Assessment of Medication Optimization in Rural Kentucky Appalachian Patients With Mild Cognitive Impairment or Dementia (AMOR-KY)

Assessment of Medication Optimization in Rural Kentucky Appalachian Patients With Mild Cognitive Impairment or Dementia: The AMOR Kentucky Study

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.

Study Overview

• Status: Terminated
• Conditions: Dementia; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Medication therapy management

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0596
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in the Medication Appropriateness Index	The Medication Appropriateness Index (MAI) is a score based on 10 criteria used to assess the appropriateness of each medication taken by a study participant. Medications are rated as "appropriate", "marginally appropriate", or "inappropriate" based on these ten criteria. Each medication was scored between 0 (appropriate) and the maximum of 18 (inappropriate for all criteria), then the total MAI was obtained by adding the medication specific MAIs for all medications reported by the participant. For each participant, the total MAI is calculated as the sum of the score for all the medications taken by that participant. The minimum is 0 (all medications are appropriate), but there is no maximum because that depends on the number of medications. A decrease in MAI indicates improvement in medication appropriateness.	Baseline and 3 months
Participant Satisfaction	Patients will be asked to provide feedback on participation in the deprescribing process.	6 months
Connectivity Issues	Participants will be asked to report on any connectivity issues that would impact the appropriate delivery of the intervention using the telemedicine approach. Number of participants that experienced any connectivity issues.	3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deprescribing Assessments	The revised Patients Attitudes towards deprescribing (rPATD) will assess attitudes towards deprescribing	6 months
Caregiver Assessment- Zarit	The appraisal of self-care will be used to asses additional outcomes in caregiver. Zarit Burden Interview includes 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden. A score of 17 or more was considered high burden.	6 months
Cognitive Function- CDR Global Score	The investigators will use the cognitive battery that is incorporated in the telemedicine assessments to explore the impact of the intervention on cognitive function. Clinical Dementia Rating (CDR) Global Score 0: Normal (unimpaired) cognition; 0.5: MCI due to AD; 1: Mild AD dementia; 2: Moderate AD dementia; 3: Severe AD dementia	6 months

Collaborators and Investigators

• Sponsor: Daniela Moga
• Collaborators: National Institute on Aging (NIA); Northern California Institute of Research and Education

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Actual): May 14, 2023
• Study Completion (Actual): May 14, 2023

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: dementia; Alzheimer's disease; telemedicine; medication optimization; rural population
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Dementia; Cognitive Dysfunction
• Other Study ID Numbers: 69305; R24AG064025 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This trial will be registered with clinicaltrials.gov and all raw data, stripped of identifiers, will be made available to interested parties and researchers with submission of written request to the study PI not sooner than one year after acceptance and publication of the primary manuscript. There will be no charge for release of the dataset.
• IPD Sharing Time Frame: not sooner than one year after acceptance and publication of the primary manuscript
• IPD Sharing Access Criteria: request submitted to the study PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No