Implementation of a Remote Home Monitoring Program for Patients With a Mild Acute Pancreatitis - A Single Center Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Patient satisfaction with wearable sensor (Healthdot), based on satisfaction questionnaire
研究概览
简要总结
Acute pancreatitis is an inflammation of the pancreas which causes abdominal pain and is the most common gastro-intestinal reason for acute hospitalization in Western countries. Because care for patients with a mild acute pancreatitis is mostly supportive, providing this care in the home environment may be feasible with the use of remote monitoring. This might reduce the demand for hospital beds and allow patients to benefit from recovering in their home environment. Therefore, the objective of this single center study is to assess the feasibility of a novel care program in which patients with a predicted mild course of acute pancreatitis are discharged early with remote home monitoring.
Patients, with a predicted mild course of acute pancreatitis. Patients with prior acute pancreatitis within 3 months or a chronic pancreatitis are excluded from participation. Patients should be ≥18 years of age. The goal is to include a total of 70 patients. After at least 48 hours of hospital admission, patients are discharged early with the use of remote home monitoring. At home, patients receive guidance for the management of pain, nutrition and pancreatitis-related complaints by a daily phone call from a nurse from the Virtual Monitoring Centre (VMC). The pancreatitis-related complaints, intake of fluids and food, pain and the use of analgesics are assessed using short questionnaires in a smartphone app. Core temperature is monitored using an ear thermometer and a wearable sensor measures heart rate, respiratory rate, posture and movement every 5 minutes. Remote home monitoring will continue for at least 4 days.
The main study objective is to assess the feasibility of the novel care program. Feasibility is determined by, patient satisfaction and actual use of the novel care program. The secondary study objective is to describe clinical outcomes of patients in the novel care program.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute pancreatitis according to the revised Atlanta criteria for pancreatitis(23). Which is at least 2 of the following 3 criteria:
- •Abdominal pain consistent with acute pancreatitis
- •Serum lipase ≥ 3x upper limit normal (> 159 U/l)
- •Typical pancreatic abnormalities on imaging (ultrasound, CT or MRI)
- •First episode of acute pancreatitis or a prior pancreatitis more than 3 months ago
- •Age ≥18 years, both men and women
- •Able and willing to provide written informed consent in Dutch
- •In possession of a working (smart)phone on which patient can be reached for the duration of participation (30 days)
- •≤1 SIRS criteria
- •Temperature < 36◦C or > 38◦C
- •Heart rate >90/min
- •Respiratory rate >20/min
- •Leucocytes < 4x/109/L or > 12x109/L
- •Serum CRP ≤ 150 mg/l on day of discharge and with a decreasing trend in days before
- •Pain score (NRS) ≤6 with or without the use of pain medication
- •Adequate intake of oral food and fluids (= ≥2 small meals and ≥1L fluids per day)
- •Stable serum creatinine and Ringer's lactate infusion reduced to ≤1L/24 hours
- •Independent in performing general daily life activities
排除标准
- •Chronic pancreatitis according to M-ANNHEIM criteria(24).
- •Acute cholangitis
- •Endoscopic retrograde cholangiopancreatography within the first 24 hours of admission
- •MEWS (Modified Early Warning Score) ≥6 or in need of ICU admission
- •Living in an institution (e.g. psychiatric ward or nursing home), or the absence of a household member capable of alerting the hospital in case of an emergency Known sensitivity to medical adhesives
- •Known pregnancy
- •Have one or more of the following comorbidities:
- •Heart failure (NYHA class III or IV)
- •COPD (Gold III-IV)
- •Kidney disease (>G3b) and/or kidney replacement therapy
- •Currently undergoing oncological treatment
- •Use of immunosuppressants
- •Dysregulated or poorly controlled insulin dependent diabetes
- •Morbid obesity (BMI>35 kg/m2)
- •Implantable Cardioverter Defibrillator (ICD) or Pacemaker
结局指标
主要结局
Patient satisfaction with wearable sensor (Healthdot), based on satisfaction questionnaire
时间窗: Within 30 days of hospital admission
Patient satisfaction with overall care, based on satisfaction questionnaire
时间窗: Within 30 days of hospital admission
Overall care from GE-ward admittance until discontinuation of remote home monitoring.
Patient satisfaction with smartphone app (Luscii), based on satisfaction questionnaire
时间窗: Within 30 days of hospital admission
Duration of remote home monitoring in days
时间窗: Within 30 days of hospital admission
Wearable sensor functionality, determined by the amount of missing data and accidental detachments
时间窗: Within 30 days of hospital admission
Proportion of patients willing and able to participate
时间窗: Within 30 days of hospital admission
Time between discharge decision and actual hospital discharge in days
时间窗: Within 30 days of hospital admission
Number of contacts between patients and healthcare professionals
时间窗: Within 30 days of hospital admission
Patient intent to participate in the care program again
时间窗: Within 30 days of hospital admission
Based on satisfaction questionnaire
Number of additional laboratory tests (during home monitoring)
时间窗: Within 30 days of hospital admission
Smartphone app functionality, determined by generated notifications, time between notification and contact with VMC-nurse and questionnaire compliance
时间窗: Within 30 days of hospital admission
次要结局
- Pain scores, based on NRS (0-10)(Within 30 days of hospital admission)
- Intake of food and fluids, described as number of meals and liters of fluid intake(Within 30 days of hospital admission)
- Emergency department (ED) revisits(Within 30 days of hospital admission)
- Activity levels, as measured by the wearable sensor (0-10)(Within 30 days of hospital admission)
- Pancreatitis-related complications(Within 30 days of hospital admission)
- Use of analgesics and anti-emetics, described as the number of days used(Within 30 days of hospital admission)
- Time between GE ward admission and discharge decision in days(Within 30 days of hospital admission)
- Hospital readmissions(Within 30 days of hospital admission)