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CompletedNCT01744392Updated Nov 24, 2015Results posted

Medication Adherence With Polyglot Meducation

An interventional study of education intervention in Hypertension, Diabetes and Hypercholesterolemia, sponsored by Durham VA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-24.

Sponsored by Durham VA Medical Center · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertension
  • Diabetes
  • Hypercholesterolemia
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 23 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Durham VA Medical Center is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: education intervention

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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Blood Pressure at Baseline

    Clinical Characteristics at Baseline for Systolic \& Diastolic Blood Pressure,

    Time frame: baseline

  2. Blood Pressure at 6 Months

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

    Time frame: 6 months

  3. Cholesterol & Creatinine Levels at Baseline

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

    Time frame: baseline

  4. Cholesterol & Creatinine Levels at 6 Months

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

    Time frame: 6 months

  5. Weight at Baseline

    Clinical Characteristics at Baseline for Weight

    Time frame: baseline

  6. Weight at 6 Months

    Clinical Characteristics at 6 months for Weight

    Time frame: 6 months

  7. Pulse at Baseline

    Clinical Characteristics at Baseline for Pulse

    Time frame: baseline

  8. Pulse at 6 Months

    Clinical Characteristics at 6 month for Pulse

    Time frame: 6 months

07

Results

Posted Nov 24, 2015

Participant flow

Participant flow — Overall Study
MilestoneEducation Intervention
Started23
Completed22
Not completed1
Withdrew: Physician decision1

Outcome measures

PrimaryMedication 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
Reported as:
Mean · percentage of medication possession
Medication Possession Ratio at Baseline
percentage of medication possessionEducation Intervention
Medication Possession Ratio at Baseline65.0 ± 1.14
PrimaryMedication 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
Reported as:
Mean · percentage of medication possession
Medication Possession Ratio at 6 Months
percentage of medication possessionEducation Intervention
Medication Possession Ratio at 6 Months68.2 ± 0.28
Statistical analysis
  • Education Intervention · t-test, 2 sided · p = .73 · Mean difference (final values): 3.2
SecondaryBlood Pressure at Baseline

Clinical Characteristics at Baseline for Systolic \& Diastolic Blood Pressure,

Time frame:
baseline
Reported as:
Mean · mmHg
Blood Pressure at Baseline
mmHgEducation Intervention
Systolic Blood Pressure130.06 ± 15.1
Diastolic Blood Pressure76.6 ± 8.0
SecondaryBlood Pressure at 6 Months

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

Time frame:
6 months
Reported as:
Mean · mmHg
Blood Pressure at 6 Months
mmHgEducation Intervention
Systolic Blood Pressure130.1 ± 18.4
Diastolic Blood Pressure75.1 ± 10.4
SecondaryCholesterol & Creatinine Levels at Baseline

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

Time frame:
baseline
Reported as:
Mean · mg/dL
Cholesterol & Creatinine Levels at Baseline
mg/dLEducation Intervention
LDL Cholesterol77.0 ± 17.4
HDL Cholesterol45.1 ± 19.5
Total Cholesterol152.4 ± 41.4
Creatinine1.1 ± 0.2
SecondaryCholesterol & Creatinine Levels at 6 Months

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

Time frame:
6 months
Reported as:
Mean · mg/dL
Cholesterol & Creatinine Levels at 6 Months
mg/dLEducation Intervention
LDL Cholesterol82.3 ± 16.9
HDL Cholesterol46.4 ± 26.1
Total Cholesterol160.0 ± 41.7
Creatinine1.2 ± 0.3
SecondaryWeight at Baseline

Clinical Characteristics at Baseline for Weight

Time frame:
baseline
Reported as:
Mean · pounds
Weight at Baseline
poundsEducation Intervention
Weight at Baseline223.0 ± 2.9
SecondaryWeight at 6 Months

Clinical Characteristics at 6 months for Weight

Time frame:
6 months
Reported as:
Mean · pounds
Weight at 6 Months
poundsEducation Intervention
Weight at 6 Months219.4 ± 48.9
SecondaryPulse at Baseline

Clinical Characteristics at Baseline for Pulse

Time frame:
baseline
Reported as:
Mean · beats per minute
Pulse at Baseline
beats per minuteEducation Intervention
Pulse at Baseline73.2 ± 20.9
SecondaryPulse at 6 Months

Clinical Characteristics at 6 month for Pulse

Time frame:
6 months
Reported as:
Mean · beats per minute
Pulse at 6 Months
beats per minuteEducation Intervention
Pulse at 6 Months70.3 ± 14.0

Adverse events

Collected over From enrollment through study completion (6 months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Education Intervention—14/23 (60.9%)0/23 (0%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventEducation Intervention
InfectionsInfections and infestations3/23
ER visitGeneral disorders3/23
ER visitMusculoskeletal and connective tissue disorders3/23
Vascular EventVascular disorders2/23
ER visitRespiratory, thoracic and mediastinal disorders2/23
HospitalizationCardiac disorders2/23
ERGastrointestinal disorders2/23
ER visitInjury, poisoning and procedural complications1/23
ER visitPsychiatric disorders1/23
HospitalizationRenal and urinary disorders1/23

Baseline characteristics

Age, Continuous
Age, Continuous(years)Education Intervention
Mean66.6 ± 8.4
Sex: Female, Male
Sex: Female, Male(Participants)Education Intervention
Female2
Male21
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Education Intervention
Caucasian9
African American14
Region of Enrollment
Region of Enrollment(participants)Education Intervention
United States23
Health Literacy
Health Literacy(participants)Education Intervention
Low Health Literacy9
High Health Literacy14
Employed (full or part-time)
Employed (full or part-time)(participants)Education Intervention
Employed7
Not Employed16
08

Study locations

1 site
  • Durham VA Medical Center
    Durham, North Carolina 27701, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01744392
Lead sponsor
Durham VA Medical Center
Responsible party
Sponsor
First posted
Dec 6, 2012
Start date
Feb 2013
Primary completion
Jun 2014
Completion
Jul 2014
Results posted
Nov 24, 2015
Last update
Nov 24, 2015

Study contacts

Hayden B Bosworth, PhD
principal investigator · Durham VA Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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