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
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.
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.
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 →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.
Exclusion Criteria:
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
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
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
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
Blood Pressure at Baseline
Clinical Characteristics at Baseline for Systolic \& Diastolic Blood Pressure,
Time frame: baseline
Blood Pressure at 6 Months
Clinical Characteristics at 6 months for Systolic \& Diastolic Blood Pressure,
Time frame: 6 months
Cholesterol & Creatinine Levels at Baseline
Clinical Characteristics at Baseline for LDL, HDL,Total Cholesterol and Creatinine
Time frame: baseline
Cholesterol & Creatinine Levels at 6 Months
Clinical Characteristics at 6 months for LDL, HDL,Total Cholesterol and Creatinine
Time frame: 6 months
Weight at Baseline
Clinical Characteristics at Baseline for Weight
Time frame: baseline
Weight at 6 Months
Clinical Characteristics at 6 months for Weight
Time frame: 6 months
Pulse at Baseline
Clinical Characteristics at Baseline for Pulse
Time frame: baseline
Pulse at 6 Months
Clinical Characteristics at 6 month for Pulse
Time frame: 6 months
| Milestone | Education Intervention |
|---|---|
| Started | 23 |
| Completed | 22 |
| Not completed | 1 |
| Withdrew: Physician decision | 1 |
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.
| percentage of medication possession | Education Intervention |
|---|---|
| Medication Possession Ratio at Baseline | 65.0 ± 1.14 |
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.
| percentage of medication possession | Education Intervention |
|---|---|
| Medication Possession Ratio at 6 Months | 68.2 ± 0.28 |
Clinical Characteristics at Baseline for Systolic \& Diastolic Blood Pressure,
| mmHg | Education Intervention |
|---|---|
| Systolic Blood Pressure | 130.06 ± 15.1 |
| Diastolic Blood Pressure | 76.6 ± 8.0 |
Clinical Characteristics at 6 months for Systolic \& Diastolic Blood Pressure,
| mmHg | Education Intervention |
|---|---|
| Systolic Blood Pressure | 130.1 ± 18.4 |
| Diastolic Blood Pressure | 75.1 ± 10.4 |
Clinical Characteristics at Baseline for LDL, HDL,Total Cholesterol and Creatinine
| mg/dL | Education Intervention |
|---|---|
| LDL Cholesterol | 77.0 ± 17.4 |
| HDL Cholesterol | 45.1 ± 19.5 |
| Total Cholesterol | 152.4 ± 41.4 |
| Creatinine | 1.1 ± 0.2 |
Clinical Characteristics at 6 months for LDL, HDL,Total Cholesterol and Creatinine
| mg/dL | Education Intervention |
|---|---|
| LDL Cholesterol | 82.3 ± 16.9 |
| HDL Cholesterol | 46.4 ± 26.1 |
| Total Cholesterol | 160.0 ± 41.7 |
| Creatinine | 1.2 ± 0.3 |
Clinical Characteristics at Baseline for Weight
| pounds | Education Intervention |
|---|---|
| Weight at Baseline | 223.0 ± 2.9 |
Clinical Characteristics at 6 months for Weight
| pounds | Education Intervention |
|---|---|
| Weight at 6 Months | 219.4 ± 48.9 |
Clinical Characteristics at Baseline for Pulse
| beats per minute | Education Intervention |
|---|---|
| Pulse at Baseline | 73.2 ± 20.9 |
Clinical Characteristics at 6 month for Pulse
| beats per minute | Education Intervention |
|---|---|
| Pulse at 6 Months | 70.3 ± 14.0 |
Collected over From enrollment through study completion (6 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Education Intervention | — | 14/23 (60.9%) | 0/23 (0%) |
| Event | Education Intervention |
|---|---|
| InfectionsInfections and infestations | 3/23 |
| ER visitGeneral disorders | 3/23 |
| ER visitMusculoskeletal and connective tissue disorders | 3/23 |
| Vascular EventVascular disorders | 2/23 |
| ER visitRespiratory, thoracic and mediastinal disorders | 2/23 |
| HospitalizationCardiac disorders | 2/23 |
| ERGastrointestinal disorders | 2/23 |
| ER visitInjury, poisoning and procedural complications | 1/23 |
| ER visitPsychiatric disorders | 1/23 |
| HospitalizationRenal and urinary disorders | 1/23 |
| Age, Continuous(years) | Education Intervention |
|---|---|
| Mean | 66.6 ± 8.4 |
| Sex: Female, Male(Participants) | Education Intervention |
|---|---|
| Female | 2 |
| Male | 21 |
| Race/Ethnicity, Customized(participants) | Education Intervention |
|---|---|
| Caucasian | 9 |
| African American | 14 |
| Region of Enrollment(participants) | Education Intervention |
|---|---|
| United States | 23 |
| Health Literacy(participants) | Education Intervention |
|---|---|
| Low Health Literacy | 9 |
| High Health Literacy | 14 |
| Employed (full or part-time)(participants) | Education Intervention |
|---|---|
| Employed | 7 |
| Not Employed | 16 |
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Durham VA Medical Center