Medication Adherence With Polyglot Meducation

NCT01744392 | Completed Results

• 1 other identifier: 01658
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Diabetes; Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (8)

• Blood Pressure at Baseline

  baseline

• Blood Pressure at 6 Months

  6 months

• Cholesterol & Creatinine Levels at Baseline

  baseline

• Cholesterol & Creatinine Levels at 6 Months

  6 months

• Weight at Baseline

  baseline

Study Arms (1)

education intervention

EXPERIMENTAL

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

education intervention BEHAVIORAL

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.

education intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Durham VA Medical Center: lead

Study Sites (1)

Durham VA Medical Center

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Hypercholesterolemia

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Results Point of Contact

• Title: Hayden B. Bosworth, PhD
• Organization: Health Services Research & Development, Durham VAMC

hayden.bosworth@va.gov

919-286-0411

Study Officials

• Hayden B Bosworth, PhD

  Durham VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 6, 2012
• Study Start: February 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 24, 2015
• Results First Posted: November 24, 2015

Record last verified: 2015-10

Locations

US (1)