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

Anticholinergic Adverse Reaction Clinical Trial

— REGENERATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04660838
• Other study ID #: 2-094-20
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: September 2021
• Source: University of Aberdeen
• Contact: Athagran Nakham, Pharm.D.
• Phone: 01224277856
• Email: r03an17[@]abdn.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 28, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

Inclusion Criteria for stopping and/or switching medications

Patients who are:

• aged 65 and over

• able to provide informed consent.

• on one or more long-term drugs (have been prescribed a minimum 6 weeks) with ACB potential (Anticholinergic Cognitive Burden scale =3) (defined according to Boustani et al (Boustani, Campbell et al. 2008)

Exclusion Criteria for stopping and/or switching medications

Patients who:

• are without capacity to provide informed consent.

• have severe mental illness [such as diagnosis of severe anxiety, severe depression, severe dementia etc.].

• are terminally ill (life expectancy less than 6 months).

• in opinion of responsible clinician are not suitable.

• are taking part in another study.

Health care professional inclusion criteria for interviews

• Professionals: doctors (consultants, GPs), pharmacist in primary and secondary care involved in the care of patients aged 65 and over on polypharmacy regimes/likely to have anticholinergic burden and have taken part in the study by delivering the intervention

Patients inclusion criteria for interviews

• Patients: patients aged 65 years and over who met eligible criteria and have taken part in the REGENERATE study will be selected.

Exclusion criteria for interviews

• Participants who cannot understand English fluently

Related Conditions & MeSH terms

• Anticholinergic Adverse Reaction

Intervention

Other:
• ACB intervention
Stopping and/or switching ACB medication to an alternative

Locations

Country	Name	City	State
United Kingdom	Peterculter Medical Practice	Aberdeen

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

References & Publications (12)

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. — View Citation

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. Review. — View Citation

Feinberg M. The problems of anticholinergic adverse effects in older patients. Drugs Aging. 1993 Jul-Aug;3(4):335-48. Review. — View Citation

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. Review. — View Citation

Gorup E, Rifel J, Petek Šter 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. — View Citation

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. — View Citation

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. — View Citation

López-Álvarez J, Sevilla-Llewellyn-Jones J, Agüera-Ortiz L. Anticholinergic Drugs in Geriatric Psychopharmacology. Front Neurosci. 2019 Dec 6;13:1309. doi: 10.3389/fnins.2019.01309. eCollection 2019. Review. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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.	3 months
Primary	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.	3 months
Primary	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.	3 months
Primary	The acceptability of intervention to patients and health care professional stakeholders	Semi-structured interviews with patients and health care professionals	3 months