discharged from hospital within the prior 2 weeks
- •At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA, or SGLT2i) not yet initiated or on ≤ 50% of target dose
排除标准
- •Receives dialysis
- •Inotropic therapy during hospitalization
- •History of heart transplant or actively listed on heart transplant waiting list
- •History of left ventricular assist device implantation
- •Cardiac amyloidosis
- •Pregnant or currently trying to be pregnant
- •Life expectancy estimated less than 6 months related to non-cardiac comorbidities as per investigator's judgement
- •Actively enrolled in hospice or comfort care
- •Currently participating in an investigational device or drug study or having participated in such a study within 30 days prior to screening
- •Subject or their caregiver without a smartphone
- •Subject or their caregiver not proficient with written and spoken English
- •Subject unavailable to complete all study procedures (e.g., interviews) to the best of the subject and investigator's knowledge
- •Any other disorder or condition that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- •Subject has diminished decision-making capacity
- •Planned discharge to skilled nursing facility
结局指标
主要结局
Patients' Engagement score
时间窗: At Study completion (12-week follow-up visit)
A weighted proportion of requested actions completed by the patient. These actions include daily blood pressure measurements, daily weight assessment, daily health status assessment, biweekly KCCQ-12 assessment, and review of educational videos and health summary data. The minimum score is 0% and maximum score is 100%.
Clinicians' Response to Notification
时间窗: At Study completion (12-week follow-up visit)
The proportion of DOT-HF clinician notifications that lead to a clinician response over the 12-week follow-up period. Each of the clinician DOT-HF notifications are detailed below. These include notification of eligible therapy adjustment, worsening patient-reported health status, and weight gain. Eligible clinician actions include medication changes or new telephone, video, or in-person clinic encounters in response to the notification.
Patient Acceptability of the intervention
时间窗: At Study completion (12-week follow-up visit)
The proportion of patients who assess the DOT-HF intervention as an acceptable method of post-discharge heart failure management. This will be assessed during a semi-structured interview between individual participants and a trained interviewer.
次要结局
- Proportion of days with blood pressure (systolic) assessed(At Study Completion (12-week follow-up visit))
- Guideline-Directed Medical Therapy Score(Baseline, At study completion (12 week follow-up visit))
- Proportion of days with weight assessed(At Study Completion (12-week follow-up visit))
- Proportion of Kansas City Cardiomyopathy Questionnaire-12 assessments completed(At Study Completion (12-week follow-up visit))
- Sustainability of DOT-HF technology for Patients(At 6 week, At Study Completion (12-week follow-up visit))
- Feasibility of DOT-HF technology for Patients(At Study Completion (12 week follow up visit))
- Acceptability of DOT-HF technology for Clinicians(At study completion (12 week follow up visit))
- Generalizability of the DOT-HF Intervention(At study completion (12 week follow up visit))
- Proportion of days with daily health status completed(At Study Completion (12-week follow-up visit))
- Utility of DOT-HF technology for Clinicians(At study completion (12 week follow up visit))
- Proportion of days with medication adherence assessed(At Study Completion (12-week follow-up visit))
研究者
Alexander Sandhu
Instructor, CVMed, Department of Medicine
Stanford University