A Nurse-led Multifactorial Intervention to Improve Phosphate Binder Adherence: Results From a One-year Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 3
- 主要终点
- Medication adherence
研究概览
简要总结
The study aim is to test the efficacy of one-year nurse-led interventions to improve the medication intake behaviour of chronic dialysis patients. The investigators hypothesis is the interventions leading to a 15% mean increase in intake, compared to standard care.
详细描述
Background Phosphate binder nonadherence is ubiquitous. The results of adherence enhancing interventions are often disappointing. The aim is to test a nurse-led multifactorial intervention to enhance phosphate binder adherence.
Methods In a quasi-experimental clinical trial, phosphate binder adherence was measured electronically in 135 hemodialysis patients for one year and phosphatemia measured monthly. For all patients, months 1-2 were baseline (no interventions were performed). The intervention arm was given 1 "preparatory" intervention and then monthly 8 "maintenance" individualized management sessions. The control arm received standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •adult (≥18)
- •chronic hemodialysis ≥1 month
- •treated with phosphate binders
- •Dutch-speaking
排除标准
- •receiving professional medication care
- •cognitive impairment
- •nursing home residents
研究组 & 干预措施
Adherence support
One-time preparatory intervention offering adherence prerequisites (knowledge, social support and skills)
- One-year monthly individualised counselling sessions with a standardised intervention sheet listing the most prevalent problems with possible solutions
干预措施: Adherence support (Behavioral)
Control arm
Standard care
结局指标
主要结局
Medication adherence
时间窗: One year
The intake of medication (phosphate binders) was monitored continuously for one year through electronic monitoring with the Medication Event Monitoring System (MEMS). Medication containers are filled with patients' phosphate binders and then capped with MEMS-caps registering the time and date of each opening and thus presumed intake of the medication in the box. Mean adherence was calculated as the proportion of prescribed doses taken, averaged per month (e.g. patients with a ter in die regimen (84 doses/month) and taking them all 84 would have a mean adherence of 84/84=100%). Nonadherence was defined as a mean adherence \<80%.
次要结局
- Serum phosphate(Monthly for one year)
- Patient knowledge(At study start and end (after one year))
- Social support(At study start and end (after one year))
研究者
Yoleen Van Camp
Dra.
Universiteit Antwerpen