跳至主要内容
临床试验/NCT04195191
NCT04195191Unknown不适用

Effectiveness of an Intervention to Improve the Adherence to Treatment of New Medicines From the Community Pharmacy

Andalusian School of Public Health1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Adherence to treatment

研究概览

简要总结

The ANM is the first initiative that puts advanced pharmaceutical care into practice in Andalusia (Spain). The aim of this is study is to evaluate the effectiveness of the intervention Assistance to New Medicines (ANM) in the improvement of adherence to treatment in community pharmacies.

详细描述

Design: parallel cluster pragmatic randomized controlled trial. The study includes patients users of a community pharmacies, who meet the following inclusion criteria: patient who starts treatment of any of the following pathologies: Chronic Obstructive Pulmonary Disease (COPD), Arterial Hypertension or Diabetes Mellitus in Andalusia (Spain).

In order to avoid possible contamination between patients assigned to the control and intervention group, randomization will be carried out at the pharmacy level; preventing the pharmacist from applying part of the intervention to the control group.

Interventions: patients randomized: (i) current practice; or (ii) ANM intervention thru a pharmacist delivered support for a newly prescribed medicine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

The statistical analysis will be performed by a person who would be blinded to which arm were assigned the subjects.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •patient who starts treatment of any of the following diseases:
  • •Chronic Obstructive Pulmonary Disease (COPD).
  • •Arterial Hypertension
  • •Diabetes Mellitus.
  • •Anticoagulants

排除标准

  • •those users who do not know how to read and write in Spanish,
  • •Suffer from a physical or mental disorder that makes it impossible to perform the

研究组 & 干预措施

Placebo

Placebo Comparator

The usual practice by community pharmacies

干预措施: Placebo (Other)

ANM

Experimental

This is an intervention based on pharmaceutical-patient communication through an open and fluid conversation, aimed at evaluating the patient's relationship with their new prescription, detecting possible problems, concerns and false beliefs or visual expectations.

干预措施: ANM (Other)

结局指标

主要结局

Adherence to treatment

时间窗: Six months

adherence to treatment may be defined as the extent to which the patient's history of therapeutic drug-taking coincides with the prescribed treatment.

Adherence to treatment

时间窗: Ten weeks

adherence to treatment may be defined as the extent to which the patient's history of therapeutic drug-taking coincides with the prescribed treatment.

次要结局

  • Satisfaction with the service(Ten weeks and six months)

研究者

发起方
Andalusian School of Public Health
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Intervention to Improve the Adherence in Community... | 临床试验