Intervention to REduce anticholinerGic burdEN in oldER pATiEnts (REGENERATE) Aged 65 Years and Older

Not Applicable

• Conditions: Anticholinergic Adverse Reaction

• Registration Number: NCT04660838
• Lead Sponsor: University of Aberdeen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-09
• Study Start: 2021-07-17
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-14
• Primary Completion: 2021-09-30
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The acceptability of intervention to patients and health care professional stakeholders	3 months	Semi-structured interviews with patients and health care professionals
The number of medication changes recommended and the number implemented	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	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)	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	3 months	The number of patients who are invited to study and the number of patients agree to take part and refuse with reasons.

Trial Locations

Locations (1)

Peterculter Medical Practice; 🇬🇧 Aberdeen, United Kingdom