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Clinical Trials/NCT05078437
NCT05078437TerminatedNot Applicable

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

Daniela Moga2 sites in 1 country16 target enrollmentStarted: October 14, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
16
Locations
2
Primary Endpoint
Connectivity Issues

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Connectivity Issues

Time Frame: 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. Number of participants that experienced any connectivity issues.

Mean Change From Baseline in the Medication Appropriateness Index

Time Frame: Baseline and 3 months

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.

Participant Satisfaction

Time Frame: 6 months

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

Secondary Outcomes

  • Caregiver Assessment- Zarit(6 months)
  • Deprescribing Assessments(6 months)
  • Cognitive Function- CDR Global Score(6 months)

Investigators

Sponsor
Daniela Moga
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Daniela Moga

Associate Professor

University of Kentucky

Study Sites (2)

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