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Trial record 5 of 32 for:    University of Kentucky | Alzheimer's disease | United States, Kentucky

A Pilot Study to Reduce Inappropriate Anticholinergic Prescribing in the Elderly

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Daniela Moga, University of Kentucky
ClinicalTrials.gov Identifier:
NCT02172612
First received: June 20, 2014
Last updated: March 7, 2017
Last verified: March 2017
  Purpose
This will be an eight-week, prospective, placebo-controlled, randomized trial to evaluate a patient-centered team (pharmacist-physician) intervention to improve medication appropriateness and reduce the use of inappropriate anticholinergic medications in elderly patients enrolled in the Sanders-Brown Alzheimer's Disease Center (ADC) cohort.

Condition Intervention
Alzheimer Disease Other: Arm 1 Education Session

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Patient-Centered Medication Therapy Management Intervention to Reduce Inappropriate Anticholinergic Prescribing in the Elderly

Resource links provided by NLM:


Further study details as provided by Daniela Moga, University of Kentucky:

Primary Outcome Measures:
  • Change in appropriateness of anticholinergic medication prescribing practices. [ Time Frame: Two years ]
    This will be measured through the change in the appropriateness of anticholinergic medication prescribing from baseline to follow-up, as measured by the medication appropriateness index (MAI)


Secondary Outcome Measures:
  • Change in Anticholinergic Burden [ Time Frame: 2 years ]
    The anticholinergic burden will be measured from baseline to follow-up, as measured by the anticholinergic drug scale (ADS).Anticholinergic burden (and change from baseline to follow-up) will be measure using the updated ADS score; the ADS has four levels for each included drug, ranging from 0 (no known anticholinergic activity) to 3 (markedly anticholinergic activity). The summation of anticholinergic activity level for all the drugs taken by a patient reflects the total anticholinergic burden.


Other Outcome Measures:
  • Change in perceived health status [ Time Frame: 2 years ]
    Will be measured using the SF-36 at baseline and at the Week 8, End-of-study visit.


Estimated Enrollment: 50
Study Start Date: September 2014
Estimated Study Completion Date: December 31, 2018
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 - Intervention
Those included in the intervention group will undergo an educational session with the study pharmacist and one of the licensed prescribers from Sanders-Brown to discuss recommended changes in their treatment plan. If changes in medications are indicated by the pharmacist-prescriber team, and accepted by the patient, new prescriptions will be provided and a letter will be sent to the primary care physicians detailing the changes made and the rationale behind such changes.
Other: Arm 1 Education Session
Those included in the intervention group will undergo an educational session with the study pharmacist and one of the licensed prescribers from Sanders-Brown to discuss recommended changes in their treatment plan. If changes in medications are indicated by the pharmacist-prescriber team, and accepted by the patient, new prescriptions will be provided and a letter will be sent to the primary care physicians detailing the changes made and the rationale behind such changes.
No Intervention: Arm 2 - Control
Those included in the control group will receive a generic brochure about medication safety and inappropriate medication use in the elderly.

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Enrolled at the Sander's Brown Center on Aging Alzheimer Disease Center
  • Are 65 years of age or older
  • Are taking at least one anticholinergic medication
  • No cognitive impairment or mild cognitive impairment

Exclusion Criteria:

  • Are younger than 65 years of age
  • Have moderate to severe cognitive impairment
  • Live in a long-term care facility
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02172612

Locations
United States, Kentucky
Sander's BrownCenter on Aging
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Daniela Moga
Investigators
Principal Investigator: Daniela C Moga, MD, PhD University of Kentucky
  More Information

Responsible Party: Daniela Moga, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT02172612     History of Changes
Other Study ID Numbers: 14-0461-F3R
Study First Received: June 20, 2014
Last Updated: March 7, 2017

Keywords provided by Daniela Moga, University of Kentucky:
Anticholinergic drugs

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dementia
Tauopathies
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017