Assessment of Medication Optimization in Rural Kentucky Appalachian Patients With Mild Cognitive Impairment or Dementia

NCT ID: NCT05078437

Last Updated: 2024-08-23

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-14

Study Completion Date

2023-05-14

Brief Summary

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The AMOR-Kentucky study will examine the impact of a pharmacist-physician patient-centered medication therapy management deprescribing intervention to address inappropriate medication use in patients with cognitive impairment in underserved, lower socioeconomic populations in rural Appalachian Kentucky. The results of this study will provide valuable insights on how to expand and implement deprescribing interventions using telemedicine to reduce the prevalence and the associated healthcare costs of medication-related problems in patients with mild cognitive impairment, Alzheimer's disease and other dementias in rural areas throughout the US. The investigators will assess the potential use of telemedicine in this population by performing an initial single arm, unblinded study of the medication therapy management (MTM) describing intervention in rural/underserved Kentucky Appalachian populations with cognitive impairment and/or dementia using potentially inappropriate medications (n=50). Following initial recruitment and clinical evaluation, engaged participants will have their medication list reviewed by a pharmacist-clinician team to identify targets for deprescribing intervention. The intervention will be engaged remotely with the participant and their caregiver, and the MTM team at 4 weeks post initial evaluation, and then reinforced at a 3-month timepoint. This approach will be carried forward through a telemedicine practice at University of Kentucky that is comprised of approximately 500 patient-caregiver dyads throughout rural areas of Appalachian Kentucky.

Detailed Description

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Conditions

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Dementia Mild Cognitive Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Treatment optimization

Participants will undergo an evaluation of all the medications taken and changes will be proposed for treatment optimization.

Group Type EXPERIMENTAL

Medication therapy management

Intervention Type BEHAVIORAL

The proposed deprescribing intervention is using a patient-centered framework by: (1) balancing the risks and benefits, and addressing the specific needs of each individual patient, (2) considering the individual patient and the caregiver's preferences and values, and (3) empowering the patient and the caregiver to take responsibility and fully participate in the decision-making process as equal team players.

Interventions

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Medication therapy management

The proposed deprescribing intervention is using a patient-centered framework by: (1) balancing the risks and benefits, and addressing the specific needs of each individual patient, (2) considering the individual patient and the caregiver's preferences and values, and (3) empowering the patient and the caregiver to take responsibility and fully participate in the decision-making process as equal team players.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. 60 years or older,
2. diagnosed with mild cognitive impairment or dementia,
3. using at least one potentially inappropriate medications,
4. living in the community,
5. willing to participate in the study (both the patient and the caregiver)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Northern California Institute of Research and Education

OTHER

Sponsor Role collaborator

Daniela Moga

OTHER

Sponsor Role lead

Responsible Party

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Daniela Moga

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R24AG064025

Identifier Type: NIH

Identifier Source: secondary_id

View Link

69305

Identifier Type: -

Identifier Source: org_study_id

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