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

NCT05078437 | Terminated Results

• 2 other identifiers: 69305R24AG064025
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Mild Cognitive Impairment

Keywords

medication optimization; rural population; dementia; Alzheimer's disease; telemedicine

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Deprescribing Assessments

  6 months

• Caregiver Assessment- Zarit

  6 months

• Cognitive Function- CDR Global Score

  6 months

Study Arms (1)

Treatment optimization

EXPERIMENTAL

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

Behavioral: Medication therapy management

Interventions

Medication therapy management BEHAVIORAL

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.

Treatment optimization

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536-0596, United States

Location

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Alzheimer Disease

Interventions

Medication Therapy Management

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Daniela Moga, Associate Professor
• Organization: University of Kentucky

daniela.moga@uky.edu

8593239682

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 14, 2021
• Study Start: October 14, 2021
• Primary Completion: May 14, 2023
• Study Completion: May 14, 2023
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: not sooner than one year after acceptance and publication of the primary manuscript
• Access Criteria: request submitted to the study PI

Locations

US (1)