Trial Outcomes & Findings for Medication Adherence With Polyglot Meducation (NCT NCT01744392)

NCT ID: NCT01744392

Last Updated: 2015-11-24

Results Overview

Medication Possession Ratio (MPR) is defined as the number of daily doses of medication dispensed by the pharmacy to each patient, divided by the patient's total follow-up time." The time period for the assessment for baseline MPR 12 months prior to enrollment.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: baseline
• Results posted on: 2015-11-24

Participant Flow

Participant milestones

Measure	Education Intervention The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
Overall Study STARTED	23
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Education Intervention The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.

Overall Study Physician Decision

1

Baseline Characteristics

Medication Adherence With Polyglot Meducation

Baseline characteristics by cohort

Measure	Education Intervention n=23 Participants The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
Age, Continuous	66.6 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	9 participants n=5 Participants
Race/Ethnicity, Customized African American	14 participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants
Health Literacy Low Health Literacy	9 participants n=5 Participants
Health Literacy High Health Literacy	14 participants n=5 Participants
Employed (full or part-time) Employed	7 participants n=5 Participants
Employed (full or part-time) Not Employed	16 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

Medication Possession Ratio (MPR) is defined as the number of daily doses of medication dispensed by the pharmacy to each patient, divided by the patient's total follow-up time." The time period for the assessment for baseline MPR 12 months prior to enrollment.

Outcome measures

Measure

Education Intervention n=23 Participants The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.

Medication Possession Ratio at Baseline

65.0 percentage of medication possession Standard Deviation 1.14

PRIMARY outcome

Timeframe: 6 months

Medication Possession Ratio (MPR) is defined as the number of daily doses of medication dispensed by the pharmacy to each patient, divided by the patient's total follow-up time." The time period for the assessment for 6 months MPR 6 months after enrollment.

Outcome measures

Measure

Education Intervention n=23 Participants The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.

Medication Possession Ratio at 6 Months

68.2 percentage of medication possession Standard Deviation 0.28

SECONDARY outcome

Timeframe: baseline

Clinical Characteristics at Baseline for Systolic & Diastolic Blood Pressure,

Outcome measures

Measure	Education Intervention n=23 Participants The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
Blood Pressure at Baseline Systolic Blood Pressure	130.06 mmHg Standard Deviation 15.1
Blood Pressure at Baseline Diastolic Blood Pressure	76.6 mmHg Standard Deviation 8.0

SECONDARY outcome

Timeframe: 6 months

Clinical Characteristics at 6 months for Systolic & Diastolic Blood Pressure,

Outcome measures

Measure	Education Intervention n=23 Participants The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
Blood Pressure at 6 Months Diastolic Blood Pressure	75.1 mmHg Standard Deviation 10.4
Blood Pressure at 6 Months Systolic Blood Pressure	130.1 mmHg Standard Deviation 18.4

SECONDARY outcome

Timeframe: baseline

Clinical Characteristics at Baseline for LDL, HDL,Total Cholesterol and Creatinine

Outcome measures

Measure	Education Intervention n=23 Participants The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
Cholesterol & Creatinine Levels at Baseline LDL Cholesterol	77.0 mg/dL Standard Deviation 17.4
Cholesterol & Creatinine Levels at Baseline HDL Cholesterol	45.1 mg/dL Standard Deviation 19.5
Cholesterol & Creatinine Levels at Baseline Total Cholesterol	152.4 mg/dL Standard Deviation 41.4
Cholesterol & Creatinine Levels at Baseline Creatinine	1.1 mg/dL Standard Deviation 0.2

SECONDARY outcome

Timeframe: 6 months

Clinical Characteristics at 6 months for LDL, HDL,Total Cholesterol and Creatinine

Outcome measures

Measure	Education Intervention n=23 Participants The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
Cholesterol & Creatinine Levels at 6 Months LDL Cholesterol	82.3 mg/dL Standard Deviation 16.9
Cholesterol & Creatinine Levels at 6 Months HDL Cholesterol	46.4 mg/dL Standard Deviation 26.1
Cholesterol & Creatinine Levels at 6 Months Total Cholesterol	160.0 mg/dL Standard Deviation 41.7
Cholesterol & Creatinine Levels at 6 Months Creatinine	1.2 mg/dL Standard Deviation 0.3

SECONDARY outcome

Timeframe: baseline

Clinical Characteristics at Baseline for Weight

Outcome measures

Measure

Education Intervention n=23 Participants The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.

Weight at Baseline

223.0 pounds Standard Deviation 2.9

SECONDARY outcome

Timeframe: 6 months

Clinical Characteristics at 6 months for Weight

Outcome measures

Measure

Education Intervention n=23 Participants The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.

Weight at 6 Months

219.4 pounds Standard Deviation 48.9

SECONDARY outcome

Timeframe: baseline

Clinical Characteristics at Baseline for Pulse

Outcome measures

Measure

Education Intervention n=23 Participants The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.

Pulse at Baseline

73.2 beats per minute Standard Deviation 20.9

SECONDARY outcome

Timeframe: 6 months

Clinical Characteristics at 6 month for Pulse

Outcome measures

Measure

Education Intervention n=23 Participants The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.

Pulse at 6 Months

70.3 beats per minute Standard Deviation 14.0

Adverse Events

Education Intervention

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Education Intervention n=23 participants at risk The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
Infections and infestations Infections	13.0% 3/23 • Number of events 3 • From enrollment through study completion (6 months)
Injury, poisoning and procedural complications ER visit	4.3% 1/23 • Number of events 1 • From enrollment through study completion (6 months)
Vascular disorders Vascular Event	8.7% 2/23 • Number of events 2 • From enrollment through study completion (6 months)
Psychiatric disorders ER visit	4.3% 1/23 • Number of events 2 • From enrollment through study completion (6 months)
Respiratory, thoracic and mediastinal disorders ER visit	8.7% 2/23 • Number of events 3 • From enrollment through study completion (6 months)
General disorders ER visit	13.0% 3/23 • Number of events 3 • From enrollment through study completion (6 months)
Cardiac disorders Hospitalization	8.7% 2/23 • Number of events 2 • From enrollment through study completion (6 months)
Musculoskeletal and connective tissue disorders ER visit	13.0% 3/23 • Number of events 3 • From enrollment through study completion (6 months)
Gastrointestinal disorders ER	8.7% 2/23 • Number of events 2 • From enrollment through study completion (6 months)
Renal and urinary disorders Hospitalization	4.3% 1/23 • Number of events 1 • From enrollment through study completion (6 months)
Endocrine disorders ER Visit	4.3% 1/23 • Number of events 1 • From enrollment through study completion (6 months)
Nervous system disorders Hospitalization	4.3% 1/23 • Number of events 2 • From enrollment through study completion (6 months)

Other adverse events

Adverse event data not reported

Additional Information

Hayden B. Bosworth, PhD

Health Services Research & Development, Durham VAMC

Phone: 919-286-0411

Email: hayden.bosworth@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place