EVOLVE: a Virtual, Observational, Patient-Centric Prospective Study to Evaluate Real-World Use of Next Generation Infusion Pumps to Administer Remodulin to Patients with Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- To observe and assess patient reported outcomes via the emPHasis-10 questionnaire
研究概览
简要总结
To observe and assess drug administration activities, time spent on drug administration activities, and patient-reported outcomes (PROs) including quality of life, treatment satisfaction, and patient perception of devices related to use of United Therapeutics Corporation (UTC)-developed next-generation infusion pumps to administer Remodulin in patients with Pulmonary Arterial Hypertension (PAH).
详细描述
This is a virtual, patient-centric, observational study that will follow approximately 60 participants through 8 weeks following initiation of Remodulin therapy via their UTC-developed next generation infusion pump and consists of remote and electronic assessments administered to patient via the uMotif® data capture platform at Study Enrollment, Week 2, Week 4, and Week 8 or Early Withdrawal (if applicable).
The study population will consist of 2 cohorts of PAH patients:
- De Novo Cohort: patients new to parenteral prostacyclin-class therapy.
- Transition Cohort: patients who had been receiving SC treprostinil therapy via a previous generation infusion pump prior to transitioning to a next generation infusion pump.
The De Novo Cohort will initiate subcutaneous (SC) Remodulin via a next generation infusion pump as prescribed by their healthcare professional. Participants will be followed from day of Study Enrollment, which will be Day 1, through 8 weeks while using next generation infusion pump, or until discontinuation of Remodulin (early withdrawal), whichever comes first.
The Transition Cohort will have previously been receiving SC treprostinil utilizing a previous generation infusion pump prior to transitioning to delivery of Remodulin via next generation infusion pump, as prescribed by their healthcare provider. Participants will be followed from day of Study Enrollment, which will be Day 1, through 8 weeks while using next generation infusion pump, or until discontinuation of Remodulin (early withdrawal), whichever comes first.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •The patient is pregnant, trying to become pregnant, or lactating.
- •For those in the Transition Cohort: The patient has a history of adverse events resulting from interruptions in their treprostinil infusions over relatively short periods (such as less than 8 hours) as they may be at higher risk in the event of pump failure, especially at night.
- •The patient is enrolled in, has participated within the last 30 days, or is planning to participate in an interventional study. Note: co-enrollment in other observational studies is permitted.
- •For those in the Transition Cohort: The patient had been receiving parenteral treprostinil via IV administration prior to transitioning to the Remunity Pump.
结局指标
主要结局
To observe and assess patient reported outcomes via the emPHasis-10 questionnaire
时间窗: 8 Weeks
The emPHasis-10 questionnaire is a reliable and validated tool for assessment of health-related quality of life in pulmonary hypertension. It consists of 10 items, which address breathlessness, fatigue, control, and confidence.
To observe and assess patient reported outcomes via the Pulmonary Hypertension Functional Class Self-Report
时间窗: 8 Weeks
Participant self-assessment of Functional Class (I to IV) will be performed using the Pulmonary Hypertension Functional Class Self-Report (PH-FC-SR), as adapted from the pulmonary hypertension World Health Organization Functional Classification System.
To observe and assess time spent on drug administration activities related to the United Therapeutics Corp.-developed next generation pumps to administer Remodulin in patients with PAH
时间窗: 8 Weeks
Participants will be asked to participate in a comprehensive collection of the drug administration activities data consisting of a 7-day evaluation period of daily drug administration activities pertaining to their next generation infusion pump via the Drug Administration Activities Diary.
To observe and assess patient reported outcomes via the Patient Perception of Parenteral Infusion System Questionnaire
时间窗: 8 Weeks
The Patient Perception of Parenteral Infusion System Questionnaire will be administered to assess the participant's perception of their infusion pumps.
To observe and assess patient reported outcomes via the Abbreviated Treatment Satisfaction Questionnaire for Medication
时间窗: 8 Weeks
The Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a validated instrument to assess participants' satisfaction with medication, providing scores on 3 scales - effectiveness, convenience, and global satisfaction.
次要结局
未报告次要终点