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NCT04270474 | RECRUITING | Dementia

Reducing Risk of Dementia Through Deprescribing
Sponsor:

Indiana University

Information provided by (Responsible Party):

Noll Campbell

Brief Summary:

A cluster-randomized controlled trial (RCT) called "Reducing Risk of Dementia through Deprescribing" (R2D2) to evaluate the impact of a deprescribing intervention on important cognitive and safety outcomes.

Condition or disease

Dementia

Alzheimer Disease, Late Onset

Intervention/treatment

Deprescribing of target anticholinergics

Usual Care

Phase

NA

Detailed Description:

The R2D2 study will test whether the adverse cognitive effects of anticholinergic medications are reversible by implementing a pharmacist-based deprescribing intervention for older adults within primary care practices. Two groups will be recruited: providers (physicians and advanced practice providers including nurse practitioners), and patients. Primary care providers of those prescribed eligible anticholinergic medications will be recruited for participation in the study, and their patients who also meet eligible criteria will be subsequently approached and recruited. Participants will be randomized to one of two groups: the deprescribing intervention group or usual care; the intervention group will receive a pharmacist-based deprescribing intervention, while the usual care group will receive care as usually provided by their primary and/or specialty care providers. The intervention and follow-up data collection will occur over 24 months in order to test the long-term impact of the intervention on the planned clinical outcomes. Study outcomes include cognition (primary) and safety (secondary) through validated self-reported scales.

Study Type : INTERVENTIONAL
Estimated Enrollment : 344 participants
Masking : DOUBLE
Masking Description : The principle investigator and all outcome assessor will be blinded to the arm assignment of the subjects. No access to unblinded data will be provided to blinded staff.
Primary Purpose : PREVENTION
Official Title : Reducing Risk of Dementia Through Deprescribing (R2D2)
Actual Study Start Date : 2020-07-20
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria for Participants
  • * Age 65 and older;
  • * At least one office visit to their primary care physician within the previous 12 months;
  • * Use of a target anticholinergic medication within the last two weeks OR medical record evidence of exposure to target anticholinergic medications at or above a cognitive risk threshold in the prior 12 months
  • * Able to communicate in English;
  • * Access to a telephone
Exclusion Criteria for Participants
  • * Permanent resident of an extended care facility (nursing home)
  • * Diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder defined by International Classification of Diseases (ICD) version 9/10 codes
  • * Diagnosis of Alzheimer's Disease or Related Dementia as determined by (a), (b), or (c) below
    • 1. ICD-9/10 codes, or
    • 2. Current use of a medication for Alzheimer's Disease or a Related Dementia, or
    • 3. A pattern of responses to the Functional Activities Questionnaire (FAQ) that indicate dementia (i.e., ≥ 3 FAQ items are scored at "requires assistance," or if ≥ 1 FAQ item is scored at "dependent").
Reducing Risk of Dementia Through Deprescribing

Location Details

NCT04270474

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Indiana

Eskenazi Eealiti

Indianapolis, Indiana, United States, 46202

ACTIVE NOT RECRUITING

United States, Indiana

Indiana University Health

Indianapolis, Indiana, United States, 46202

RECRUITING

United States, Indiana

Community Health Network Foundation, Inc.

Indianapolis, Indiana, United States, 46256