NCT02172612

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2015

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

June 20, 2014

Last Update Submit

March 27, 2019

Conditions

Alzheimer Disease

Keywords

Anticholinergic drugs

Outcome Measures

Primary Outcomes (1)

  • Change in appropriateness of anticholinergic medication prescribing practices.

    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)

    Two years

Secondary Outcomes (1)

  • Change in Anticholinergic Burden

    2 years

Other Outcomes (1)

  • Change in perceived health status

    2 years

Study Arms (2)

Arm 1 - Intervention

EXPERIMENTAL

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

Arm 2 - Control

NO INTERVENTION

Those included in the control group will receive a generic brochure about medication safety and inappropriate medication use in the elderly.

Interventions

Arm 1 Education SessionOTHER

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.

Arm 1 - Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Are younger than 65 years of age
  • Have moderate to severe cognitive impairment
  • Live in a long-term care facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sander's BrownCenter on Aging

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

  • Moga DC, Abner EL, Rigsby DN, Eckmann L, Huffmyer M, Murphy RR, Coy BB, Jicha GA. Optimizing medication appropriateness in older adults: a randomized clinical interventional trial to decrease anticholinergic burden. Alzheimers Res Ther. 2017 May 23;9(1):36. doi: 10.1186/s13195-017-0263-9.

    PMID: 28535785DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Daniela C Moga, MD, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 20, 2014

First Posted

June 24, 2014

Study Start

September 1, 2014

Primary Completion

November 20, 2015

Study Completion

November 20, 2015

Last Updated

March 29, 2019

Record last verified: 2019-03

Locations

US(1)