Pilot Study of Acceptability and Feasibility of StudyU for N-of-1 Trials
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Feasibility of Intervention Measure Score
研究概览
简要总结
This study will look at whether using a phone app called StudyU can help people with Heart Failure with Reduced Ejection Fraction (HFrEF) reach their recommended dose on their beta blocker.
详细描述
The overarching goal of this study is to determine feasibility of the StudyU app in N-of-1 trials. The study intervention is N-of-1 trials, facilitated by a mobile-based application, StudyU. The study team will utilize a single-arm sequential design N-of-1 study in which subjects who are not yet at the GDMT for beta blockers will test multiple doses of GDMT to understand the maximally tolerated dose using an N-of-1 trial format. This is similar to an approach used in a previous study, Pilot Deprescribing N-of-1 Trials for beta blockers in HFpEF (NCT04757584) but will test the addition of a mobile-based app to collect vital signs, monitor side effects, and monitor patient-reported outcomes.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 65 years old
- •A history of HFrEF per electronic medical record review/clinician impression that is defined as an EF <50% that is shown from any imaging modality
- •Taking less than the maximal dose of beta blocker per physician recommendation at time of enrollment
- •Access to a smartphone or device that can perform many of the same functions as a computer, typically having a touchscreen interface, internet access, and an operating system capable of running downloaded applications
排除标准
- •Clinical instability (this N-of-trial is appropriate for stable conditions only)
- •Decompensated HF
- •Hospitalized in the past 30 days
- •Medication changes or procedures in prior 14 days (to prevent confounding from other interventions) at PI discretion
- •Do not have access to a smartphone or tablet
- •Estimated life expectancy <6 months
- •Moderate-severe dementia or psychiatric disorder precluding informed consent
- •Language barrier that will preclude informed consent and ability to comprehend study procedures
- •History of noncompliance or inability to complete study procedures
- •Enrollment in a clinical trial not approved for co-enrollment
- •Any condition that, in Principal Investigator or treating physician's opinion, makes the patient unsuitable for study participation
研究组 & 干预措施
GDMT (Beta Blockers)
This study consists of a single arm. Subjects will complete study activities remotely. Following enrollment, daily assessments will be conducted using the StudyU mobile application. Additional assessments will occur at the end of each study period, completed by phone, WCM Zoom, or via email, depending on subject preference. The study involves testing multiple doses of each subject's guideline-directed medical therapy (GDMT), specifically beta-blockers. Doses will include the subject's current home dose (as prescribed by their treating physician prior to enrollment), as well as one or more increased -and, if needed, decreased-doses that are near or at the guideline-directed maximum. All dosing decisions will be made collaboratively by the PI, the subject's clinician, and the participant, taking into account titration guidelines, physician guidance, and subject symptoms and preferences. Each subject will complete a minimum of two periods. The number of periods is adaptive.
干预措施: beta blockers (Drug)
GDMT (Beta Blockers)
This study consists of a single arm. Subjects will complete study activities remotely. Following enrollment, daily assessments will be conducted using the StudyU mobile application. Additional assessments will occur at the end of each study period, completed by phone, WCM Zoom, or via email, depending on subject preference. The study involves testing multiple doses of each subject's guideline-directed medical therapy (GDMT), specifically beta-blockers. Doses will include the subject's current home dose (as prescribed by their treating physician prior to enrollment), as well as one or more increased -and, if needed, decreased-doses that are near or at the guideline-directed maximum. All dosing decisions will be made collaboratively by the PI, the subject's clinician, and the participant, taking into account titration guidelines, physician guidance, and subject symptoms and preferences. Each subject will complete a minimum of two periods. The number of periods is adaptive.
干预措施: StudyU Application (Device)
结局指标
主要结局
Feasibility of Intervention Measure Score
时间窗: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
The Feasibility of Intervention (FIM) measure is a survey that evaluates an intervention's practicality. Questions are ranked on 1- to 5-point Likert scales, with higher scores indicating higher feasibility and lower indicating less feasibility. Total scores range from 4 to 20. A score of 4 indicates low feasibility and a score of 20 indicates strong feasibility.
Intervention Appropriateness Measure Score
时间窗: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
The Intervention Appropriateness Measure (IAM) is a survey that evaluates an intervention's suitability and compatibility. Questions are ranked on 1- to 5-point Likert scales, with higher scores indicating higher appropriateness and lower indicating less appropriateness. Total scores range from 4 to 20. A score of 4 indicates low appropriateness and a score of 20 indicates strong appropriateness.
Acceptability of Intervention Measure Score
时间窗: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
Acceptability of Intervention Measure (AIM) is a survey that evaluates how agreeable an intervention is to participants. Questions are ranked on 1- to 5-point Likert scales, with higher scores indicating higher acceptability and lower indicating less acceptability. Total scores range from 4 to 20. A score of 4 indicates low acceptability and a score of 20 indicates strong acceptability.
次要结局
- Change in KCCQ-12 Score(Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).)
- Change in PROMIS-29 Score(Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).)
- Change in PROMIS CF-SF 6a Score(Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).)
- Change in PROMIS Sexual Function Score(Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).)