Dementia, Mild Cognitive Impairment
Conditions
Keywords
medication optimization, rural population, dementia, Alzheimer's disease, telemedicine
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.
Interventions
BEHAVIORALMedication 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.
Sponsors
National Institute on Aging (NIA)
Northern California Institute of Research and Education
Daniela Moga
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the Medication Appropriateness Index | Baseline and 3 months | 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. |
| Participant Satisfaction | 6 months | Patients will be asked to provide feedback on participation in the deprescribing process. |
| Connectivity Issues | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Deprescribing Assessments | 6 months | The revised Patients Attitudes towards deprescribing (rPATD) will assess attitudes towards deprescribing |
| Caregiver Assessment- Zarit | 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. |
| Cognitive Function- CDR Global Score | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Treatment Optimization |
|---|---|
| Age, Continuous | 77 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 16 |
| other Total, other adverse events | 12 / 16 |
| serious Total, serious adverse events | 1 / 16 |
Outcome results
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. Number of participants that experienced any connectivity issues.
Time frame: 3 months and 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Connectivity Issues | 6 Participants |
Primary
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Mean Change From Baseline in the Medication Appropriateness Index | -5.8 units on a scale | Standard Error 6.3 |
Primary
Participant Satisfaction
Patients will be asked to provide feedback on participation in the deprescribing process.
Time frame: 6 months
Population: Participants undergoing the MTM intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Participant Satisfaction | Strongly Agree or Agree | 10 Participants |
| Intervention | Participant Satisfaction | Neutral | 3 Participants |
Secondary
Caregiver Assessment- Zarit
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Caregiver Assessment- Zarit | 1.3 units on a scale | Standard Deviation 6.6 |
Secondary
Cognitive Function- CDR Global Score
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Cognitive Function- CDR Global Score | 0.2 score on a scale | Standard Deviation 0.4 |
Secondary
Deprescribing Assessments
The revised Patients Attitudes towards deprescribing (rPATD) will assess attitudes towards deprescribing
Time frame: 6 months
Population: Participants undergoing the MTM intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Deprescribing Assessments | Yes or maybe | 11 Participants |
| Intervention | Deprescribing Assessments | No | 3 Participants |