Project VOICE: Vascular Outcomes Improvement Through Collection of PatiEnt Reported Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Walking adherence (days with walking exercise/total days per study period)
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of a digital health platform coupled with walking activity tracking for patients with Peripheral Artery Disease (PAD) and symptoms limited to claudication.
详细描述
This is a two center, non-blinded, 2 period randomized crossover trial. 50 patient subjects are planned. Patient participants will be identified and recruited from clinical environments (including clinics and diagnostic testing departments) at participating sites. Diagnosis and testing will occur through usual clinical care, and participants will not incur financial costs related to participation. A crossover design will be utilized, where all participants will use the VOICE platform with activity tracking for 35 days and usual care for 30 days. Randomization will determine the order in which participation in the VOICE phase versus the usual care phase occur. Randomization will occur using a closed envelope system. For patients in the VOICE platform group, data collection will occur over a total of 35 days, including an initial 5-day "run in" period during which participants will orient themselves to the system. Each provider participant will receive a single end-user survey evaluating VOICE from their perspective.
Screening of patients electronic medical records will be done to determine subject eligibility. Subjects who meet all inclusion criteria will be approached to participate.
Total duration of subject participation will be 9 weeks during the control and intervention phases, with a final follow-up survey at 6 months post-enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of symptomatic PAD with claudication
- •Ankle- brachial index (ABI) ≤ 0.9 or non-compressible leg arteries
- •Walking exercise therapy recommended as treatment for PAD by the healthcare provider
- •Willingness to be randomized to VOICE platform or control group
- •Ability to access the internet
- •Willing to sign an informed consent
排除标准
- •Walking exercise therapy not recommended due to contraindication or any other reason
- •Wheelchair dependence or inability to walk unassisted
- •Presence of foot ulcers, wounds, or gangrene
- •History of major extremity amputation
- •Lack of objective physiologic data validating PAD diagnosis
- •Claudication symptoms due to diagnoses other than PAD (i.e., popliteal entrapment syndrome)
- •Inability to speak or read English
- •Severe mental illness
- •Inability to give informed consent
结局指标
主要结局
Walking adherence (days with walking exercise/total days per study period)
时间窗: 2 months
Self-reported walking adherence based on a daily log will be compared with exercise assessed using tracked walking activity during the VOICE/Fitbit phase. Adherence will be evaluated based on number of days during the study period where walking exercise was performed, and will be evaluated as a categorical (yes/no) variable.
次要结局
- Tracked Walking Activity: Distance (meters)(2 months)
- Tracked Walking Activity: Steps (count)(2 months)
- Tracked Walking Activity: Time (minutes)(2 months)
- Tracked Walking Activity: Cadence (steps per minute)(2 months)
- Sleep interruption (mean nightly frequency)(2 months)
- PROMIS Pain Interference Short Form 6a (raw score, T-score conversion)(1 month, 2 months, 6 months)
- PROMIS Physical Function Short Form 6b (raw score, T-score conversion)(1 month, 2 months, 6 months)
- PROMIS Sleep Disturbance Short Form 4a (raw score, T-score conversion)(1 month, 2 months, 6 months)
- VascuQol-6(1 month, 2 months, 6 months)
研究者
Matthew Corriere
Associate Professor
University of Michigan