NCT04660838: REGENERATE

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

Status unknown NA Last updated 14 September 2021

What this trial tests

NA trial testing ACB intervention in Anticholinergic Adverse Reaction in 40 participants. Status unknown.

Timeline

17 July 2021

Primary endpoint
30 September 2021

28 February 2022

Quick facts

Lead sponsor	University of Aberdeen
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	40
Start date	17 July 2021
Primary completion	30 September 2021
Estimated completion	28 February 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• ACB intervention

Conditions studied

• Anticholinergic Adverse Reaction — all drugs for Anticholinergic Adverse Reaction →

Sponsor

University of Aberdeen

Who can join

Adults 65 to 100, any sex, with Anticholinergic Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The REGENERATE Study: A Non-Randomized Feasibility Study of an Intervention to REduce anticholinerGic burdEN in oldER pATiEnts.
   Nakham A, Bond C, Cruickshank M, Newlands R, et al · · 2024 · PMID 39727811 · DOI 10.3390/geriatrics9060152
2. The Regenerate Study: A Non-randomised Feasibility Study of an Intervention to Reduce Anticholinergic Burden in Older Patients
   Nakham A, Bond C, Cruickshank M, Newlands R, et al · · 2024 · DOI 10.20944/preprints202409.1171.v1