iCardia4HF: A Patient-centered Mobile Health Intervention to Promote Self-care and Improve Patient Outcomes in Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change from Baseline in Self-care at 30 and 60 days
研究概览
简要总结
Approximately 6.5 million people have heart failure (HF) in the United States, and 960,000 new cases are reported each year. HF is one of the most common hospital diagnosis among older adults. About 40% of patients are readmitted within 1-year following their first admission for HF and hospitalization accounts for approximately 80% of the costs of HF management. This pilot study aims to assess the feasibility, acceptability, and preliminary efficacy of a patient-centered mobile health (mHealth) technology intervention in older adults with chronic heart failure.
详细描述
This is a single site, two-arm, pilot randomized controlled trial that aims to examine the feasibility, acceptability and preliminary efficacy of a mobile phone-based intervention compared to usual care in older adult patients with HF (≥50 years). Forty (n=40) patients from the University of Illinois Hospital & Health Sciences system will be enrolled in the study, randomly assigned to the intervention or usual care group, and followed for 60 days. Patients in the intervention group will receive the Heart Failure Health Storylines mobile app developed by Self Care Catalysts in collaboration with the Heart Failure Society of America, three connected health devices from Fitbit and Nokia that interface with the mobile app, and tailored text-messages targeting health beliefs, self-care efficacy, and knowledge about HF. The control group will receive standard care which involves patient education and outpatient follow up with physical and laboratory examinations as needed. The primary study outcome is change in self-care and quality of life. Secondary outcomes include hospital re-admissions and emergency room visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to patients' randomization assignment
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients or outpatients with a diagnosis of HF as defined by the International Classification of Diseases (ICD-10) codes
- •Stage C, NYHA I, II or III
- •≥ 40 years of age
- •Own a smartphone with text-messaging and internet plan
- •Ability to speak and read English
- •Live within 30 miles from UI Health
排除标准
- •On an active waiting list for implanted ventricular assist device or heart transplant
- •Advanced renal disease (dialysis or creatinine >4.0mg/dL)
- •End-stage HF (hospice candidate)
- •Active cancer
- •Individuals who are not their own primary caregiver
- •Discharge to a setting other than home
- •Patients with baseline Montreal Cognitive Assessment (MoCA) score of < 22
结局指标
主要结局
Change from Baseline in Self-care at 30 and 60 days
时间窗: Baseline, 30 and 60 days
Self-care will be measured with the Self-Care Heart Failure Index (SCHFI) v.6.2,87 which includes 3 subscales: self-care maintenance (10-items), self-care confidence (6-items), and self-care management (6-items). Standardized scores in each scale range from 0 to 100. A total score of ≥70 indicates adequate self-care.
Change from Baseline in Health-related Quality of Life (HRQoL) at 30 and 60 days
时间窗: Baseline, 30 and 60 days
HRQoL will be measured with the Kansas City Cardiomyopathy Questionnaire (23-items) that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Lower scores indicate worse HRQoL.
次要结局
- Hospitalizations(60 days)
- ER visits(60 days)
研究者
Spyros Kitsiou
Assistant Professor
University of Illinois at Chicago