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

Sponsor

University of Aberdeen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04660838

Collaborator

(none)

Enrollment

Location

7.4

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anticholinergic Adverse Reaction	Other: ACB intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jul 17, 2021

Anticipated Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Feb 28, 2022

Outcome Measures

Primary Outcome Measures

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.
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 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 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.
The acceptability of intervention to patients and health care professional stakeholders [3 months]
Semi-structured interviews with patients and health care professionals

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peterculter Medical Practice	Aberdeen		United Kingdom	AB14 0RP

Sponsors and Collaborators

University of Aberdeen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Aberdeen

ClinicalTrials.gov Identifier:

NCT04660838

Other Study ID Numbers:

2-094-20

First Posted:

Dec 9, 2020

Last Update Posted:

Sep 14, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Aberdeen

Anticholinergic burden

Study Results

No Results Posted as of Sep 14, 2021