iCardia4HF: A Multi-component mHealth App and Tailored Text-messaging Intervention to Promote Self-care Adherence and Improve Health Outcomes in Patients With Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Percentage of days lost due to unplanned cardiovascular hospitalizations or death from any cause
研究概览
简要总结
The goal of this factorial randomized trial is to examine the independent and synergistic efficacies of two mobile health technology interventions in people with chronic heart failure. The first intervention involves the use of multiple consumer mHealth apps and sensor devices (MyApps) for heart failure self-care (maintenance, monitoring, and management). The second intervention is a program of tailored text messages (Text4HF) targeting modifiable behavioral factors associated with heart failure self-care non-adherence. The main questions this study aims to answer are:
- Can the use of consumer mHealth apps and devices (MyApps) improve heart failure self-care and reduce days lost due to cardiovascular hospitalization or death for any cause?
- Can a program of individually tailored text messages (Text4HF) improve heart failure self-care and reduce the days lost due to cardiovascular hospitalization or death for any cause?
- Can MyApps and Text4HF combined lead to greater improvements in heart failure self-care and days lost due to cardiovascular hospitalization or death for any cause
详细描述
Heart failure (HF) remains one of the most frequent principal diagnoses for hospitalization and a leading cause of death in the United States. Up to 65% of HF readmissions are the result of insufficient self-care. Existing HF self-care interventions delivered face-to-face or via telephone have had limited impact and reach. They require significant provider time and are not always accessible to patients. There is an urgent need for accessible and scalable interventions that are designed to assist patients with HF self-care while in the community to reduce HF readmissions. Consumer mobile health (mHealth) technologies (e.g., mobile apps and sensor devices) hold promise for promoting HF self-care and expanding intervention delivery. However, their efficacy remains largely underexplored.
To address this gap, our team developed a patient-centered HF self-care intervention (iCardia4HF) that combines the use of three consumer mobile health apps and connected health devices (MyApps) with a program of individually tailored text messages (Text4HF) targeting modifiable behavioral factors to promote HF self-care adherence and improve clinical outcomes.
This study aims to conduct a fully powered, 2x2 factorial randomized controlled trial to determine the independent and combined efficacy of the two iCardia4HF intervention components (MyApps and Text4HF) at 6 months, as well as their maintenance efficacy at 6 months post-intervention. A total of 360 patients with HF will be recruited and randomized to one of four conditions for 12 months: (1) Usual care, (2) Text4HF, (3) MyApps, or (4) MyApps&Text4HF. Specific aims are:
Aim 1: Determine the independent and combined efficacies of MyApps and Text4HF at 6-months on the primary outcome of days lost due to cardiovascular hospitalization or death for any cause, and secondary outcomes of HF self-care and health status.
Hypothesis 1a: MyApps and Text4HF will have significant main effects on the primary outcome at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Care providers who provide usual care to study participants will be unaware of the study groups and group assignments. Outcome assessors will be masked to group assignment. Outcome assessors will work in a different office from other study investigators and will have limited access to the Electronic Data Capturing system used for data collection (REDCap).
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 Stage C Heart Failure
- •≥ 18 years of age
- •Transthoracic Echocardiogram or Cardiac MRI performed in the last 3 years and LVEF results available
- •Patient is actively treated with oral loop diuretics for chronic heart failure
- •Hospitalization due to acute decompensated heart failure within 24 months before randomization and/or insufficient self-care per SCHFI assessment (score of ≤3, in at least two items of the SCHFI v7.2 maintenance, symptom monitoring, or self-care management subscale)
- •Ability to speak and read English
排除标准
- •Implanted ventricular assist device
- •High urgent listed for heart transplantation
- •Acute coronary syndrome within the last 7 days before randomization
- •Revascularization and/or CRT implantation within 28 days before randomization
- •Planned revascularization, transcatheter aortic valve implantation, MitraClip and/or CRT implantation within 3 months after randomization
- •End-stage HF (hospice candidate)
- •Discharge to a setting other than home
- •Individuals who have a home nurse or are not able to take care of self (eat, dress, walk, bathe, take medications, or use the toilet)
- •Chronic renal insufficiency with hemodialysis or estimated Glomerular Filtration Rate <25 mL
- •Active cancer, currently undergoing treatment (e.g. radiation immunotherapy)
- •Existence of any disease reducing life expectancy to less than 1 year
- •Cognitive impairment (e.g., Dementia, Parkinson disease, Alzheimer disease, MoCA<18, impaired self-determination, lacking ability to communicate)
- •Major physical impairment (e.g., inability to walk, bound on a wheelchair)
- •Unwillingness to use study equipment
- •Active substance abuse
- •Currently pregnant, less than 3-month post-partum or pregnancy anticipated during the study
- •Participation in other treatment studies or remote patient management programs
- •Participation in the iCardia4H pilot trial (conducted before this study)
研究组 & 干预措施
Enhanced usual care
Participants assigned to the usual care group will receive (1) standard care, (2) patient education about HF self-care, and (3) three connected health devices. Usual care includes follow-up appointments every 2-3 months with a multidisciplinary team at the outpatient HF clinic. Patient education includes resources about HF self-care from the American Heart Association and Heart Failure Society of America. Connected health devices include the Withings Weight Scale, Withings blood pressure monitor, and Fitbit Charge 6 activity tracker (wrist-based with heart rate sensor). Participants will receive the devices at baseline along with training by research staff on how to use the devices to perform daily self-monitoring of weight, blood pressure, and physical activity/inactivity. The Withings devices have a cellular antenna for automatic transmission of data to our study server (iCardia). Fitbit will be paired with the participant's smartphone.
干预措施: Enhanced Usual Care (Behavioral)
Text4HF
Participants allocated to the Text4HF group will receive the same components and devices as the usual care group (usual care, patient education, and connected health devices), plus individually tailored Text Messages targeting health beliefs, HF-knowledge, and self-efficacy about HF self-care. Participants will receive 4-6 TMs/week during the induction phase (0 to 3 months), and 2-4 TMs per week during the adoption period (3 to 6 months).Tailoring of the TMs is guided by participants' responses to validated instruments assessing intervention target variables at baseline and 3 months
干预措施: Text4HF (Behavioral)
MyApps
In addition to usual care and patient education resources, participants in the MyApps group will receive three commercially available apps (Heart Failure Storylines, Withings Health Mate, and Fitbit), and three connected health devices (Withings Body Cardio Scale, Withings BP monitor, and Fitbit activity tracker). The apps interface with the devices via Bluetooth offering patients a comprehensive set of mHealth tools that support the core elements of HF self-care (maintenance, self-monitoring, and self-management).
干预措施: MyApps (Behavioral)
MyApps + Text4HF
Participants in this group will receive the MyApps and Text4HF intervention components, combined.
干预措施: MyApps & Text4HF (Behavioral)
结局指标
主要结局
Percentage of days lost due to unplanned cardiovascular hospitalizations or death from any cause
时间窗: 6 months
Hospitalization is defined as hospital admission resulting in an overnight stay where the length of stay is at least 24 hours. Events leading to emergency department visit only with a length of stay under 24 hours will not be classified as hospitalization. For a hospitalization to be considered as unplanned the patient must present new symptoms and/or worsening of existing symptoms with the need for immediate admission in a hospital for intensified care. A hospitalization will be considered "cardiovascular" when it is due to cardiovascular causes which includes but is not limited to: HF deterioration, acute myocardial infarction, arrhythmia, HF, pulmonary embolism, cerebrovascular disease (e.g., stroke), severe bleeding, endocarditis, etc.
次要结局
- Percentage of days lost due to unplanned cardiovascular hospitalizations or death from any cause(12 months)
- Number of patients with unplanned cardiovascular hospitalizations(6 and 12 months)
- Mean number of unplanned cardiovascular hospitalizations(6 and 12 months)
- Unplanned heart failure hospitalizations(6 and 12 months)
- Mean number of unplanned heart failure hospitalizations(6 and 12 months)
- Emergency Room visits(6 and 12 months)
- All-cause mortality(6 and 12 months)
- Medication adherence - Dose count(6 and 12 months)
- Medication adherence - Dose days(6 and 12 months)
- Weighing adherence(6 and 12 months)
- Blood pressure monitoring adherence(6 and 12 months)
- Steps(6 and 12 months)
- Moderate-to-vigorous physical activity (MVPA) minutes(6 and 12 months)
- Self-care maintenance(3, 6, 9, and 12 months)
- Symptom perception(3, 6, 9, and 12 months)
- Self-care management(3, 6, 9, and 12 months)
- Self-care efficacy(3, 6, 9, and 12 months)
- Health Status(3, 6, 9, and 12 months)
- Heart Failure Knowledge(3, 6, 9, and 12 months)
研究者
Spyros Kitsiou
Associate Professor
University of Illinois at Chicago