跳至主要内容
临床试验/NCT04660838
NCT04660838Unknown不适用

Intervention to REduce anticholinerGic burdEN in oldER pATiEnts (REGENERATE) Aged 65 Years and Older: A Non-randomised Feasibility Study

University of Aberdeen2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年7月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
The acceptability of intervention to patients and health care professional stakeholders

研究概览

简要总结

Medications with anticholinergic properties are frequently prescribed for several conditions in older age; for example cardiovascular drugs (e.g. digoxin, furosemide), urologicals (e.g. darifenacin, oxybutynin) and anti-parkinsonism drugs (e.g. benztropine, trihexyphenadyl). It has been shown that increasing anticholinergic burden (ACB) can cause poor health-related outcomes, but there are still uncertainties around whether it is possible or acceptable to stop medication with high ACB and/or switching to another medication with no or low anticholinergic burden, the effect on health-related outcomes of such an approach, the most appropriate person to deliver this intervention or the health care setting in which it should take place.

The term 'deprescribing' is the process of intentionally stopping a medication or reducing its dose to improve the person's health or reduce the risk of adverse side effects. There is, however, limited research regarding deprescribing. Previously, researchers have suggested deprescribing is a systematic process of identifying and discontinuing drugs in instances in which existing or potential harms outweigh existing or potential benefits within the context of an individual patient's care goals, current level of functioning, life expectancy, values, and preferences. However, there are not many studies about implementation of appropriate interventions to reduce ACB in older patients (aged 65 year and over).

The aim of this non-randomised study is to explore the feasibility of delivering an intervention to reduce the ACB in older patients by deprescribing or switching to inform a future definitive clinical trial. This is a single-arm, open feasibility study conducted in primary and secondary care involving older patients. Mixed method (routine data, questionnaires and interviews) will be used in this study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The acceptability of intervention to patients and health care professional stakeholders

时间窗: 3 months

Semi-structured interviews with patients and health care professionals

The number of medication changes recommended and the number implemented

时间窗: 3 months

Time taken to do consultations and acceptance as well as rejection with reasons of doctor from pharmacist recommendations.

The completion rate of baseline and follow up data

时间窗: 3 months

The patients background information, medical history, medications will be recorded at baseline and at 3 months.

The sustainability of intervention (i.e. those remained on same drugs at 6 week and 3 months post intervention)

时间窗: 3 months

Information on patients who remained on reduced regimen and those who went back on the drug or need extra-drug and reasons.

Recruitment of patients from GP practices and hospitals

时间窗: 3 months

The number of patients who are invited to study and the number of patients agree to take part and refuse with reasons.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验