AzTrials
AzTrials

Anticholinergic Adverse ReactionREGENERATENCT04660838

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

A study testing ACB intervention in people with Anticholinergic Adverse Reaction, run by University of Aberdeen at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 65 to 100 years
Conditions the study is for
Anticholinergic Adverse Reaction
What is being tested?
ACB intervention
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
17 Jul 2021to 28 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 100 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

None listed.

Who cannot join

  • Participants who cannot understand English fluently

Trial locations and contacts

1 site in 1 country.

Athagran Nakham, Pharm.D. contact

01224277856

r03an17@abdn.ac.uk

United Kingdom1 site, 1 recruiting

  • Peterculter Medical Practice

    Aberdeen, AB14 0RP

    Valerie Sillito, MPharm, 01224733535

    Recruiting

Other trials in United Kingdom

About this study

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

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.

Being tested
ACB intervention
Keywords
Anticholinergic burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACB interventionOther

    Also called Stopping and/or switching ACB medication

    Stopping and/or switching ACB medication to an alternative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment of patients from GP practices and hospitals

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

    Measured: 3 months

  2. The completion rate of baseline and follow up data

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

    Measured: 3 months

  3. The number of medication changes recommended and the number implemented

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

    Measured: 3 months

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

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

    Measured: 3 months

  5. The acceptability of intervention to patients and health care professional stakeholders

    Semi-structured interviews with patients and health care professionals

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start17 Jul 2021
  3. Primary completion30 Sep 2021 (estimated)
  4. Study completion28 Feb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04660838
Sponsor's protocol ID
2-094-20
Acronym
REGENERATE
Status last verified
Sep 2021
First submitted
1 Dec 2020
Last updated
14 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Best O, Gnjidic D, Hilmer SN, Naganathan V, McLachlan AJ. Investigating polypharmacy and drug burden index in hospitalised older people. Intern Med J. 2013 Aug;43(8):912-8. doi: 10.1111/imj.12203.

    PubMed 23734965

  • BOUSTANI, M., CAMPBELL, N., MUNGER, S., MAIDMENT, I. and FOX, C., 2008. Impact of anticholinergics on the ageing brain: a review and practical application. Aging Health, 4(3), pp. 311-320.

  • Cancelli I, Beltrame M, Gigli GL, Valente M. Drugs with anticholinergic properties: cognitive and neuropsychiatric side-effects in elderly patients. Neurol Sci. 2009 Apr;30(2):87-92. doi: 10.1007/s10072-009-0033-y. Epub 2009 Feb 20.

    PubMed 19229475

  • Feinberg M. The problems of anticholinergic adverse effects in older patients. Drugs Aging. 1993 Jul-Aug;3(4):335-48. doi: 10.2165/00002512-199303040-00004.

    PubMed 8369593

  • Fox C, Smith T, Maidment I, Chan WY, Bua N, Myint PK, Boustani M, Kwok CS, Glover M, Koopmans I, Campbell N. Effect of medications with anti-cholinergic properties on cognitive function, delirium, physical function and mortality: a systematic review. Age Ageing. 2014 Sep;43(5):604-15. doi: 10.1093/ageing/afu096. Epub 2014 Jul 19.

    PubMed 25038833

  • Gorup E, Rifel J, Petek Ster M. Anticholinergic Burden and Most Common Anticholinergic-acting Medicines in Older General Practice Patients. Zdr Varst. 2018 Jun 21;57(3):140-147. doi: 10.2478/sjph-2018-0018. eCollection 2018 Jun.

    PubMed 29983780

  • Green AR, Reifler LM, Bayliss EA, Weffald LA, Boyd CM. Drugs Contributing to Anticholinergic Burden and Risk of Fall or Fall-Related Injury among Older Adults with Mild Cognitive Impairment, Dementia and Multiple Chronic Conditions: A Retrospective Cohort Study. Drugs Aging. 2019 Mar;36(3):289-297. doi: 10.1007/s40266-018-00630-z.

    PubMed 30652263

  • Kersten H, Molden E, Tolo IK, Skovlund E, Engedal K, Wyller TB. Cognitive effects of reducing anticholinergic drug burden in a frail elderly population: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2013 Mar;68(3):271-8. doi: 10.1093/gerona/gls176. Epub 2012 Sep 14.

    PubMed 22982689

  • Lopez-Alvarez J, Sevilla-Llewellyn-Jones J, Aguera-Ortiz L. Anticholinergic Drugs in Geriatric Psychopharmacology. Front Neurosci. 2019 Dec 6;13:1309. doi: 10.3389/fnins.2019.01309. eCollection 2019.

    PubMed 31866817

  • Nakham A, Myint PK, Bond CM, Newlands R, Loke YK, Cruickshank M. Interventions to Reduce Anticholinergic Burden in Adults Aged 65 and Older: A Systematic Review. J Am Med Dir Assoc. 2020 Feb;21(2):172-180.e5. doi: 10.1016/j.jamda.2019.06.001. Epub 2019 Jul 24.

    PubMed 31351858

  • OLASEHINDE-WILLIAMS, O., July, 2020-last update, Deprescribing guide. Available: https://southendccg.nhs.uk/your-health-services/healthcare-professionals/medicines-management/medicines-management-resources/2308-deprescribing-guide/file [April/03, 2020].

  • Reeve E, Shakib S, Hendrix I, Roberts MS, Wiese MD. The benefits and harms of deprescribing. Med J Aust. 2014 Oct 6;201(7):386-9. doi: 10.5694/mja13.00200.

    PubMed 25296058

Questions about this trial

What is this clinical trial studying?

A study testing ACB intervention in people with Anticholinergic Adverse Reaction, run by University of Aberdeen at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Athagran Nakham, Pharm.D. (01224277856, r03an17@abdn.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment of patients from GP practices and hospitals (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04660838, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in