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Medication Adherence With Polyglot Meducation

Evaluate Changes in Medication Adherence and Patient Perspective of Polyglot Systems, Inc's Meducation Technology

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01744392
Enrollment
23
Registered
2012-12-06
Start date
2013-02-28
Completion date
2014-07-31
Last updated
2015-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hypercholesterolemia, Hypertension

Brief summary

The investigators propose a 6 month pre-post, pilot,feasibility study with up to 25 individuals among veterans with cardiovascular disease risk factors including Hypertension (HT), Diabetes Mellitis (DM) and Hyperlipidemia (HL) who receive care from the hospital-based primary care clinics associated with Durham VAMC. The investigators will examine veteran's perception and ease of using an innovative tool to help improve medication adherence to cardiovascular medications. This study aims to focus on patients with multiple chronic conditions and their caregivers to address 1) appropriate use of medications 2)maximize patient self-care and care by families and other caregivers 3) make available a tool for medication management 4) managing complex regimens, and 5) addressing health literacy.

Detailed description

Recruitment letter: Each week, the research assistant (RA) will identify participants who have a medical appointment scheduled 3 weeks from the current date from the statistician's list of eligible participants. The RA will review Computerized Patient Record System (CPRS) to confirm enrollment at the Durham VA Medical Center (DVAMC) or Raleigh Community Based Outpatient Clinic (CBOC), identify participants' primary care provider and conduct a preliminary medical record review of the exclusion criteria listed above. An introductory recruitment letter signed by the patient's provider will be sent to these participants. Telephone Screening: The RA will call the participants between 1 and 2 weeks later to assess interest and eligibility using the telephone screening script. During this telephone call, the RA will ask permission to conduct the telephone screening to further evaluate the participants' eligibility to participate in the study. These screening questions are being asked because exclusion criteria may not be accurately reflected in the VA medical record. If participants agree to meet with study team to further discuss the project they will be scheduled for an interview. If requested, participant will be sent an appointment reminder letter signed by the study principal investigator and/or project coordinator. All participants will be sent reminder letters up to 3 weeks prior to their scheduled 3 and 6 month follow-up appointments. Consent Process: At this interview, the patient will be given greater detail about the study, and if agreeable, will provide written informed consent. Participants who consent to participate in the study and agree to be digitally audio recorded will also have complete form 10-3203 Consent for use of picture and /or voice at baseline. Interview Procedures: RAs will obtain the participants' outcome values (i.e., BP) from the clinical record at baseline, at 3 month follow-up. This information will be double-entered into an application on the Health Services Research & Development (HSRD) VA Server. At baseline and 3-month follow-up contacts, participants will also undergo an interview to determine secondary outcome variables including self-reported medication adherence and perceptions of the intervention. The baseline interview will be conducted in person if possible, however, at the 3 month follow-up appointment the interview will be conducted by telephone. The RA's will work with patients to be seen in a 6 week window around the original follow-up appointment. Pill refill will be calculated for all individuals at 6 months. Participant Contacts In-person meeting - Baseline After the consent process, at the baseline interview, a research assistant(RA) will conduct the outcome assessment procedures, which includes asking the participant questions about their age,race, medical history, self reported adherence to cardiovascular medications and their understanding about the risk of cardiovascular disease. The RA will also ask questions about their lifestyle, and quality of life. Participants who qualify for enrollment and provide informed consent will meet with the research pharmacist for education use of the Meducation Calendar. 3 month follow-up interview. A research assistant will contact participant via phone to determine secondary outcome variables including self reported medication adherence to cardiovascular medications. The entire interview should take no more than 30 minutes. Optional Qualitative: 3 month phone interview: For selected intervention participants only the RA will conduct a questionnaire about the participant's perception to determine which aspects of the Meducation Calendar intervention were most helpful for participants and which aspects need revision. Participants who agreed to the qualitative interview during the consent process will be asked during the 3 month interview to confirm their continued desire to participate in the audio recorded phone interview if selected. This visit should take no more than 30 minutes. Those selected to participate will be scheduled to complete the qualitative interview over the phone within 15 days from the time they complete the intervention and interview. The qualitative interview will be audio recorded digitally on a VA owned and configured computer and later transcribed using VA owned computer software. Names will not be associated with the audio recordings. After all recordings have been analyzed and coded, recordings will be destroyed in accordance with VA Information Security procedures. This phone call for the optional qualitative interview should take no more than 30 minutes.

Interventions

BEHAVIORALeducation 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.

Sponsors

Durham VA Medical Center
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Enrolled in one of three DVAMC Primary Care Clinics affiliated with the hospital for at least one year; * At least one visit to a primary care provider (PCP) at Durham VAMC associated primary care clinics in the previous 12 months; * Outpatient diagnostic code for hypertension (\> 140/90), diabetes and/or hypercholesterolemia * Prescription for metoprolol tartrate (twice a day beta blocker, most common 2 day medication prescribed in the VA) * Baseline Medication Possession Ratio (MPR) of \< 80% indicating medication non adherence * More than 9 active medications.

Exclusion criteria

* diagnosed with metastatic cancer, * diagnosed with dementia documented in medical record, * active diagnosis of psychosis documented in medical record with admission with last 30 days * participating in another clinical trial, * not currently receiving care at the Durham VAMC * resident of a nursing home, * hard time seeing type/printing on books, magazines articles, etc. * hard time hearing or speaking on the telephone * limited/no access to telephone * currently a patient in the primary care pharmacist medication management clinic at Durham VAMC * plans to move medical care from DVAMC in next 12 months

Design outcomes

Primary

MeasureTime frameDescription
Medication Possession Ratio at BaselinebaselineMedication 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.
Medication Possession Ratio at 6 Months6 monthsMedication 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.

Secondary

MeasureTime frameDescription
Cholesterol & Creatinine Levels at BaselinebaselineClinical Characteristics at Baseline for LDL, HDL,Total Cholesterol and Creatinine
Cholesterol & Creatinine Levels at 6 Months6 monthsClinical Characteristics at 6 months for LDL, HDL,Total Cholesterol and Creatinine
Weight at BaselinebaselineClinical Characteristics at Baseline for Weight
Blood Pressure at BaselinebaselineClinical Characteristics at Baseline for Systolic & Diastolic Blood Pressure,
Pulse at BaselinebaselineClinical Characteristics at Baseline for Pulse
Pulse at 6 Months6 monthsClinical Characteristics at 6 month for Pulse
Weight at 6 Months6 monthsClinical Characteristics at 6 months for Weight
Blood Pressure at 6 Months6 monthsClinical Characteristics at 6 months for Systolic & Diastolic Blood Pressure,

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
23
Total23

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyPhysician Decision1

Baseline characteristics

CharacteristicEducation Intervention
Age, Continuous66.6 years
STANDARD_DEVIATION 8.4
Employed (full or part-time)
Employed
7 participants
Employed (full or part-time)
Not Employed
16 participants
Health Literacy
High Health Literacy
14 participants
Health Literacy
Low Health Literacy
9 participants
Race/Ethnicity, Customized
African American
14 participants
Race/Ethnicity, Customized
Caucasian
9 participants
Region of Enrollment
United States
23 participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
21 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 23
serious
Total, serious adverse events
14 / 23

Outcome results

Primary

Medication Possession Ratio at 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.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Education InterventionMedication Possession Ratio at 6 Months68.2 percentage of medication possessionStandard Deviation 0.28
Comparison: Difference between percentages. Increases in value indicate improvement in adherence.p-value: 0.73t-test, 2 sided
Primary

Medication Possession Ratio at 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.

Time frame: baseline

ArmMeasureValue (MEAN)Dispersion
Education InterventionMedication Possession Ratio at Baseline65.0 percentage of medication possessionStandard Deviation 1.14
Secondary

Blood Pressure at 6 Months

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

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Education InterventionBlood Pressure at 6 MonthsSystolic Blood Pressure130.1 mmHgStandard Deviation 18.4
Education InterventionBlood Pressure at 6 MonthsDiastolic Blood Pressure75.1 mmHgStandard Deviation 10.4
Secondary

Blood Pressure at Baseline

Clinical Characteristics at Baseline for Systolic & Diastolic Blood Pressure,

Time frame: baseline

ArmMeasureGroupValue (MEAN)Dispersion
Education InterventionBlood Pressure at BaselineSystolic Blood Pressure130.06 mmHgStandard Deviation 15.1
Education InterventionBlood Pressure at BaselineDiastolic Blood Pressure76.6 mmHgStandard Deviation 8
Secondary

Cholesterol & Creatinine Levels at 6 Months

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

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Education InterventionCholesterol & Creatinine Levels at 6 MonthsLDL Cholesterol82.3 mg/dLStandard Deviation 16.9
Education InterventionCholesterol & Creatinine Levels at 6 MonthsHDL Cholesterol46.4 mg/dLStandard Deviation 26.1
Education InterventionCholesterol & Creatinine Levels at 6 MonthsTotal Cholesterol160.0 mg/dLStandard Deviation 41.7
Education InterventionCholesterol & Creatinine Levels at 6 MonthsCreatinine1.2 mg/dLStandard Deviation 0.3
Secondary

Cholesterol & Creatinine Levels at Baseline

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

Time frame: baseline

ArmMeasureGroupValue (MEAN)Dispersion
Education InterventionCholesterol & Creatinine Levels at BaselineCreatinine1.1 mg/dLStandard Deviation 0.2
Education InterventionCholesterol & Creatinine Levels at BaselineLDL Cholesterol77.0 mg/dLStandard Deviation 17.4
Education InterventionCholesterol & Creatinine Levels at BaselineHDL Cholesterol45.1 mg/dLStandard Deviation 19.5
Education InterventionCholesterol & Creatinine Levels at BaselineTotal Cholesterol152.4 mg/dLStandard Deviation 41.4
Secondary

Pulse at 6 Months

Clinical Characteristics at 6 month for Pulse

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Education InterventionPulse at 6 Months70.3 beats per minuteStandard Deviation 14
Secondary

Pulse at Baseline

Clinical Characteristics at Baseline for Pulse

Time frame: baseline

ArmMeasureValue (MEAN)Dispersion
Education InterventionPulse at Baseline73.2 beats per minuteStandard Deviation 20.9
Secondary

Weight at 6 Months

Clinical Characteristics at 6 months for Weight

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Education InterventionWeight at 6 Months219.4 poundsStandard Deviation 48.9
Secondary

Weight at Baseline

Clinical Characteristics at Baseline for Weight

Time frame: baseline

ArmMeasureValue (MEAN)Dispersion
Education InterventionWeight at Baseline223.0 poundsStandard Deviation 2.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026