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

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ClinicalTrials.gov Identifier: NCT04660838
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 17, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : February 28, 2022
Arms and Interventions
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Intervention Details:
  • Other: ACB intervention
    Stopping and/or switching ACB medication to an alternative
    Other Name: Stopping and/or switching ACB medication

Outcome Measures
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Primary Outcome Measures :
  1. Recruitment of patients from GP practices and hospitals [ Time Frame: 3 months ]
    The number of patients who are invited to study and the number of patients agree to take part and refuse with reasons.

  2. The completion rate of baseline and follow up data [ Time Frame: 3 months ]
    The patients background information, medical history, medications will be recorded at baseline and at 3 months.

  3. The number of medication changes recommended and the number implemented [ Time Frame: 3 months ]
    Time taken to do consultations and acceptance as well as rejection with reasons of doctor from pharmacist recommendations.

  4. The sustainability of intervention (i.e. those remained on same drugs at 6 week and 3 months post intervention) [ Time Frame: 3 months ]
    Information on patients who remained on reduced regimen and those who went back on the drug or need extra-drug and reasons.

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


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04660838


Contacts
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Contact: Athagran Nakham, Pharm.D. 01224277856 r03an17@abdn.ac.uk

Locations
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United Kingdom
Peterculter Medical Practice Recruiting
Aberdeen, United Kingdom, AB14 0RP
Contact: Valerie Sillito, MPharm    01224733535      
Sponsors and Collaborators
University of Aberdeen
More Information
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Publications:
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.
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].

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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT04660838    
Other Study ID Numbers: 2-094-20
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aberdeen:
Anticholinergic burden