Clinical trial NCT05078437: Assessment of Medication Optimization in Rural Kentucky Appalachian Patients With Mild Cognitive Impairment or Dementia
Official title: Assessment of Medication Optimization in Rural Kentucky Appalachian Patients With Mild Cognitive Impairment or Dementia: The AMOR Kentucky Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dementia
Mild Cognitive Impairment
Keywords: medication optimization
rural population
dementia
Alzheimer's disease
telemedicine
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Northern California Institute of Research and Education
First posted: 2021-10-14
Enrollment: 16
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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)

Primary outcomes:
measure: Mean Change From Baseline in the Medication Appropriateness Index
timeFrame: Baseline and 3 months
measure: Participant Satisfaction
timeFrame: 6 months
measure: Connectivity Issues
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Deprescribing Assessments
timeFrame: 6 months
measure: Caregiver Assessment- Zarit
timeFrame: 6 months
measure: Cognitive Function- CDR Global Score
timeFrame: 6 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References: