Trial Outcomes & Findings for Assessment of Medication Optimization in Rural Kentucky Appalachian Patients With Mild Cognitive Impairment or Dementia (NCT NCT05078437)

Last Updated: 2024-08-23

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2024-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Optimization Participants will undergo an evaluation of all the medications taken and changes will be proposed for treatment optimization. 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.
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Optimization n=16 Participants Participants will undergo an evaluation of all the medications taken and changes will be proposed for treatment optimization. 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.
Age, Continuous	77 years n=99 Participants
Sex: Female, Male Female	10 Participants n=99 Participants
Sex: Female, Male Male	6 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	16 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	16 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: For each participant, a change score was calculated based on the MAI at EOS and at baseline. A negative number indicates improvement in appropriateness. The change MAI score is averaged among participants.

Outcome measures

Outcome measures
Measure	Intervention n=12 Participants Participants undergoing the MTM intervention
Mean Change From Baseline in the Medication Appropriateness Index	-5.8 units on a scale Standard Error 6.3

PRIMARY outcome

Timeframe: 6 months

Population: Participants undergoing the MTM intervention

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

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants Participants undergoing the MTM intervention
Participant Satisfaction Strongly Agree or Agree	10 Participants
Participant Satisfaction Neutral	3 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=16 Participants Participants undergoing the MTM intervention
Connectivity Issues	6 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants undergoing the MTM intervention

The revised Patients Attitudes towards deprescribing (rPATD) will assess attitudes towards deprescribing

Outcome measures

Outcome measures
Measure	Intervention n=14 Participants Participants undergoing the MTM intervention
Deprescribing Assessments Yes or maybe	11 Participants
Deprescribing Assessments No	3 Participants

SECONDARY outcome

Timeframe: 6 months

The appraisal of self-care will be used to asses additional outcomes in caregiver. Zarit Burden Interview includes 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden. A score of 17 or more was considered high burden.

Outcome measures

Outcome measures
Measure	Intervention n=15 Participants Participants undergoing the MTM intervention
Caregiver Assessment- Zarit	1.3 units on a scale Standard Deviation 6.6

SECONDARY outcome

Timeframe: 6 months

The investigators will use the cognitive battery that is incorporated in the telemedicine assessments to explore the impact of the intervention on cognitive function. Clinical Dementia Rating (CDR) Global Score 0: Normal (unimpaired) cognition; 0.5: MCI due to AD; 1: Mild AD dementia; 2: Moderate AD dementia; 3: Severe AD dementia

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants Participants undergoing the MTM intervention
Cognitive Function- CDR Global Score	0.2 score on a scale Standard Deviation 0.4

Adverse Events

Treatment Optimization

Serious events: 1 serious events

Other events: 12 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Optimization n=16 participants at risk Participants will undergo an evaluation of all the medications taken and changes will be proposed for treatment optimization. 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.
Infections and infestations Infection or febrile neutropenia	6.2% 1/16 • Number of events 1 • 6 months Information was collected using clinicaltrials.gov definitions during study visit via telehealth

Other adverse events

Other adverse events
Measure	Treatment Optimization n=16 participants at risk Participants will undergo an evaluation of all the medications taken and changes will be proposed for treatment optimization. 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.
General disorders allergy/immunology	12.5% 2/16 • Number of events 2 • 6 months Information was collected using clinicaltrials.gov definitions during study visit via telehealth
Gastrointestinal disorders gastrointestinal	12.5% 2/16 • Number of events 2 • 6 months Information was collected using clinicaltrials.gov definitions during study visit via telehealth
Infections and infestations infection or febrile neutropenia	6.2% 1/16 • Number of events 1 • 6 months Information was collected using clinicaltrials.gov definitions during study visit via telehealth
Metabolism and nutrition disorders metabolic/laboratory	12.5% 2/16 • Number of events 2 • 6 months Information was collected using clinicaltrials.gov definitions during study visit via telehealth
Musculoskeletal and connective tissue disorders musculoskeletal	18.8% 3/16 • Number of events 3 • 6 months Information was collected using clinicaltrials.gov definitions during study visit via telehealth
Nervous system disorders neurology	31.2% 5/16 • Number of events 6 • 6 months Information was collected using clinicaltrials.gov definitions during study visit via telehealth
General disorders pain	6.2% 1/16 • Number of events 1 • 6 months Information was collected using clinicaltrials.gov definitions during study visit via telehealth
Renal and urinary disorders renal/genitourinary	6.2% 1/16 • Number of events 1 • 6 months Information was collected using clinicaltrials.gov definitions during study visit via telehealth

Additional Information

Daniela Moga, Associate Professor

University of Kentucky

Phone: 8593239682

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place