Feasibility and Safety of Home Blood Count Measurement and Transfusions by Systematically Educated Patients With Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Technical Performance of the Hemoscreen Instrument
研究概览
简要总结
The aim is to investigate the feasibility, safety, and complication rates of patient's self-measurement of CBC and self-administration of blood and platelet transfusions at home and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion. Furthermore, to evaluate the health economic consequences of our innovative approach, specifically, the anticipated reduction in reliance on nurse-driven services.
This study is a single-arm feasibility study with patients newly diagnosed with Acute Myeloid Leukemia. The study will be conducted at the Department of Hematology, Rigshospitalet.
Patients are included if they are ≥ 18 years old, newly diagnosed with AML within four weeks, and scheduled to receive home-based chemotherapy. Patients are excluded if they do not speak Danish or are not assessed to be capable of performing home-based CBC measurements and administration of transfusions. Patients will be discontinued if they do not achieve remission after the second chemotherapy cycle.
Included patients will receive comprehensive training and certification to perform CBC measurements, self-administer transfusions, and monitor selected vital parameters including blood pressure, pulse rate, oxygen saturation, and temperature.
It is hypothesized that the study can demonstrate the logistic, technical, and economic feasibility and safety of educating patients with AML undergoing intensive chemotherapy, to independently conduct self-measurement of complete blood count (CBC), self-administration of transfusions at home, and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion.
详细描述
Acute Myeloid Leukemia is a serious blood cancer treated with intensive chemotherapy. Around 150 patients in Denmark receive such treatment annually. Each patient undergoes 2-4 chemotherapy cycles, each followed by a 3-4 week period of bone marrow suppression, requiring frequent blood and platelet transfusions and increasing infection risk. Patients with acute myeloid leukemia, experience prolonged chemotherapy-induced pancytopenia, lasting between 2 to 4 weeks. In our existing outpatient treatment setup, patients visit the day hospital 3 times weekly for blood measurements, clinical evaluation, and transfusions with blood and platelets.
Transfusion reactions are rare, and serious complications are even less common. While some studies have explored home transfusions administered by healthcare professionals or relatives, no studies have examined self-administered home transfusions.
Patient involvement is increasingly important in cancer care. Understanding patient experiences is key to implementing safe and successful home-based care, especially in long-term, intensive treatments. Maintaining daily life and being with loved ones during treatment are highly valued by patients and families.
In this study, we aim to instruct patients to perform complete blood count measurements and self-administration of transfusions at home, thereby reducing the need for weekly visits to the hospital. However, patients will still be required to come into the hospital for blood measurements, clinical control with their responsible physician, and transfusions once weekly.
Objective To investigate the feasibility, safety, and complication rates of patients self-measurement of complete blood count and self-administration of blood and platelet transfusions at home and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion. Furthermore, to evaluate the health economic consequences of our innovative approach, specifically, the anticipated reduction in reliance on nurse-driven services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •≥ 18 years old
- •newly diagnosed with AML within four weeks
- •scheduled to receive home-based chemotherapy.
排除标准
- •Patients who do not understand or speak Danish
- •Incapable of performing home-based CBC measurements and administration of transfusions.
- •Patients will be discontinued if they do not achieve remission after the second chemotherapy cycle.
研究组 & 干预措施
Feasibility
Feasibility and safety of home-based blood count measurement and transfusions
干预措施: Feasibility and safety of home-based blood count measurement and transfusions (Device)
结局指标
主要结局
Technical Performance of the Hemoscreen Instrument
时间窗: Assessed throughout each participant's enrollment period, up to 12 weeks.
Number and classification of technical issues encountered by patients using the Hemoscreen instrument, including device malfunctions, failures, and errors in transmission of complete blood count (CBC) measurements. Recorded per transfusion event through hospital records and patient reports; categorized by issue type (e.g., hardware failure, data transmission error).
Self-Administered Blood Measurements at Home
时间窗: Recorded continuously during each participant's enrollment, up to 12 weeks.
Number of CBC measurements performed by patients at home using the Hemoscreen instrument. Extracted from hospital records and participants' self-reporting.
Self-Administered Blood and Platelet Transfusions at Home
时间窗: Recorded continuously during each participant's enrollment, up to 12 weeks.
Number of blood and platelet transfusions self-administered at home without direct hospital supervision. Extracted from hospital records and participants' self-reporting.
Replacement of Scheduled Day Hospital Visits by Home Care and Self-Testing
时间窗: Recorded continuously during each participant's enrollment, up to 12 weeks.
Number of scheduled day hospital visits replaced by successful self-testing and home transfusions. Determined by comparing hospital visit records with home care study documentation.
Vital Signs Before and After Home Transfusions
时间窗: Recorded at each home transfusion event during the participant's 12-week enrollment.
Vital parameters including temperature (°C), pulse rate (beats per minute), and blood pressure (mmHg) measured immediately before and after each home transfusion. Measurement: Collected by participants using standardized home monitoring devices and confirmed during nursing visits.
Extra Healthcare Visits and Hospital Admissions
时间窗: Recorded continuously during each participant's enrollment, up to 12 weeks.
Number, cause, and duration (days) of unplanned extra visits to the day hospital or inpatient ward related to transfusion or device complications. Data collected from hospital records.
Transfusion Reactions and Adverse Events
时间窗: Assessed continuously during and for 24 hours post-transfusion within each participant's study period, up to 12 weeks.
Number and severity of transfusion reactions, including serious infusion reactions necessitating hospital admission. Documented by clinicians and participant self-reporting; hospital admissions verified through records.
Types of Transfusion Reactions
时间窗: Recorded at each transfusion event during each participant's enrollment up to 12-week study period.
Frequency and types of transfusion reactions, categorized as fever, shivering, hypotension, hypertension, hives, nausea, pain, malaise, allergic reactions, or others. Recorded using a standardized transfusion reaction form during clinical assessments and participant self-reports.
次要结局
- Change in Quality of Life scores from EORTC QLQ-C30 at baseline and post-second chemotherapy(Assessed over the course of each participant's study period, approximately 12 weeks.)
- Empowerment(Assessed over the course of each participant's study period, approximately 12 weeks.)
研究者
Iben Husted Nielsen
Clinical nurse specialist, PhD
Rigshospitalet, Denmark