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

• Sponsor: Daniela Moga (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05078437
• Collaborator: National Institute on Aging (NIA) (NIH), Northern California Institute of Research and Education (Other)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 20.5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia; Mild Cognitive Impairment	Behavioral: Medication therapy management	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Assessment of Medication Optimization in Rural Kentucky Appalachian Patients With Mild Cognitive Impairment or Dementia: The AMOR Kentucky Study
• Actual Study Start Date: Oct 14, 2021
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in medication use [3 months and 6 months]

   Medication Appropriateness Index (MAI) and change in number of medications (total number and number of PIM)will be measured as change from baseline.

2. Participant satisfaction [6 months]

   Patients and caregivers will be asked to provide feedback on participation in the deprescribing process.

3. Connectivity issues [3 months and 6 months]

   Participants will be asked to report on any connectivity issues that would impact the appropriate delivery of the intervention using the telemedicine approach.

Secondary Outcome Measures

1. Deprescribing assessments [6 months]

   The revised Patients Attitudes towards deprescribing (rPATD) will assess attitudes towards deprescribing

2. Caregiver assessment [6 months]

   The appraisal of self-care will be used to asses additional outcomes in caregiver

3. Cognitive function [6 months]

   The investigators will use the cognitive battery that is incorporated in the telemedicine assessments to explore the impact of the intervention on cognitive function.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40536-0596

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniela Moga, Associate Professor, University of Kentucky
• ClinicalTrials.gov Identifier: NCT05078437
• Other Study ID Numbers: 69305; R24AG064025
• First Posted: Oct 14, 2021
• Last Update Posted: Jun 27, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Daniela Moga, Associate Professor, University of Kentucky: medication optimization; rural population; dementia; Alzheimer's disease; telemedicine
• Additional relevant MeSH terms: Dementia; Cognitive Dysfunction

Study Results

No Results Posted as of Jun 27, 2022