(e-MOTION PH) Electronic - Activity Level Monitoring Pilot in Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 35
- 主要终点
- 6-minute walk distance (6MWD)
研究概览
简要总结
Evaluate the correlation between activity level (monitored by Fitbit Flex remote activity tracker) and 6-minute walk distance (6MWD) (performed by investigator) in patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) over 6 months in routine clinical practice settings.
详细描述
Remote patient monitoring can lead to improved patient outcomes, including improved quality of life, reduced readmissions, earlier treatment for symptoms detected prior to schedule in-office follow-up visits, improved communications with care providers, increased participation in self-management of disease, and an improved knowledge of their medical conditions . In patients with PAH, daily activity level, as measured using a physical activity monitor for seven consecutive days, correlated with 6-minute walk distance (6MWD). The monitor used in the aforementioned PAH study was positioned on the patients' right upper arm with an armband, as opposed to the more popular and more comfortable wristbands used today, such as the Fitbit Flex. Although the aforementioned PAH study did show a correlation between activity level monitoring and 6MWD, the patients were monitored for only seven days. It is still unknown whether this correlation would exist over a longer trial period and whether patients, their caregivers, and clinicians would find activity level monitoring useful in helping manage PH.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Male or female patients with a diagnosis of Pulmonary Arterial Hypertension (PAH); or inoperable, persistent or recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH),
- •Age ≥ 18 years,
- •Baseline 6 Minute Walk Distance (6MWD) a minimum of 250 meters or maximum 450 meters, (ensure significant Pulmonary Hypertension(PH) without limiting their participation in the trial)
- •WHO Functional Class II or III,
- •Clinically stable patient defined as within the last 12 months (minimum of 3 months) prior to enrollment, there was no:
- •decline in World Health Organization (WHO) Function class or,
- •decline in 6MWD by 15% or,
- •change of oral PAH/CTEPH therapy (may have flexible diuretics/anticoagulation) or,
- •Introduction of parenteral Prostacyclin Analog (PCA) treatment.
- •Patients provide written informed consent, are able to understand and follow instructions.
排除标准
- •Hypersensitivity to nickel (present in the clasp of the FitBit Flex's band),
- •Medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator,
- •Enrolled in pulmonary rehabilitation program within last 6 months,
- •Participating in an interventional study.
结局指标
主要结局
6-minute walk distance (6MWD)
时间窗: At 6 months
(performed by investigator)
Number of steps per day
时间窗: At 6 months
(monitored by Fitbit Flex)
次要结局
- Change in quality of life recorded by patient questionnaire Living with Pulmonary hypertension Questionnaire (LPH)(At baseline, 3 months and 6 months)
- Change in compliance with medication using the Moriky´s Questionnaire(At baseline, 3 months and 6 months)
- Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD(At baseline, 3 months and 6 months)
- Change in Borg Dyspnea value recorded by investigator in conjunction with the 6MWD(At baseline, 3 months and 6 months)
- Healthcare provider Satisfaction and Usability questionnaire(At 3 months and 6 months)
- Caregiver Satisfaction and Usability questionnaire(At 3 months and 6 months)
- Patient Satisfaction and Usability questionnaire(At 3 months and 6 months)