Pharmacist-led Intervention on Hemodialysis Patients' Therapy Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) scores
研究概览
简要总结
A parallel-group, cluster-randomized, controlled trial designed to evaluate if hemodialysis patients benefit from BCT. The study includes two groups: usual care and pharmacist-led intervention groups.
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
- •Adults (≥18 years of age), chronic kidney disease patients on standard in-center hemodialysis for at least three months, patients receiving 4 hours per session, moderate to poor adherence to their therapeutic regimen according to End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) at the time of inclusion
排除标准
- •Switching from hemodialysis to peritoneal dialysis, receiving transplantation during the research period, inability to communicate for any reason (cognitive impairment, hearing and visual loss, etc.), hemodialysis patients with viral hepatitis, and patient refusal to participate.
研究组 & 干预措施
Usual care
The usual care group received the usual care offered by the center to all patients, which included printed, paper-based, and verbal instructions. The written material included knowledge about diet recommendations for dialysis patients based on National Kidney Foundation recommendations. Verbal instructions were provided by the physician, including information regarding their medications, dialysis, diet, and fluid intake based on their condition and monthly lab results. Medications are provided to all patients at no cost, and pharmacists provide instructions on how to use them.
pharmacist-led behavioral change technique
The intervention was developed based on the behavior change technique taxonomy (v1). This intervention was designed to improve adherence to all therapeutic aspects of hemodialysis patients, including the dialysis program, medications, diet, and fluids. Additionally, the effect of the pharmacist intervention on physiological indices (serum potassium, total calcium, phosphate, IDWG, and hemoglobin) was examined.
The program was explicitly created for implementation in an actual setting, ensuring that the time allocation for participants and facilitators (the party responsible for conducting the PL-BCT) remained reasonable in most contexts.
The BCT components were developed after the identification and coding of the BCTs from previous interventional studies that contain behavioral components and result in positive effects on one or more hemodialysis patients' adherence domains toward their therapeutic regimen (dialysis program, medications, diet, and fluid).
干预措施: Pharmacist led behavioral change technique (Behavioral)
结局指标
主要结局
End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) scores
时间窗: At the start of the study, and after one month of the start of the study.
The ESRD-AQ is a comprehensive tool that records critical elements of patients' treatment history: self-reported treatment adherence (including HD attendance, prescriptions, fluid restrictions, and dietary recommendations); perceptions regarding adherence behaviors; and justifications for nonadherence. ESRD-AQ consists of 46 questions, scores range from 0 to 1,200, with higher scores signify better adherence. Scores are divided into three ranges to identify adherence behavior (good adherence scores range between 1000 to 1200, moderate adherence scores range between 700 to 999, and poor adherence scores are less than 700). The scores were distributed over the four dimensions as follows: adherence to HD sessions (scores 0 - 600), adherence to dietary recommendations (scores 0 - 200), adherence to medications (scores 0 - 200), and adherence to fluid restriction (scores 0 - 200)
次要结局
- Total serum Calcium(At the start of the study, and after one month of the start of the study.)
- Hemoglobin levels(At the start of the study, and after one month of the start of the study.)
- Serum Phosphate(At the start of the study, and after one month of the start of the study.)
- Interdialytic weight gain (IDWG)(At the start of the study, and after one month of the start of the study.)
研究者
Thuraya Safaa Ibrahim
Principal Investigator
University of Baghdad