Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R24AG064025 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Funding ended
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Northern California Institute of Research and Education | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment optimization | Experimental | Participants will undergo an evaluation of all the medications taken and changes will be proposed for treatment optimization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Deprescribing Assessments | The revised Patients Attitudes towards deprescribing (rPATD) will assess attitudes towards deprescribing | 6 months |
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536-0596 | United States |
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.
Not provided
not sooner than one year after acceptance and publication of the primary manuscript
request submitted to the study PI
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 3 months |
6 months
Information was collected using clinicaltrials.gov definitions during study visit via telehealth
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection or febrile neutropenia | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| allergy/immunology | General disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniela Moga, Associate Professor | University of Kentucky | 8593239682 | daniela.moga@uky.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2020 | Jun 12, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 31, 2022 | Jul 10, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D054539 | Medication Therapy Management |
| ID | Term |
|---|---|
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D054524 | Medicare Part D |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 6 months |
| 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 | 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Intervention | Participants undergoing the MTM intervention |
|
|
| Primary | Participant Satisfaction | Patients will be asked to provide feedback on participation in the deprescribing process. | Participants undergoing the MTM intervention | Posted | Count of Participants | Participants | 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. Number of participants that experienced any connectivity issues. | Posted | Count of Participants | Participants | 3 months and 6 months |
|
|
|
| Secondary | Deprescribing Assessments | The revised Patients Attitudes towards deprescribing (rPATD) will assess attitudes towards deprescribing | Participants undergoing the MTM intervention | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 1 |
| 16 |
| 1 |
| 16 |
| 12 |
| 16 |
| gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment |
|
| infection or febrile neutropenia | Infections and infestations | Non-systematic Assessment |
|
| metabolic/laboratory | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| neurology | Nervous system disorders | Non-systematic Assessment |
|
| pain | General disorders | Non-systematic Assessment |
|
| renal/genitourinary | Renal and urinary disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D007356 | Insurance, Pharmaceutical Services |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006278 | Medicare |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |