A Multifaceted Adaptive Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 20
- 主要终点
- Hierarchical Combination ("Win Ratio") of Time to All-cause Mortality, Time to Heart Failure Hospital Readmission, and Decline in Health-related Quality of Life (HRQOL) [ Time Frame: Baseline up to Week 12 ]
研究概览
简要总结
This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients.
详细描述
The Manage HF study is a multicenter 12-week randomized controlled double-blind 2x2 factorial clinical trial. This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients. The clinical worsening intervention targets self-management of behaviors to prevent worsening of a patient's heart failure symptoms. The dietary sodium intervention promotes lower sodium intake. Eligible participants will be randomized to the dietary sodium intervention, the clinical worsening intervention, both interventions, or no intervention in a 1:1:1:1 manner, stratified by site, gender, and HF type (HFpEF versus HFrEF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 18 years and older at screening
- •Currently admitted or discharged from the hospital within the last 14 days with a diagnosis of acute or acute on chronic decompensated HF.
- •Based on one of the EF criteria (LVEF within 12 months of randomization. BNP or NT-proBNP criteria within 30 days prior to randomization):
- •Left ventricular ejection fraction (LVEF) ≤ 40%.
- •LVEF >40% and BNP > 175 pg/ml or NT-proBNP > 700 pg/ml. Thresholds for NT-proBNP and BNP for LVEF > 40% will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m
- •Have a personal physician for follow-up
- •A smartphone with a compatible Apple or Android operating system installed and able to download and use ManageHF including accepting all permissions
- •A valid email address
- •Fluent in spoken and written English
排除标准
- •Contraindication to recommending a sodium restriction diet
- •Scheduled intervention for primary valvular heart disease will occur during the study period.
- •Cardiac resynchronization therapy (CRT) within 3 months prior to screening or current plan to implant CRT device during the study period.
- •Previous cardiac transplantation or implantation of a ventricular assistance device or similar device.
- •Listed status 1, 2 or 3 for heart transplant
- •Implantation of a ventricular assistance device is expected within 3 months after randomization
- •Non-cardiac illness with expected survival of less than 3 months
- •Discharge to a setting other than home
- •Requirement for chronic inotropic therapy (e.g. milrinone, dobutamine)
- •Inability to use Withings devices due to equipment limitations or contraindications
- •Currently pregnant or intend to become pregnant during the study period.
研究组 & 干预措施
Dietary Sodium Intervention 'B'
The dietary sodium intervention facilitates lower sodium choices using tailored push notifications.
干预措施: Sodium intervention (Behavioral)
Dietary Sodium and Clinical Worsening 'D'
Full access to all content in the control, dietary sodium, and clinical worsening interventions.
干预措施: Sodium intervention (Behavioral)
Dietary Sodium and Clinical Worsening 'D'
Full access to all content in the control, dietary sodium, and clinical worsening interventions.
干预措施: Clinical worsening intervention (Behavioral)
Control Group 'A'
Standard heart failure educational information.
干预措施: Educational content (Behavioral)
Clinical Worsening Intervention 'C'
The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications.
干预措施: Clinical worsening intervention (Behavioral)
结局指标
主要结局
Hierarchical Combination ("Win Ratio") of Time to All-cause Mortality, Time to Heart Failure Hospital Readmission, and Decline in Health-related Quality of Life (HRQOL) [ Time Frame: Baseline up to Week 12 ]
时间窗: 12 weeks
Time to all-cause mortality (ACM), time to heart failure hospital readmission (HFHR), and decline in quality of life will be analyzed using the Finkelstein-Schoenfeld method. The method combines these three endpoints in a hierarchical fashion using ACM first, HRHR second, and change in HRQOL third. The method pairs every participant receiving the diet intervention with every participant not receiving the diet intervention within each stratum. Within each pairing, a +1 is assigned to the "better" participant, -1 to the "worse" participant, and 0 if they are "tied". The comparison begins with ACM. Tied pairings are then compared using HFHR. Any remaining tied pairings are compared using change in HRQOL. A 'Win' represents a participant doing better within each pairing (receiving +1) based on the hierarchical comparison. The reported unit is the total "wins" for each intervention group from performing such a hierarchical comparison across all strata.
次要结局
- Heart Failure-related Hospitalizations [ Time Frame: Baseline up to Week 12 ](12 weeks)
- All-Cause Mortality [ Time Frame: Baseline up to Week 12 ](12 weeks)
- Change From Baseline in Health-related Quality of Life [ Time Frame: Baseline up to Week 12 ](12 weeks)
研究者
Michael Dorsch
Associate Professor of Clinical Pharmacy
University of Michigan