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临床试验/NCT06142838
NCT06142838招募中不适用

Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators

University Ghent1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2023年10月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,600
试验地点
1
主要终点
NIH Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS)

研究概览

简要总结

The goal of this clinical trial is to evaluate a community pharmacist intervention aimed at improving medication adherence in patients starting newly prescribed medication for cardiovascular disease prevention. The main questions it aims to answer are:

  • Does this community pharmacist intervention improve medication adherence?
  • Which patients benefit the most from the intervention?
  • How do patients experience the start-up of newly prescribed medication (which questions do they have and do they experience side effects?)?
  • How do patients and pharmacists experience the intervention?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

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 presenting with a first prescription for one of the following drug classes: antihypertensive drugs (= low-ceiling diuretics, beta blocking agents (excl. non-selective beta-blocking agents), ACE inhibitors, angiotensin II receptor blockers, calcium channel blockers), lipid-lowering drugs (= statins), antidiabetic drugs (= metformin, glucagon-like peptide-1 (GLP-1) analogues, sodium-glucose co-transporter 2 (SGLT2) inhibitors), or any combination thereof.
  • •Age 18 years or older
  • •Community-dwelling

排除标准

  • •The drug is prescribed for a non-cardiovascular indication (e.g. beta-blocking agent for migraine prophylaxis)
  • •Communication with the patient is not possible (e.g. due to cognitive impairment, insufficient knowledge of Dutch or French language)

研究组 & 干预措施

Control arm

No Intervention

Usual care

Intervention arm

Experimental

Community pharmacist intervention

干预措施: community pharmacist intervention (Behavioral)

结局指标

主要结局

NIH Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS)

时间窗: At 6 weeks and at 12 weeks follow-up

Patient-reported measure of medication adherence

次要结局

  • Healthcare utilization(Over 12 weeks post-baseline)
  • Medication Possession Ratio (MPR)(Over 26 weeks post-baseline)
  • Medication knowledge questionnaire(At 6 weeks and at 12 weeks follow-up)
  • Treatment response(At baseline and at 12 weeks follow-up)
  • Discontinuation rate(Over 26 weeks post-baseline)
  • Beliefs about Medicines Questionnaire (BMQ-Specific)(At 6 weeks and at 12 weeks follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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