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

Dementia Clinical Trial

— AMOR-KY  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05078437
• Other study ID #: 69305
• Secondary ID: R24AG064025
• Status: Terminated
• Phase: N/A
• Start date: October 14, 2021
• Est. completion date: May 14, 2023

Study information

• Verified date: July 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: May 14, 2023
• Est. primary completion date: May 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
Daniela Moga	National Institute on Aging (NIA), Northern California Institute of Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in medication use	Medication Appropriateness Index (MAI) and change in number of medications (total number and number of PIM)will be measured as change from baseline.	3 months and 6 months
Primary	Participant satisfaction	Patients and caregivers will be asked to provide feedback on participation in the deprescribing process.	6 months
Primary	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.	3 months and 6 months
Secondary	Deprescribing assessments	The revised Patients Attitudes towards deprescribing (rPATD) will assess attitudes towards deprescribing	6 months
Secondary	Caregiver assessment	The appraisal of self-care will be used to asses additional outcomes in caregiver	6 months
Secondary	Cognitive function	The investigators will use the cognitive battery that is incorporated in the telemedicine assessments to explore the impact of the intervention on cognitive function.	6 months