Assessment of Medication Optimization in Rural Kentucky Appalachian Patients With Mild Cognitive Impairment or Dementia (AMOR-KY)
Primary Purpose
Dementia, Mild Cognitive Impairment
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medication therapy management
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring medication optimization, rural population, dementia, Alzheimer's disease, telemedicine
Eligibility Criteria
- 60 years or older,
- diagnosed with mild cognitive impairment or dementia,
- using at least one potentially inappropriate medications,
- living in the community,
- willing to participate in the study (both the patient and the caregiver)
Sites / Locations
- University of Kentucky
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment optimization
Arm Description
Participants will undergo an evaluation of all the medications taken and changes will be proposed for treatment optimization.
Outcomes
Primary Outcome Measures
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.
Participant satisfaction
Patients and caregivers will be asked to provide feedback on participation in the deprescribing process.
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.
Secondary Outcome Measures
Deprescribing assessments
The revised Patients Attitudes towards deprescribing (rPATD) will assess attitudes towards deprescribing
Caregiver assessment
The appraisal of self-care will be used to asses additional outcomes in caregiver
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.
Full Information
NCT ID
NCT05078437
First Posted
September 20, 2021
Last Updated
July 12, 2023
Sponsor
Daniela Moga
Collaborators
National Institute on Aging (NIA), Northern California Institute of Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT05078437
Brief Title
Assessment of Medication Optimization in Rural Kentucky Appalachian Patients With Mild Cognitive Impairment or Dementia
Acronym
AMOR-KY
Official Title
Assessment of Medication Optimization in Rural Kentucky Appalachian Patients With Mild Cognitive Impairment or Dementia: The AMOR Kentucky Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Funding ended
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
May 14, 2023 (Actual)
Study Completion Date
May 14, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniela Moga
Collaborators
National Institute on Aging (NIA), Northern California Institute of Research and Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Mild Cognitive Impairment
Keywords
medication optimization, rural population, dementia, Alzheimer's disease, telemedicine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment optimization
Arm Type
Experimental
Arm Description
Participants will undergo an evaluation of all the medications taken and changes will be proposed for treatment optimization.
Intervention Type
Behavioral
Intervention Name(s)
Medication therapy management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in medication use
Description
Medication Appropriateness Index (MAI) and change in number of medications (total number and number of PIM)will be measured as change from baseline.
Time Frame
3 months and 6 months
Title
Participant satisfaction
Description
Patients and caregivers will be asked to provide feedback on participation in the deprescribing process.
Time Frame
6 months
Title
Connectivity issues
Description
Participants will be asked to report on any connectivity issues that would impact the appropriate delivery of the intervention using the telemedicine approach.
Time Frame
3 months and 6 months
Secondary Outcome Measure Information:
Title
Deprescribing assessments
Description
The revised Patients Attitudes towards deprescribing (rPATD) will assess attitudes towards deprescribing
Time Frame
6 months
Title
Caregiver assessment
Description
The appraisal of self-care will be used to asses additional outcomes in caregiver
Time Frame
6 months
Title
Cognitive function
Description
The investigators will use the cognitive battery that is incorporated in the telemedicine assessments to explore the impact of the intervention on cognitive function.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
60 years or older,
diagnosed with mild cognitive impairment or dementia,
using at least one potentially inappropriate medications,
living in the community,
willing to participate in the study (both the patient and the caregiver)
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0596
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
This trial will be registered with clinicaltrials.gov and all raw data, stripped of identifiers, will be made available to interested parties and researchers with submission of written request to the study PI not sooner than one year after acceptance and publication of the primary manuscript. There will be no charge for release of the dataset.
IPD Sharing Time Frame
not sooner than one year after acceptance and publication of the primary manuscript
IPD Sharing Access Criteria
request submitted to the study PI
Learn more about this trial
Assessment of Medication Optimization in Rural Kentucky Appalachian Patients With Mild Cognitive Impairment or Dementia
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