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Medication Adherence With Polyglot Meducation

Primary Purpose

Hypertension, Diabetes, Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
education intervention
Sponsored by
Durham VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Durham VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

education intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Blood Pressure at Baseline
Clinical Characteristics at Baseline for Systolic & Diastolic Blood Pressure,
Blood Pressure at 6 Months
Clinical Characteristics at 6 months for Systolic & Diastolic Blood Pressure,
Cholesterol & Creatinine Levels at Baseline
Clinical Characteristics at Baseline for LDL, HDL,Total Cholesterol and Creatinine
Cholesterol & Creatinine Levels at 6 Months
Clinical Characteristics at 6 months for LDL, HDL,Total Cholesterol and Creatinine
Weight at Baseline
Clinical Characteristics at Baseline for Weight
Weight at 6 Months
Clinical Characteristics at 6 months for Weight
Pulse at Baseline
Clinical Characteristics at Baseline for Pulse
Pulse at 6 Months
Clinical Characteristics at 6 month for Pulse

Full Information

First Posted
December 5, 2012
Last Updated
October 22, 2015
Sponsor
Durham VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01744392
Brief Title
Medication Adherence With Polyglot Meducation
Official Title
Evaluate Changes in Medication Adherence and Patient Perspective of Polyglot Systems, Inc's Meducation Technology
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Durham VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes, Hypercholesterolemia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
education intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
education intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication Possession Ratio at Baseline
Description
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
Title
Medication Possession Ratio at 6 Months
Description
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
Secondary Outcome Measure Information:
Title
Blood Pressure at Baseline
Description
Clinical Characteristics at Baseline for Systolic & Diastolic Blood Pressure,
Time Frame
baseline
Title
Blood Pressure at 6 Months
Description
Clinical Characteristics at 6 months for Systolic & Diastolic Blood Pressure,
Time Frame
6 months
Title
Cholesterol & Creatinine Levels at Baseline
Description
Clinical Characteristics at Baseline for LDL, HDL,Total Cholesterol and Creatinine
Time Frame
baseline
Title
Cholesterol & Creatinine Levels at 6 Months
Description
Clinical Characteristics at 6 months for LDL, HDL,Total Cholesterol and Creatinine
Time Frame
6 months
Title
Weight at Baseline
Description
Clinical Characteristics at Baseline for Weight
Time Frame
baseline
Title
Weight at 6 Months
Description
Clinical Characteristics at 6 months for Weight
Time Frame
6 months
Title
Pulse at Baseline
Description
Clinical Characteristics at Baseline for Pulse
Time Frame
baseline
Title
Pulse at 6 Months
Description
Clinical Characteristics at 6 month for Pulse
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hayden B Bosworth, PhD
Organizational Affiliation
Durham VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States

12. IPD Sharing Statement

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Medication Adherence With Polyglot Meducation

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