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Reducing Risk of Dementia Through Deprescribing (R2D2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04270474
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Noll Campbell, Indiana University

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 Intervention/treatment Phase
Dementia Alzheimer Disease, Late Onset Other: Deprescribing of target anticholinergics Other: Usual Care Not Applicable

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. 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 target population will be primary care older adults with subjective cognitive decline or make at least one error on a cognitive screening test, but do not have dementia, and are currently using a strong anticholinergic medication. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This cluster-randomized trial will randomize at the level of physicians. Physicians agreeing to participate in the trial will be randomized to intervention or usual care in blocks of two or four. Physician randomization status will determine participants' study group. Physicians randomized to usual care will not have access to the intervention.
Masking: Double (Investigator, Outcomes Assessor)
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 : July 15, 2020
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Active Intervention (ACT)
Pharmacist-based Deprescribing
Other: Deprescribing of target anticholinergics
The active intervention group (ACT) will receive a pharmacist-based deprescribing intervention focused only on targeted anticholinergic medications. The intervention pharmacist will serve as the central source of communication between participants, providers, and (as needed) dispensing pharmacy to coordinate the deprescribing process. The study pharmacists will navigate a shared-decision model between the physicians and participant in order to personalize the selection of appropriate alternatives and switch/titration schedules. Importantly, the pharmacist will supervise the titration and deprescribing plan and communicate with both participants and physicians throughout the study.

Sham Comparator: Usual Care (UC)
Usual Care
Other: Usual Care
Those in the usual care group will not have access to the study intervention, but will receive a one-time information packet through the mail reviewing risks of polypharmacy, but no information specific to anticholinergic medications. They will receive clinical care as usually provided by their primary care or specialty care physicians.




Primary Outcome Measures :
  1. Change in Cognitive Composite Score [ Time Frame: Baseline, 6, 12, 18, and 24 months ]
    Cognitive composite scores will be collected at baseline, 6, 12, 18 and 24 months and changes in the composite scores over time will be compared between the intervention and usual care groups. An overall cognitive composite score including measures of information processing speed, memory, and executive function will be conducted at each time point from the average of each measure's z-score, constructed by subtracting the mean baseline scores and dividing by the baseline standard deviation. The z-score transformation of the cognitive composite score will have a mean of 0 and standard deviation of 1 at baseline, with higher scores representing improvement in cognition.

  2. Change in Patient Reported Outcome Measurement Information System (PROMIS) [ Time Frame: Baseline, 6, 12, 18, and 24 months ]
    Self-reported, 4-item scales evaluating depression, anxiety, pain, and insomnia will be collected for each participant at each time point. Each PROMIS measure raw score can be converted to a T-score where 50 represents the general population norm for that symptom and each 10-point deviation represents one standard deviation (SD) from the population norm. Changes in the T-scores over time will be compared between the intervention and usual care groups.

  3. Change in Health Utilities Index (HUI) [ Time Frame: Baseline, 6, 12, 18, and 24 months ]
    Self-reported measure of health-related quality of life, evaluating domains including vision, hearing, speech, ambulation, dexterity, emotion, cognitive function and pain. These attributes produce a single score on a standardized utility measure with individual health domain scores ranging from 0.00 (maximum impairment) to 1.00 (no impairment) and the multi-attribute (HUI) scores ranging from 0.36 to 1.00 with anchors 0.00 = dead and 1.00 = perfect health. HUI scores will be collected at each outcome assessment and change in HUI scores over time will be compared between the intervention and usual care groups.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 65 and older;
  • At least one office visit to their primary care physician within the previous 12 months;
  • At least one strong anticholinergic medication taken in the previous 2 weeks
  • Subjective cognitive dysfunction defined by meeting either (a) or (b) of the following criteria:

    1. A response of "somewhat worse" or "much worse" to the screening question: "In general, how would you describe your memory as compared to 10 years ago? Response offerings are: much better / somewhat better / about the same / somewhat worse / much worse.
    2. A score of 5 or less on the Six-Item Screener (SIS).
  • Able to communicate in English;
  • Access to a telephone

Exclusion Criteria:

  • 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").

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): NCT04270474


Contacts
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Contact: Noll L Campbell, PharmD, MS (317)274-9051 campbenl@iu.edu

Locations
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United States, Indiana
Eskenazi Health Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Noll L Campbell, PharmD, MS    317-274-9051    campbenl@iu.edu   
Principal Investigator: Noll L Campbell, PharmD, MS         
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Noll L Campbell, PharmD, MS    317-274-9051    campbenl@iu.edu   
Principal Investigator: Noll L Campbell, PharmD, MS         
Sponsors and Collaborators
Indiana University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Noll L Campbell, PharmD, MS Indiana University/Purdue University
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Responsible Party: Noll Campbell, Adjunct Assistant Professor, Indiana University
ClinicalTrials.gov Identifier: NCT04270474    
Other Study ID Numbers: 1706800075
R01AG061452 ( U.S. NIH Grant/Contract )
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data collected through this trial will be made available to either advance scientific research in a way that is allowed by the federal regulations that protect research subjects, or for the purpose of auditing or program evaluation by the government or funding agency. Data sharing for scientific purposes is essential for further translation of research results into knowledge, products, and procedures to improve human health. To protect participants' rights and confidentiality, protected health information will be limited to the minimum necessary for authorized oversight before the data are shared.The final dataset will include demographic, clinical, and limited genetic data. The final subject-level, de-identified dataset will be made available to qualified individuals within the scientific community.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: The final data set will be made available no later than 9 months of the database lock or at the time of on-line publication of the primary results, whichever comes first.
Access Criteria: We anticipated access to the study data will be facilitated in collaboration with the Global Alzheimer's Association Interactive Network (GAAIN). As a GAAIN Data Partner, data from this study will be shared in aggregate through the GAAIN portal (gaain.org). GAAIN provides a global infrastructure for cooperative research by linking data repositories that have collected information from participants who are at risk for or have been diagnosed with Alzheimer's disease. The GAAIN network allows the investigator to retain ownership of the data collected in each study, and can detach the data at any time. Only de-identified data is shared with GAAIN or any other research entity.

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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 Noll Campbell, Indiana University:
deprescribing
anticholinergics
dementia
cognition
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Late Onset Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs