Self-management of Heparin Therapy - Drug Use Problems and Compliance With Self-injected Low Molecular Weight Heparin in Ambulatory Care
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 4
- 主要终点
- Drug Use Problems
研究概览
简要总结
There is very little data available on compliance with self-injected low molecular weight heparins (LMWH), but what there is, definitely shows that compliance represents a significant problem. We therefore aim to a) record drug use problems of patients including compliance, b) develop a "SOP" for first instruction by a pharmacist and for subsequent pharmaceutical care and c) to compare intensive pharmaceutical care (intervention) vs. standard care (control) provided in the pharmacy to patients with a prescription for a LMWH as an outpatient treatment.
Hypothesis:
Intensive pharmaceutical care in ambulatory patients who self-inject low molecular weight heparins results in improved compliance, more safety and satisfaction as well as in fewer complications.
详细描述
Patient recruitment in community pharmacies enables the testing of the feasibility of the interventions under daily-practice conditions and facilitates the recruitment of a larger number of patients.
Data collection:
- telephone interviews with structured questionnaires at the beginning and at the end of the therapy
- monitored self-injection in the study center or at patient's home (direct observation technique [DOT])
- compliance measurement: answers from patient interviews, comparing number of used syringes vs. number of prescribed syringes (analogue "pill count"), measuring residual volume in recycled syringes
- recording of the fine motor skills by the adapted "Disabilities of the Arm, Shoulder and Hand" questionnaire (DASH questionnaire)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients are recruited from orthopedic clinics, an emergency department and from community pharmacies with a prescription for a LMWH as an outpatient treatment.
- •self-application of the LMWH
- •german / english speaking
- •> clinical setting:
- •Dalteparin
- •> daily life setting:
- •all LMWH (ready-to-use syringes)
- •control group: self-application or application by another person (family member, medical person, etc.)
排除标准
- •- patient's home far away from study center
研究组 & 干预措施
clinical setting: intervention
Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.
Intervention: patient education
干预措施: patient education (Behavioral)
clinical setting: standard care
Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
daily life setting: intervention
Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.
Intervention: patient education
干预措施: patient education (Behavioral)
daily life setting: standard care
Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
结局指标
主要结局
Drug Use Problems
时间窗: during the individual drug therapy, an average of 18 days
During a home visit and at her/his individual injection time, each patient was monitored when self-administering an s.c. injection (directly observed therapy, DOT). Score minimum = -2.00; score maximum = +2.00 for the objective estimation of the application quality. Higher score values represent better outcomes.
次要结局
- Compliance(at the end of the individual drug therapy, an average of 18 days)
- Patient Satisfaction(at the end of the individual drug therapy, an average of 18 days)